Actively Recruiting
A Platform for Assessing Personal Risk of Developing or Recurring of Cancer: Study of Biological, Genetic, and Constitutional Factors and Non-invasive Monitoring of Subclinical Recurrences With Therapeutic Impact
Led by Fondazione del Piemonte per l'Oncologia · Updated on 2026-03-13
850
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a clinical-translational program called the PRO-ACTIVE study aimed at cancer prevention across all phases—primary, 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.
CONDITIONS
Brief Title
A Study of Biological, Genetic, and Constitutional Factors and Non-invasive Monitoring to Assess Personal Cancer Risks
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Diagnosed with breast cancer, including those eligible for BRCA testing and lobular breast cancer
- Diagnosed with radically resected colon cancer, including stage III with vascular invasion
- Diagnosed with ovarian carcinoma
- Diagnosed with metastatic melanoma
- Diagnosed with stage IIB or IIIA non-small cell lung cancer
You will not qualify if you...
- Age under 18 years
- Unwillingness or inability to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during oncogenetics consultation for consent and eligibility
Duration - Up to the time of surgery or initial treatment
Participants undergo germline genetic testing and blood sampling to analyze genetic variants and circulating tumor markers.
1 visit for blood sampling and genetic testing before surgery
Duration - Duration of surgical treatment and immediate recovery
Participants in specific cohorts undergo radical surgical treatment with collection of tumor tissue for further analysis.
1 surgical procedure visit
Duration - Up to 12 months after enrollment
Participants are monitored with blood draws for circulating tumor DNA, circulating tumor cells, and immune population studies up to 12 months after enrollment.
Multiple blood sampling visits during follow-up over 12 months
Trial Site Locations
Total: 1 location
1
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
Candiolo, Turin, Italy, 10060
Actively Recruiting
Research Team
V
Vanesa Gregorc, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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