Treatment Trials

267 Clinical Trials for Various Conditions

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RECRUITING
Tempus CRC Surveillance Study: a CtDNA Biomarker Profiling Study of Patients with CRC Using NGS Assays
Description

The study is an observational multicenter evaluation of participants with colorectal cancer (CRC) who will receive longitudinal plasma ctDNA biomarker profiling in addition to their standard-of-care therapy and disease surveillance.

COMPLETED
Efficacy and Safety of Olaparib (MK-7339) With or Without Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Unresectable or Metastatic Colorectal Cancer (CRC) (MK-7339-003/LYNK-003)
Description

This is an efficacy and safety study of olaparib alone or in combination with bevacizumab being compared to bevacizumab with a fluoropyrimidine in participants with unresectable or metastatic colorectal cancer who have not progressed following first-line induction. The primary hypotheses are: Olaparib + Bevacizumab is superior to a fluoropyrimidine + Bevacizumab with respect to progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR); Olaparib is superior to a fluoropyrimidine + Bevacizumab with respect to PFS using RECIST 1.1 as assessed by BICR. As of amendment 5 study enrollment is being discontinued and study participants randomized to one of the two experimental arms (olaparib plus bevacizumab or olaparib monotherapy) must discontinue study intervention. Participants who are still on study treatment will no longer have tumor response assessments by BICR.

COMPLETED
Colorectal Cancer (CRC) Surveillance Tool: Cognitive and Pilot Testing
Description

The goal of this research study to help develop a tool to assist patients in making decisions about care during treatment for colorectal cancer. Information collected during this study will be saved to help develop future studies about patient decision making in cancer treatment.

COMPLETED
A Patient Portal Tool, E-assist, for Supporting CRC Screening
Description

To compare patient perceptions, intent to screen, and screening use among those using a patient portal with and without a colorectal cancer (CRC) screening decision support tool, e-assist. To evaluate whether the effectiveness of e-assist is moderated by multi-level factors, including patient health literacy, decision-making preference, and CRC screening decision stage. To assess program impact and create an implementation guide for e-assist by combining results from Aims 1 \& 2, a program implementation analysis/process evaluation and the perspectives of staff from future diverse implementation sites including small primary care practices, University-based primary practices and federally-qualified health centers.

COMPLETED
R-21 Colorectal Cancer Screening (CRCS) Pilot Trial
Description

The goal of this study is to test patient education program for decision making about colorectal cancer (CRC) screening in community health centers.

COMPLETED
Colon Cancer Screening in First-Degree Relatives of Hispanic Colorectal Cancer (CRC) Patients
Description

Primary Objectives: 1. To evaluate knowledge, beliefs, attitudes and values that influence perceptions and utilization of colorectal cancer screening (CRCS) among first-degree relatives of Hispanic CRC patients. 2. To assess factors influencing Hispanic CRC patients' communication of CRC risk and screening information to their FDRs. Secondary Objective: 1) To establish the feasibility of recruiting Hispanic CRC patients and their FDRs from the institutional patient database and/or MDACC clinics.

COMPLETED
Screening for Familial Colorectal Cancer (CRC) Patients
Description

The goal of this psychosocial research study is to learn about the knowledge, beliefs, and attitudes that people have toward screening for colorectal cancer. Another goal is to study how families communicate about colorectal cancer risk and colorectal cancer screening, with each other and with health care providers. Objectives: 1. To evaluate psychosocial and external factors influencing colorectal cancer (CRC) patients' communication with their first-degree relatives (FDRs) about CRC risk and screening information. Using measures of knowledge, health beliefs and behavior, family closeness, openness and motivation to discuss CRC and screening, distress, provider support and background variables (sociodemographics, access to care, and medical history), we will conduct a cross-sectional study to evaluate factors influencing CRC patients' communication about CRC risk and screening information to their FDRs. 2. To evaluate psychosocial and external factors associated with CRC screening behavior among first-degree relatives of CRC patients. Using measures of knowledge, health beliefs and behavior, family closeness and subjective norms, distress, provider interactions, benefits/barriers, and background variables (race/ethnicity, sociodemographics, access to care, and medical history), we will conduct a cross-sectional study of FDRs of CRC patients recruited under Aim 1 to evaluate factors associated with CRC screening behavior (specifically, colonoscopy adherence).

