285 Clinical Trials for Various Conditions
This study evaluates patient acceptability of whole body magnetic resonance imaging (WBM) and liquid biopsies (LB) in detecting early stage cancer in patients with a strong family history of cancer. Collecting family history and testing for genes passed on from parent to child (germline testing) can be used to predict the likelihood of a patient developing cancer. Currently, detection of early cancers focuses on screening specific organ systems such as breast and colon cancer. Magnetic resonance imaging (MRI) uses a large magnet and radio waves to look at organs and structures inside the body. Health care professionals use MRI scans to diagnose a variety of conditions, from torn ligaments to cancer. Liquid biopsy is test that analyzes blood samples to determine if cancer cells are present. This study may help researchers determine the feasibility of WBM and liquid biopsies to detect early stage cancer in patients that have a strong family history of cancer.
Investigators from Vanderbilt University Medical Center (VUMC), Duke University, and Meharry Medical College (MMC) are collaborating on a family health history study to deploy a family health history (FHH) platform, MeTree. Recruited participants will complete surveys, the MeTree questionnaire, and MeTree will determine the participant's cancer risk based on current guidelines. The study team will offer genetic counseling to high-risk participants. Investigators will track participant outcomes and behaviors from the use of MeTree to determine the efficiency of the use of MeTree compared to completion of pedigrees in clinic.
This pilot clinical trial studies how well the "JeffQuit" group therapy program works in enabling patients with a history of cancer to quit smoking. The JeffQuit program uses group therapy to provide psychological support and address the mental need for smoking, the habit or routine it creates, and the physical need for nicotine. It is not yet known how well the JeffQuit program will work in helping patients with a history of cancer to stop smoking.
This is a retrospective observational study to determine the proportion of patients with a family history of pancreatic cancer and other malignancies among patients who have intraductal papillary mucinous neoplasm (IPMN). The investigators will be reviewing the demographic, clinical, radiologic, pathologic, and follow-up information from the Pancres Center database. The investigators will also conduct a chart review to collect information recorded by clinicians on each subject's family history of malignancy and personal history of malignancy. Results of this database and chart review will be incorporated into a datasheet in which all patient identifiers have been removed. The primary outcome will be the percentage of IPMN patients with at least one first-degree relative with pancreatic cancer or IPMN, or at least two first or second degree relatives with pancreatic cancer, IPMN, or malignancies related to pancreatic cancer syndromes, including colorectal, gastric, breast, ovarian, and melanoma neoplasms. Secondary outcomes will be the relative risk of IPMN subtypes of higher malignant potential (main duct or mixed type location), more advanced histology (carcinoma in situ or invasive carcinoma), and recurrence following surgical resection amongst subjects with a family history.
RATIONALE: Studying gene mutations in samples of DNA from patients with head and neck cancer and a family history of cancer may help doctors learn more about the development of cancer in families. PURPOSE: This clinical trial is studying germline mutations in patients with head and neck cancer and a family history of cancer.
Family history of cancer is an important possible indicator of inherited cancer susceptibility, which has helped identify individuals and families at high risk of inherited cancers in research studies and clinical practice. While there are also various potential uses of family history of cancer data in cancer surveillance, the completeness and accuracy of family history of cancer data collected from the general population is unclear. In an effort to evaluate the feasibility of conducting a national surveillance study to determine the prevalence of family history of cancer in the U.S. population, the Risk Factor Monitoring and Methods Branch will undertake a pilot study, entitled the Family Health Study, that examines issues of data quality. In this study, a family history of cancer questionnaire (FHCQ) will be developed for surveillance purposes and administered to a random digit dial (RDD) sample of households in the state of Connecticut. Positive and negative reports of common cancers in the respondent's families will be validated against records of the Connecticut Tumor Registry (CTR) and other data sources. The objectives are to: 1) assess the agreement between respondent reports of specific cancers in first and second degree relatives and medical record-based reports, as measured by percent concordance; 2) quantify the sensitivity, specificity and predictive value of the FHCQ by cancer site; 3) evaluate the possible predictors of reporting accuracy, including cancer site, year of diagnosis, kinship relation of the relative to the respondent and the frequency and quality of their contact, overall family cohesiveness, respondent's own history of cancer, and demographic factors; 4) describe the completeness and reliability of family structure data. Validation of selected relatives' cancer status will be done through data linkage to the Connecticut Tumor Registry, other selected cancer registries, the National Death Index, Medicare claims data bases, state death certificate registries, or by obtaining consent to review available medical records from physicians and health care facilities. Self-reports of respondents' cancer status will also be validated since this may be a predictor of ability to accurately report family history. A pre-established tracing algorithm will be used to triage cancer reports into the medical records systems where true cancer status is most likely to be verified by the highest quality data. Validated cancer outco...
