Personal cancer risk testing using genetic, blood, and tumor monitoring
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
Fondazione del Piemonte per l'Oncologia · NCT07469709
This project will test whether combining genetic testing, blood-based analyses, and tumor tissue checks can identify personal cancer risk and detect early recurrence in adults with breast, ovarian, colorectal, melanoma, or certain non-small cell lung cancers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 850 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione del Piemonte per l'Oncologia (other) |
| Locations | 1 site (Candiolo, Turin) |
| Trial ID | NCT07469709 on ClinicalTrials.gov |
What this trial studies
PRO-ACTIVE is an observational program combining retrospective and prospective cohorts to build a clinical-translational prevention and early-detection pathway. The retrospective arm analyzes 400 archived breast tumor samples (200 hereditary, 200 non-hereditary) with immunohistochemistry to study angiogenesis, stromal cells, and immune infiltrates and correlate these features with prognosis. The prospective arm will enroll about 600 patients (200 each with breast, ovarian, and colorectal cancer) offered germline genetic testing and will collect blood for DNA/RNA extraction and integrated molecular profiling. Four work packages link germline DNA-RNA analysis, host/tumor molecular profiling, immune-status characterization, and tumor microenvironment study to predict personal risk and detect subclinical recurrence.
Who should consider this trial
Good fit: Adults (over 18) with breast cancer (including those meeting AIOM/BRCA testing criteria), radically resected colon cancer, ovarian carcinoma, metastatic melanoma, or stage IIB/IIIA non-small cell lung cancer who can provide consent and samples are the intended participants.
Not a fit: People under 18, those unwilling or unable to give informed consent, and patients without the listed tumor types or who cannot provide required blood or tissue samples are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could enable earlier detection of cancer or recurrence and allow prevention or monitoring strategies tailored to each patient’s genetic and molecular profile.
How similar studies have performed: Individual elements like germline BRCA testing, liquid-biopsy approaches, and tumor microenvironment analyses have shown promise, but integrating these components into a comprehensive prevention and early-monitoring program is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years; * Patients with breast cancer, including patients who meet the AIOM criteria for eligibility for BRCA testing and patients with lobular breast cancer; * Patients with radically resected colon cancer, including patients with stage III colon cancer and vascular invasion; * Patients with ovarian carcinomas; * Patients with metastatic melanoma; * Patients with stage IIB and IIIA non-small cell lung cancer. Exclusion Criteria: * Age \<18 years; * Unwillingness or inability to give informed consent
Where this trial is running
Candiolo, Turin
- Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo — Candiolo, Turin, Italy (RECRUITING)
Study contacts
- Study coordinator: Vanesa Gregorc, MD
- Email: vanesa.gregorc@ircc.it
- Phone: +390119933915
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.
Conditions: Breast Cancer, Colo-rectal Cancer, Ovarian Cancer, Melanoma, Non-Small Cell Lung Cancer