Molecular Data and Their Correlations With Clinical Outcomes in Gynecological Cancer Patients. (GYNGER)

National Cancer Institute, Naples

Status: Enrolling

Conditions: Gynecologic Cancer

Treatments: Other: NGS tests

Study type: Observational

Funder types: Other

Identifiers

NCT05733793

Gynger

Details and patient eligibility

About

Gynger is a no profit, observational study, composed of a retrospective cohort (A) and a prospective cohort (B). The primary aim of this trial is to describe gene profile of Italian gynecological cancers patients, through the centralization of NGS reports performed in clinical practice or collected in clinical trials, and to correlation them with clinical and pathologic features.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent form;
2. Female sex;
3. Age ≥18 years;
4. Diagnosis of a gynecological malignancy (ovarian cancer, uterine cancer, vulvar-vaginal cancer, gestational trophoblastic tumor);
5. Availability of NGS report performed on solid tumor tissue from primary or recurrent disease or liquid biopsy; data from NGS assays both in-house (academic test) and commercials can be used regardless of the number of genes analyzed

Exclusion criteria

• Patients for which the NGS analysis has been performed of germline tissue

Trial design

300 participants in 2 patient groups

Cohort A (Retrospective):

Description:

Cohort A (Retrospective): • All consecutive patients diagnosed with gynecological malignancies who have performed an NGS analysis on tumor sample as for clinical practice or as part of a clinical study from the January 1st 2015 until the date in which the study is approved by the local ethical committee (Investigator is allowed to enroll patients) will be enrolled.

Treatment:

Other: NGS tests

Cohort B (Prospective):

Description:

• All consecutive patients diagnosed with a gynecological malignancy who perform an NGS analysis on tumor sample as for clinical practice or as part of a clinical practice from the date in which the study is approved by the local ethical committee (Investigator is allowed to enroll patients) until 1st January 2025.

Treatment:

Other: NGS tests