This study uses new methods called "genome sequencing" that allow the investigators to study part or all of a person's genome. The genome is the collection of all of a person's genes. Genes carry the instructions that our bodies need to develop and function. Genes are passed on from one generation to the next. Genome sequencing can study all of a person's genome (whole genome sequencing) or just parts of their genome (whole exome sequencing). In the study, the investigators refer to all these research methods as 'genome sequencing'. Genome sequencing typically shows a large number of gene changes, known as "variants." Some (but not all) of these genetic variants may be linked to increased risks of diseases other than cancer. The purpose of this study is to learn what kinds of genetic variants the patient wants to learn about from their genome.
The primary purpose of this study is to compare three interventions, two experimental and one standard of care (usual care), to see if the experimental interventions will increase the likelihood of a participant obtaining guideline-concordant genetic testing. Eligible participants will be randomized (assigned) to one of the following interventions: 1) Virtual genetics navigator, a mobile-optimized website, designed by the investigators, that delivers tailored messages and content; 2) two motivational interviewing (MI) telephone calls delivered by trained genetics health coaches; or 3) usual care.
The purpose of this study is to find out if a psychotherapy method called behavioral activation (BA) can be successfully delivered by telephone or videoconference (remotely) and can effectively treat depression in Older Adult Cancer Survivors (OACS)
The purpose of this study is to establish a registry of patients with pancreatic diseases. Patients included in the registry may include those with: pancreatic cancer, precancerous lesions of the pancreas, inflammatory lesions of the pancreas, cystic lesions of the pancreas, and patients at high-risk of pancreatic cancer such as those with a family history of pancreatic cancer or with a family history of a syndrome known to be associated with pancreatic cancer. Pancreatic cancer is the fourth leading cause of death from cancer in the United States. However, little is known about the development of pancreatic cancer and pancreatic diseases in individuals with the above conditions. Knowledge of how family history, environmental exposures, and inflammatory lesion of the pancreas contribute to the development of pancreatic cancer and pancreatic diseases is essential. You may qualify to take part in this research study because you have inflammation in the pancreas, a pancreatic cyst, pre-cancerous lesions of the pancreas, pancreatic cancer, a family history of pancreatic cancer, or a family history of a syndrome known to be associated with pancreatic cancer. We will also be collecting a blood sample from all participants for DNA isolation. Sometimes we are born with genes or DNA that give us an increased or decreased chance of developing an illness later in life. Genetic material will be isolated from your blood for further study. You may also choose to provide additional blood samples for serum and plasma extraction. Serum and plasma are components of the blood which can be used to measure indicators of disease in the blood, called biomarkers,for pancreatic diseases. Clinical data and biological specimens contained in this study may be used for a wide variety of future related studies to the cause, diagnosis, outcome and treatment of pancreatic cancer. Funds for conducting this research are provided by Mount Sinai.
The goal of this study is to understand factors which may influence risk for colorectal and other cancers in families. These factors include genetic variability, in combination with diet and lifestyle. In order to achieve these goals, we need to contact as many eligible participants as possible.
This proposed pilot study is to conduct detailed interviews into the medical, environmental, and family histories The second phase of this study project is to and to collect blood specimen to obtain DNA. The Blood specimen and DNA will be processed by the Rutgers University Cell and DNA Repository (RUCDR) and stored for a second phase of this pilot. The purpose is to rule out Familial Multiple Endocrine Neoplasia (MEN 1), and succinate dehydrogenase complex, subunit D (SDHD), gene inactivation thought to be associated with different types of carcinoid cancer.
This clinical trial studies whether personalized education and genetic counseling increases genetic testing in patients with a known family history of pancreatic cancer. Approximately 10% of pancreatic cancer cases are genetically linked and therefore, if a gene is found that could put a patient at risk, it could guide the patient to obtain more frequent screening for pancreatic cancer and possibly detect it earlier when it is more treatable. The current National Comprehensive Cancer Network (NCCN) guidelines suggest patients with a first-degree relative (parent, sibling, child) with pancreatic cancer be referred for a genetics consultation to discuss genetic testing if the affected family member cannot be tested. Personalized education is based on the patient's family history of pancreatic cancer and offers information regarding the current NCCN guidelines. This may be an effective method to increase patients' understanding of their pancreatic cancer risk and the NCCN guidelines. Genetic counseling is provided by an expert in hereditary disorders. The patient's family and personal medical history may be discussed, and counseling may lead to genetic testing. Personalized education and genetic counseling may increase genetic testing in patients with a known family history of pancreatic cancer.
