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
Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY
The PRO-ACTIVE study aims to develop a clinical-translational program in the field of cancer prevention in all its phases (primary, secondary, and tertiary) to intervene before the clinical and radiological manifestation of the disease. It starts with risk prediction and leads to early diagnosis of the disease or recurrence in the subclinical phase. The PRO-ACTIVE study includes the following activities: * WP1: Integrated DNA-RNA approach for the identification of hereditary markers of predisposition to tumors * WP2: Global biological and molecular analysis of the host and tumor for the prevention and monitoring of recurrences * WP3: Analysis of the immunological status for the diagnosis of primary prevention and relapses in correlation to genetic and environmental factors * WP4: Study of the tumor microenvironment for recurrence prediction
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Italy
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
RECRUITING
Candiolo
Contact Information
Primary
Vanesa Gregorc, MD
vanesa.gregorc@ircc.it
+390119933915
Time Frame
Start Date:2024-02-01
Estimated Completion Date:2027-12-31
Participants
Target number of participants:850
Treatments
Cohort 1
600 patients known for breast cancer (N=200), ovarian cancer (N=200) and colorectal cancer (N=200) candidates for germline genetic testing in the context of an oncogenic consultation will be evaluated.
Cohort 2A
Subjects with hereditary inheritance (probands): the identification of about 10% (N=60) of probands out of 600 subjects examined (20 for pathology) is assumed
Cohort 2B
Subjects identified by genetic counseling as being at risk of being carriers of a hereditary neoplastic syndrome, not proven by genetic tests: a population of 60 subjects, 20 for each type of tumour, with similar clinical characteristics of age and phenotype compared to cohort 2A.
Cohort 2C
50 subjects for each type of tumor (colorectal, breast and ovarian cancer), negative results in diagnostic genetic analysis. In selected patients in this cohort, DNA/RNA will be analyzed for the identification of causative genetic variants in genes that have escaped routine diagnostic investigation.
Cohort 3
250 patients undergoing radical surgical treatment and with the following characteristics:~* locally advanced breast cancer with triple negative phenotype or with lobular histology (N=50);~* high-grade serous ovarian carcinoma (N=50);~* stage III melanoma (N=50);~* stage IIB and IIIA non-small cell lung cancer (N=50);~* colon cancer with lymph node involvement and vascular invasion (N=50).