An Integrated Genomic Approach to Assess Genetic Risk and Drug Sensitivity (NCT07555639) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
An Integrated Genomic Approach to Assess Genetic Risk and Drug Sensitivity
Italy4,000 participantsStarted 2019-11-21
Plain-language summary
National multicenter prospective study, involving the enrollment of approximately 1,500 patients with ovarian cancer, 1,500 patients with breast cancer, and 1,000 patients with colorectal cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Ovary
Newly diagnosed patients with epithelial ovarian, peritoneal, or fallopian tube tumors of any histology and stage, excluding borderline tumors, who are scheduled to undergo an invasive diagnostic or therapeutic procedure (surgery or biopsy). In the case of neoadjuvant therapy, availability of a pre-treatment biopsy sample is required.
Age \> 18 years.
Written informed consent.
Patients with recurrent disease, either untreated or treated with no more than one prior line of therapy, who are scheduled to undergo an invasive diagnostic or therapeutic procedure (surgery or biopsy), provided that paraffin-embedded tissue from the untreated primary tumor is available, not older than 2 years, and that a new pre-enrollment biopsy is feasible.
Patients in remission (identified during follow-up) who have received no more than one prior line of therapy, provided that paraffin-embedded tissue from the untreated primary tumor is available and not older than 2 years.
Breast
Triple-negative breast cancer (ER and PgR \<10% and HER2 negative: IHC 0, 1+, or 2+ with non-amplified ISH) or breast cancer diagnosed in patients younger than 40 years, who are scheduled to undergo an invasive diagnostic or therapeutic procedure (surgery or biopsy).
Eligible patients include:
Early-stage disease (neoadjuvant or adjuvant setting). In the case of neoadjuvant therapy, availability of a pre-treatment biopsy sample before chemotherapy is required.
Metastatic disease. In t…
What they're measuring
1
To validate the germline and somatic mutations with the Gersom panel.