This is a prospective clinical trial that will examine if biennial contrast-enhanced mammography added to annual 3D mammography (tomosynthesis) substantially improves breast cancer detection with minimal increase in false-positives, in women with a personal history of breast cancer.
The overall goal of this study is to reduce breast cancer morbidity and mortality disparities among African American women by actively engaging family history as a tool to modify screening regimens and enhance communication between women and their providers. Therefore, this rationale is reflected the project title: "You cannot change your family history, but you can change what you do with it: A peer-based education program to reduce breast cancer risk in African American women" This study will develop and test an educational curriculum that highlights the importance of knowing family history and sharing it with health care providers. The curriculum will include tools to gather family history and discuss it with providers to guide the delivery of care. The investigators will assess the effectiveness of the curriculum in group and one-on-one settings and when delivered by a Patient Ambassador (peer train-the trainer model) or a researcher. The specific objectives of the study are to: Obj. 1: Develop a CBPR-based curriculum- using a community based participatory research (CBPR) approach, that highlights the importance of family history as a risk factor for breast cancer that includes tools to collect family history information and discuss it with providers to enable a family history based screening regimen. Obj. 2: Train Patient Ambassadors- Patient Ambassadors, women from the community who act as community messengers to deliver the curriculum. Obj. 3: Pilot Implementation and Extensive Evaluation of the Curriculum- Assess two modes of delivery, group vs one-on-one, and Peer Ambassadors vs. a researcher. Obj. 4: Dissemination- of the curricular products, implementation pilot results, and implementation guides for communities and practices- via publications and other channels in preparation for grant submits to enhance the program.
This trial studies how well EMBr Wave technology works in reducing hot flashes in women with a history of breast cancer. Hot flashes are a common symptom experienced by menopausal women. The standard treatment for hot flashes is hormone replacement therapy, however hormone replacement therapy cannot be used in women with a history of, or active, breast cancer. EMBr Wave is a personal heating and cooling device worn on the wrist. EMBr Wave may help reduce hot flash severity in women with a history of breast cancer.
Background: Tumors in the genitourinary tracts can occur in the kidney, bladder, prostate, and testicles and can have common and rare histologies. Some cancers that occur along the genitourinary (GU) tract are rare. Some GU tumors are so rare that they are not included in treatment studies or tissue banks. This makes it hard for researchers to determine standards of care. Researchers want to learn more about common and rare GU tumors. Objective: To learn more about urinary tract cancers. Eligibility: People ages 18 and older with urinary tract or GU cancer such as bladder, kidney, testicular, prostate, penis, or neuroendocrine cancer. Design: Participants will be screened with questions about their medical history. Their medical records will be reviewed. Participants will have a physical exam. They will give blood and urine samples. They will complete a survey about their family cancer history. Clinical photographs will be taken to document skin lesions. Participants may have imaging scans of their chest, abdomen, and pelvis. They may have a contrast agent injected into their arm. Participants will get recommendations about how to best manage and treat their cancer. They can ask as many questions as they would like. Participants will provide existing tumor samples if available. They may have optional tumor biopsies up to twice a year. For needle biopsies, the biopsy area will be numbed and they will get a sedative. A needle will be inserted through their skin to collect a tumor sample. For skin biopsies, their skin will be numbed. A small circle of skin will be removed. Some blood and tumor samples may be used for genetic tests. Participants will have frequent follow-up visits. If they cannot visit NIH, their home doctor will be contacted. They will be followed on this study for life....
The purpose of this study is to identify novel gene mutations which have contributed to significant personal and family history of cancer. Adults with and without cancer will be accrued to the study. Participants qualify to take part in this research study because someone in their family has been diagnosed with or because they themselves have a cancer diagnosis. Participants' DNA and other clinical information will be obtained from a blood sample in order to study the genetic basis of cancer and related complications. All portions in the DNA that code for proteins (i.e., the exome) will be studied. Participant DNA sample and information about family structure and family medical history and ethnic origin may also be collected to better understand this information. Clinical information will be stored and biological samples, including DNA, will be kept for up to three (3) years after collection for future. Ultimately, once identified, the role of the specific genetics changes in the development of inherited cancer(s) will be characterized.