RECRUITING
Phase 2 Study of SR-8541A in Combination with Botensilimab and Balstilimab in Subjects with Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)
Description

This is an open-label, dose escalation and expansion, multi-center phase 2 study evaluating the safety and efficacy of SR-8541A administered orally in combination with intravenous botensilimab and balstilimab in subjects with MSS-CRC with and without active liver metastases.

RECRUITING
Y-90, Capecitabine, and Atezolizumab for Oligometastatic CRC
Description

BrUOG-430 is a prospective, single-arm, phase 2 trial evaluating yttrium-90 radioembolization in combination with capecitabine and atezolizumab for the treatment of unresectable colorectal cancer liver metastases in individuals who have been treated with two or more lines of systemic therapy.

RECRUITING
Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC
Description

This study is a multi-indication, open-label, single-treatment arm, parallel-cohort phase II study of enfortumab vedotin in adult participants with advanced or metastatic colorectal cancer (CRC) or hepatocellular carcinoma (HCC) who have been previously treated with one or more lines of systemic therapy.

RECRUITING
Study of Safety and Efficacy of RGT-61159 in Adults with Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
Description

Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC

RECRUITING
Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD)
Description

To find the highest and/or recommended dose of TROP2-CAR-NK cells combined with cetuximab in participants with MRD CRC.

RECRUITING
Blood-Based Colorectal Cancer (CRC) Screening Implementation Into Clinical Practice Highlands
Description

This is a prospective implementation study that will include patients that are identified as being average risk for colorectal cancer (CRC) according to USPSTF guidelines and who have opted to be screened for CRC. The purpose of this study is to understand implementation of a noninvasive screening test in primary care and internal medicine clinical settings, and the impact on patient acceptability and adherence of CRC screening.

Conditions
RECRUITING
Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study
Description

The aim of this study is to characterize the microbiome and assess fatigue and cognition of patients with cancer undergoing standard of care treatment.

Conditions
RECRUITING
Impact of Protect Your Colon™ on CRC Screening
Description

The purpose of the research is to assess the impact of Protect Your Colon™, a colorectal cancer (CRC) screening decision aid, on patients' CRC screening behaviors. The Investigators hypothesize that Protect Your Colon™, through optimizing shared decision making, will lead to selection of a test that accurately matches patients' values and increase CRC screening uptake. To test this hypothesis, the investigators will conduct a pilot randomized controlled trial (RCT) to assess if provision of Protect Your Colon™ improves communication on CRC screening, intent to complete screening, and ultimately uptake of screening vs. usual care.

WITHDRAWN
Study SBX-01-101: A Stool Collection Study in Colorectal Cancer (CRC) Patients Treated With Irinotecan-Based Regimens
Description

The primary objective of the study is to determine whether there is a correlation between the intestinal side effects of chemotherapy treatment and the expression/activity profiles of glucuronidase enzymes in the stool microbiome of the target patient population.

RECRUITING
Aim 3, Optimizing CRC Screening in Patients With Diabetes in Safety-net Primary Care Settings
Description

This mixed methods study evaluates the effectiveness and feasibility of a multi-level (patient, team, organizations) intervention to optimize CRC screening for patients with diabetes in primary care safety-net settings.

ACTIVE_NOT_RECRUITING
RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC
Description

This is an open-label, Phase 2 clinical trial evaluating therapy with an oncolytic immunotherapy (RP2 or RP3) in combination with atezolizumab and bevacizumab in patients with advanced Microsatellite Stable and Mismatch Repair Proficient Colorectal Carcinoma.

ACTIVE_NOT_RECRUITING
Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening
Description

The goal of this pragmatic randomized clinical trial is to compare two colorectal (CRC) screening outreach approaches (FIT and Cologuard) in community health centers (CHC) in patients overdue for CRC screening. The main questions the project aims to answer are: What screening test has a higher completion rate? What screening test is more feasible and acceptable in a CHC setting? Patients will be sent a CRC screening test in the mail and will be asked to complete it at home and mail it back. Researchers will compare the completion rates for each screening test and will also look at the overall completion rate of both tests.

ACTIVE_NOT_RECRUITING
Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS
Description

The goal of this clinical trial is to determine the safety and efficacy of IP-001 for intratumoral injection administration following thermal ablation of a solid tumor.

ACTIVE_NOT_RECRUITING
CRC Detection Reliable Assessment With Blood
Description

The CRC DRAW study will assess the sensitivity and specificity of the blood-based, Next-Gen CRC Screening Test for the detection of CRC.

