Collecting data to predict cancer risk in at-risk populations
InAdvance: Surveillance, Prevention, and Interception in a Population at Risk For Cancer
This study is trying to collect samples and health information from people at higher risk of cancer to see if they can find signs that help predict cancer early on.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05463796 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather specimens and clinical information from individuals at increased risk of developing cancer, including those with precursor lesions or a family history of cancer. By analyzing blood, urine, and other biological samples, the study seeks to identify clinical, molecular, and pathological changes that could predict early cancer development and progression. The ultimate goal is to discover novel markers for early detection and risk stratification, potentially leading to new therapeutic approaches to intercept cancer progression.
Who should consider this trial
Good fit: Ideal candidates include individuals with hereditary cancer predisposition, childhood cancer survivors, and those with a family history of cancer or precursor lesions.
Not a fit: Patients without any known risk factors for cancer or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and prevention strategies for individuals at high risk of cancer.
How similar studies have performed: Other studies focusing on early detection and risk stratification in cancer have shown promise, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Sapna Syngal, MD — Dana-Farber Cancer Institute
- Study coordinator: Jenna Beckwith, MPH
- Email: inadvancestudy@dfci.harvard.edu
- Phone: 857-215-1892
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.