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

Launched by DANA-FARBER CANCER INSTITUTE · Jul 14, 2022

Keywords

ClinConnect Summary

The InAdvance trial is a research study aimed at understanding and improving how we can detect and prevent cancer in people who are at higher risk. This includes individuals with a family history of cancer, those who have been diagnosed with early stages of cancer, or even healthy family members of those at risk. The goal is to gather information and biological samples from participants to help identify early signs of cancer and understand what factors may lead to its development. By doing this, researchers hope to find new ways to detect cancer early and develop treatments that can stop it from progressing.

To participate in this study, individuals may need to meet certain criteria, such as having a hereditary risk for cancer or being a survivor of childhood or adult cancer with related treatment exposures. There's no age limit, and both men and women are encouraged to join. Participants can expect to provide information about their health and family history, as well as give samples for analysis. Importantly, people who have had cancer in the past can still take part in the study, and there are no restrictions based on prior treatment. This trial represents a promising step toward better cancer prevention and early detection strategies.

Gender

ALL

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.