NCT05463796 InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
| NCT ID | NCT05463796 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Cancer Risk |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2023-04-25 |
| Primary Completion | 2027-03-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2023-04-25 with a primary completion date of 2027-03-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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): 1-Hereditary risk for cancer including * Carriers of known or previously unrecognized pathogenic germline variants of cancer predisposing genes * 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) * Individuals with a clinically based diagnosis of a Cancer Predisposition Syndrome (examples, neurofibromatosis, Fanconi Anemia, Ataxia-Telangiectasia) * Hereditary Cancer Prediction Model-based elevated cancer risk * Others at risk for specific cancers by virtue of exposure, obesity, gender, race and ethnicity, HPV exposure (for H\&N cancer for example), etc. * Exposed High Risk including * Childhood cancer survivors with treatment exposures associated with increased risk of cancer * Adult cancer survivors with treatment exposures associated with increased risk of cancer * Documented high level exposure to group 1 IARC carcinogens * 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 * alcoholic liver disease (NAFL), non-alcoholic steatohepatitis (NASH), cirrhosis * Precursor Lesions including * Breast: ductal/lobular carcinoma in situ (CIS) and atypical hyperplasia * GI: Barrett's esophagus, Pancreatic precursor lesions, colonic dysplasia/adenomata, nonalcoholic fatty liver (NAFL), nonalcoholic steatohepatitis (NASH), cirrhosis * GU: High grade prostatic epithelial neoplasia, and high-grade bladder urothelial dysplasia/carcinoma in situ, * Lung: Adenomatous hyperplasia * H\&N: high-risk oral precancerous diseases * Skin: Class II melanocytic lesions. Squamous dysplasia * Heme malignancies: CHIP, CCUS, ICUS, MGUS, SMM, SWM, MBL (spell these out), Low grade lymphomas * Thoracic: Lung nodules detected on screening CT that prompt further follow-up * GYN: STIC lesion (serous tubal intraepithelial carcinoma), Endometrial intraepithelial neoplasia, Cervical and endocervical carcinoma in situ, vulvar intraepithelial neoplasia * 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. * FAMILY MEMBERS or healthy individuals Exclusion Criteria: There are no exclusion criteria for the study. Note: Patients with prior cancer history are allowed to participate. Patients with prior history of cancer or non-metastatic localized cancers (such as skin cancer or localized prostate cancer) are allowed to be enrolled. Patients enrolled in clinical trials or receiving therapy for precursor diseases are NOT excluded from this study.
Contact & Investigator
Sapna Syngal, MD
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT05463796 clinical trial?
This trial is open to participants of all sexes, studying Cancer Risk. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05463796 currently recruiting?
Yes, NCT05463796 is actively recruiting participants. Contact the research team at inadvancestudy@dfci.harvard.edu for enrollment information.
Where is the NCT05463796 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05463796 clinical trial?
NCT05463796 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Sapna Syngal, MD at Dana-Farber Cancer Institute. The trial plans to enroll 5,000 participants.
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