In the United States, carriers of hereditary genetic mutations have up to an 85% risk of developing breast cancer compared to 12% in the general population. Overall uptake of genetic services is generally low, particularly among high-risk African American (AA) women, who carry a disproportionate burden of breast cancer mortality. Further, although testing close relatives of individuals who test positive for a pathogenic variant might curtail breast cancer disparities attributable to hereditary risk, it is unclear how counseled or tested individuals influence their social and familial networks. Using a randomized control trial design, the objective of this research project is to test the effectiveness of a culturally targeted video, previously developed by our research team, on promoting genetic counseling attendance among AA women determined to be at high risk for breast cancer through cancer genetic risk assessment in a clinical setting. This study will also test how psychosocial factors (knowledge, intrinsic motivation, risk perception, and distress) impact the relationships between intervention exposures (video versus brochure) and compare the impact of intervention exposures on diffusion of knowledge about genetic counseling through social network analysis.
This study aims to identify the optimal method to recognize, risk stratify, and provide follow-up care for individuals at risk of hereditary cancer. The study team will conduct a Hybrid Type II comparative effectiveness-implementation trial, with a mixed methods component and process/formative evaluations for stakeholder engagement. The study team will evaluate three methods for identifying and risk-stratifying individuals at risk of hereditary cancer and providing post-risk stratification longitudinal care.
This is a single institution, randomized, placebo-controlled, double-blind phase IIB trial of 1) topical diclofenac and topical DFMO, or 2) placebo in participants with a history of non melanoma skin cancer/ keratinocytic cancers.
This is a prospective clinical trial that will examine if contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false-positives, in women with a personal history of breast cancer.
Background: Pregnant women can get a DNA analysis of their blood. The test tells a woman and her doctor about the DNA of her unborn baby. But some women get test results that are abnormal or not reportable. Researchers want to learn more about the relationship between these test results and cancer. Objective: To better understand prenatal DNA test results and how they can predict cancer, if present, in pregnant women. Eligibility: Women 18 and older who got prenatal DNA test results that were abnormal or not reportable and suggested the abnormality was in the woman and not her baby. Design: Potential participants will be screened by phone or in person. They will talk about their medical history and send copies of their medical records. Eligible participants will have a physical exam and medical history. They will give blood and stool samples. They may have a Pap smear. They will talk to a specialist about the test results they got when they were pregnant. Participants will have magnetic resonance imaging (MRI). They will lie on a table that slides in and out of a metal tube, taking pictures. Participants will complete a paper or electronic survey. It will assess their emotional well-being. Participants will get a list of any possible diagnoses and treatment options. Participants may be followed for up to 5 years. They may give blood samples and copies of their medical records. This can be done without traveling to the NIH. In some cases, people might come back to the NIH in one year to see if anything has changed.
Voided urinary cytology (VUC) is the most widely used urine-based assay for detecting bladder cancer (BCa); however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Furthermore, the detection rate of VUC for recurrent BCa is not much better. Because of this severe limitation, all patients who are under surveillance to monitor for recurrent BCa must undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder and the bladder inspected (cystoscopy). We propose to improve the non-invasive detection of recurrent BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples.
This research study is evaluating bone mineral density in childhood cancer survivors who have a history of bone fracture.
Conflicting guideline recommendations for screening colonoscopy result due to scant data upon which to develop appropriate recommendations. No previous study has compared the prevalence of advanced adenomas or adenomas (any size) among 40-49 year old individuals with a first degree relative (FDR) with colorectal cancer (CRC) versus 40-49 year old average risk individuals with no family history of CRC. The purpose of this study is to determine the prevalence of colon adenomas in 40-49 year old individuals and identify risk factors associated with the presence of advanced adenomas. This data will provide evidence to determine appropriate colon cancer screening guidelines in 40-49 year old persons with a family history of colon polyps or colorectal cancer.
RATIONALE: Magnesium oxide may help relieve hot flashes symptoms in women with a history of breast cancer. PURPOSE: This randomized clinical trial studies how well a high-dose or a low-dose of magnesium oxide works compared to placebo in treating menopausal women with hot flashes and a history of breast cancer.
RATIONALE: Estrogen can relieve the symptoms of menopause, but can also cause the growth of breast cancer cells. Flaxseed may reduce the number of hot flashes and improve mood and quality of life in postmenopausal women not receiving estrogen therapy. PURPOSE: This randomized phase III trial is studying flaxseed to see how well it works in treating postmenopausal women with hot flashes who have a history of breast cancer or other cancer or who do not wish to take estrogen therapy.
RATIONALE: Studying samples of blood in the laboratory from patients with current or previous cancer may help doctors learn more about biomarkers related to cancer. PURPOSE: This research study is looking at blood samples in women with breast cancer or a history of breast cancer.
The purpose of this study is to determine the difference of skin carotenoid levels between subjects with previous squamous cell carcinomas (SCC), subjects with previous basal cell carcinomas (BCC) and a control group.