Studying genetic and biological factors to assess personal cancer risk and recurrence

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with breast, colon, ovarian, melanoma or non-small cell lung cancer. It studies personal cancer risk and early signs of recurrence.

Age

Over 18 years

Sex

All sexes

Disease stage

Breast cancer, including lobular breast cancer and people who meet the AIOM criteria for BRCA testing. Radically resected colon cancer, including stage III with vascular invasion. Ovarian carcinoma. Metastatic melanoma. Non-small cell lung cancer, stage IIB and IIIA.

Earlier treatment

Colon cancer must have been radically resected (removed by surgery).

Main reasons for not taking part

• Under 18 years of age
• Unwilling or unable to give informed consent

The registry criteria, word for word

What the trial wants to find out

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 5 groups in the trial

• 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).