NCT05733793RecruitingNot Applicable
A Retrospective-prospective, Multicenter, Observational Study Aimed to Record Molecular Data and to Explore Their Correlations With Clinical Outcomes in Gynecological Cancer Patients. The MITO GYNecological Cancers GEnetic Profile Registry (GYNGER) Study.
National Cancer Institute, Naples1 site in 1 country300 target enrollmentStarted: June 16, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- The proportion of different gene alterations found with NGS tests
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed informed consent form;
- •Female sex;
- •Age ≥18 years;
- •Diagnosis of a gynecological malignancy (ovarian cancer, uterine cancer, vulvar-vaginal cancer, gestational trophoblastic tumor);
- •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
Outcomes
Primary Outcomes
The proportion of different gene alterations found with NGS tests
Time Frame: 4years
This percentage will be calculated within enrolled patients that have a report of NGS test at baseline
Secondary Outcomes
- Progression-free-survival (PFS)(until progression disease (up to 4 years))
- Overall survival (OS)(4 years)
- ORR(4 years)
Investigators
Study Sites (1)
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