Study of Genetic and Biological Factors to Assess Personal Risk and Monitor Early Recurrence of Breast, Ovarian, Colorectal, Melanoma, and Lung Cancers

What this Trial Is About

Researchers are evaluating a clinical-translational program called the PRO-ACTIVE study aimed at cancer prevention across all phasesprimary, secondary, and tertiary. The study focuses on intervening before cancer is clinically or radiologically apparent, starting with risk prediction and leading to early diagnosis of cancer or its recurrence in a subclinical phase. The study involves investigating hereditary markers, the biological and molecular environment of tumors, immunological status, and tumor microenvironment to better predict cancer risk and recurrence. This observational study includes both retrospective and prospective parts. The retrospective part selects 400 patients with breast tumors operated between 2000 and 2015 for detailed tissue and molecular analysis. The prospective part enrolls 600 patients with breast, ovarian, or colorectal cancer who undergo germline genetic testing and are classified into cohorts based on their hereditary risk. Another cohort includes 250 patients undergoing radical surgery for various advanced cancers. Blood samples and tumor tissues are collected for genetic, immune, and molecular studies throughout the study. Participants will have blood samples taken for DNA, RNA, circulating tumor cells, circulating tumor DNA, and immune population analyses. Tumor tissues will be studied using advanced sequencing methods. Researchers will monitor genetic variants not detected by standard tests and measure circulating tumor cells and DNA over a 12-month follow-up. The study will help understand cancer risk and recurrence through non-invasive monitoring and biological analysis, with participant involvement including clinical follow-ups and sample collections.

A Study of Biological, Genetic, and Constitutional Factors and Non-invasive Monitoring to Assess Personal Cancer Risks