RECRUITING

InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer. * The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal. * The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.

Official Title

InAdvance: Surveillance, Prevention, and Interception in a Population at Risk For Cancer

Quick Facts

Study Start:2023-04-25
Study Completion:2032-03-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05463796

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants to be included in this study include the following (note that this list is not comprehensive but gives examples of precursor conditions for each organ type):
  2. * Carriers of known or previously unrecognized pathogenic germline variants of cancer predisposing genes
  3. * Individuals with personal or family history suggestive of elevated cancer risk (this may include individuals who have negative genetic testing results or have not elected to undergo testing)
  4. * Individuals with a clinically based diagnosis of a Cancer Predisposition Syndrome (examples, neurofibromatosis, Fanconi Anemia, Ataxia-Telangiectasia)
  5. * Hereditary Cancer Prediction Model-based elevated cancer risk
  6. * Others at risk for specific cancers by virtue of exposure, obesity, gender, race and ethnicity, HPV exposure (for H\&N cancer for example), etc.
  7. * Exposed High Risk including
  8. * Childhood cancer survivors with treatment exposures associated with increased risk of cancer
  9. * Adult cancer survivors with treatment exposures associated with increased risk of cancer
  10. * Documented high level exposure to group 1 IARC carcinogens
  11. * Thoracic: individuals at risk for lung cancer including but not exclusive of the following criteria: Age \>50, Smoking history of \>15 pack years, First-degree relative history of lung cancer or COPD
  12. * alcoholic liver disease (NAFL), non-alcoholic steatohepatitis (NASH), cirrhosis
  13. * Precursor Lesions including
  14. * Breast: ductal/lobular carcinoma in situ (CIS) and atypical hyperplasia
  15. * GI: Barrett's esophagus, Pancreatic precursor lesions, colonic dysplasia/adenomata, nonalcoholic fatty liver (NAFL), nonalcoholic steatohepatitis (NASH), cirrhosis
  16. * GU: High grade prostatic epithelial neoplasia, and high-grade bladder urothelial dysplasia/carcinoma in situ,
  17. * Lung: Adenomatous hyperplasia
  18. * H\&N: high-risk oral precancerous diseases
  19. * Skin: Class II melanocytic lesions. Squamous dysplasia
  20. * Heme malignancies: CHIP, CCUS, ICUS, MGUS, SMM, SWM, MBL (spell these out), Low grade lymphomas
  21. * Thoracic: Lung nodules detected on screening CT that prompt further follow-up
  22. * GYN: STIC lesion (serous tubal intraepithelial carcinoma), Endometrial intraepithelial neoplasia, Cervical and endocervical carcinoma in situ, vulvar intraepithelial neoplasia
  23. * Pediatric histologic diagnoses sometimes associated with development of malignancy: Nephrogenic rests, benign bone lesions with risk of malignant degeneration (Giant cell tumor, osteochondroma), Spitz nevus, and others.
  24. * FAMILY MEMBERS or healthy individuals
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Jenna Beckwith, MPH
CONTACT
857-215-1892
inadvancestudy@dfci.harvard.edu
Tia Kauffman, MPH
CONTACT

Principal Investigator

Sapna Syngal, MD
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Sapna Syngal, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-25
Study Completion Date2032-03-25

Study Record Updates

Study Start Date2023-04-25
Study Completion Date2032-03-25

Terms related to this study

Keywords Provided by Researchers

  • Hereditary Risk for Cancer
  • Childhood cancer survivors
  • Adult cancer survivors
  • Precursor Lesions

Additional Relevant MeSH Terms

  • Cancer Risk
  • Cancer Predisposition Syndrome
  • Hereditary Cancer Prediction
  • Childhood Cancer Survivors
  • Adult Cancer Survivors
  • IARC Carcinogens
  • Smoking History
  • Lung Cancer
  • Ductal/Lobular Carcinoma
  • Barrett Esophagus
  • Pancreatic Precursor Lesions
  • Colonic Dysplasia/Adenomata
  • Non-Alcoholic Fatty Liver Disease
  • Non Alcoholic Steatohepatitis
  • Cirrhosis
  • High Grade Prostatic Epithelial Neoplasia
  • High-grade Bladder Urothelial Dysplasia/Carcinoma in Situ
  • Adenomatous Hyperplasia
  • High-risk Oral Precancerous Diseases
  • Melanocytic Lesion, Adult
  • Hematologic Malignancy
  • Lung; Node
  • Serous Tubal Intraepithelial Carcinoma
  • Endometrial Intraepithelial Neoplasia
  • Cervical and Endocervical Carcinoma in Situ
  • Vulvar Intraepithelial Neoplasia
  • Nephrogenic Rests
  • Benign Bone Lesions With Risk of Malignant Degeneration
  • Giant Cell Tumor
  • Osteochondroma
  • Spitz Nevus