WITHDRAWN
Pembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory Colorectal Cancer (CRC)
Description

The phase II trial tests whether pembrolizumab and dendritic cell-based treatment works to shrink tumors in patients with colorectal cancer that does not respond to treatment (refractory). Pembrolizumab, also referred to as an immune checkpoint inhibitor drug, works by targeting molecules that act as a check and balance system for immune responses. Immune checkpoint inhibitor drugs are designed to either "unleash" or "enhance" the cancer immune responses that already exist by either (1) blocking inhibitory molecules or by (2) activating stimulatory molecules. Dendritic cell-based treatment works by boosting the immune system (a system in our bodies that protects us against infection) to recognize and destroy the cancer cells. This investigational treatment targets cancer cells and is made from the patient's own blood cells. Giving pembrolizumab and dendritic cell-based treatment may help shrink tumors in patients with colorectal cancer.

RECRUITING
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)
Description

The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors. This study contains 2 parts: Dose escalation (Part 1) and dose expansion (Part 2). Study details include: * Study Duration per participant: Approximately 4 months for Part 1 and 8 months for Part 2 * M9140 is not available through an expanded access program

TERMINATED
A Study of exoASO-STAT6 (CDK-004) in Patients With Advanced Hepatocellular Carcinoma (HCC) and Patients With Liver Metastases From EIther Primary Gastric Cancer or Colorectal Cancer (CRC)
Description

This is a first-in-human, Phase 1 open-label, multicenter, dose escalation, safety, pharmacodynamic, and PK study of exoASO-STAT6 (CDK-004) in patients with advanced Hepatocellular Carcinoma (HCC) and patients with liver metastases from either primary gastric cancer or colorectal cancer (CRC).

COMPLETED
Increasing Engagement With Messages Regarding CRC Screening Among Adults Aged 45-49
Description

In May of 2021, the United States Preventive Service Task Force (USPSTF) updated their colorectal cancer (CRC) screening guidelines by recommending screening at an earlier age for average-risk adults starting at the age of 45 years old (Grade B recommendation). This is in addition to their Grade A recommendations of continuing to screen average-risk adults ages 50-75 years old. As the investigators health system aims to screen the newly eligible population of average-risk patients between the ages of 45-49, the investigators proposed randomized controlled trial is aimed to determine the most effective patient outreach approach to increase patients' engagement with messages regarding CRC screening and screening uptake within this specific age-group.

WITHDRAWN
Living Donor Liver Transplantation for CRC Liver Metastases
Description

This study will test the safety and efficacy of living donor liver transplant after standard-of-care chemotherapy for participants with non-resectable liver metastases (LM) from colorectal cancer. 25 donor-recipient pairs will be enrolled (50 participants). Donors will be on study for 2 years and recipients will be on study for up to 5 years.

COMPLETED
Reminder Modality for CRC Screening
Description

This is a randomized controlled trial that will evaluate the effectiveness of different reminder modalities for a population-based mailed FIT program at the VA Puget Sound among average risk Veterans who are due for annual colorectal cancer (CRC) screening.

COMPLETED
Validation of the Drug Impaired Driving Scenario (DIDS) on the CRCDS-miniSim
Description

Subjects will participate in a 4-visit study protocol at the National Advanced Driving Simulator, part of the University of Iowa, in which they will be asked to complete assorted questionnaires, computerized cognitive tasks, and a simulator drive. Subjects will be administered 0.75 mg alprazolam (Xanax) or placebo and 500 mg vaporized cannabis (6.18% THC / \<0.025% CBD) or placebo (0% THC / 0% CBD). The primary objective of this study is to validate the Drug Impaired Driving Scenario (DIDS) using the CRCDS-2 driving simulator by assessing the acute effects of cannabis relative to placebo on simulated driving performance. Assay sensitivity will be demonstrated by the significant effect of 0.75 mg alprazolam (active comparator) on driving and cognitive endpoints.

COMPLETED
Veteran Primers for CRC Screening
Description

This is a prospective, randomized controlled trial that will evaluate the effectiveness of primer postcards sent two weeks prior to the mailing of a FIT kit in improving adherence to annual CRC screening. This project is for the purpose of quality improvement and has been designated as non-research by the VHA Office of Primary Care, Improvement \& Innovation (VHA Program Guide 1200.21).

ACTIVE_NOT_RECRUITING
Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008)
Description

The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.