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

National Cancer Institute, Naples300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Gynecologic Cancer

Interventions

NGS testsOTHER

This study is an observational, the patients with have an available NGS report performed in context of clinical practice or collected in clinical trials. Patients enrolled in the current study will be managed as for clinical practice and no additional genetic tests or other procedure will be required.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Istituto Nazionale Tumori, IRCCS, Fondazione G Pascale

Naples, Italy

RECRUITING

Outcomes

Primary Outcomes

The proportion of different gene alterations found with NGS tests

This percentage will be calculated within enrolled patients that have a report of NGS test at baseline

Time frame: 4years

Secondary Outcomes

Progression-free-survival (PFS)

PFS as defined by the Investigator using RECIST 1.1, as the time frame from randomization to progression or death for any cause,whichever comes first

Time frame: until progression disease (up to 4 years)

Overall survival (OS)

Overall survival (OS) will be defined as the time between first line therapy start and death from any cause

Time frame: 4 years

ORR

Overall Response Rate (ORR) will be defined as the proportion of patients achieving a complete or partial response to a given therapy.

Time frame: 4 years

Central Contacts

Clorinda Schettino, MD

CONTACT

003908117770287 c.schettino@istitutotumori.na.it

Sandro Pignata, MD

CONTACT

003908117770355 s.pignata@istitutotumori.na.it

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.