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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Gynecologic Cancer

Intervention / Treatment
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* Other: NGS tests


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A (Retrospective):<br>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. | Other: NGS tests<br>* 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.<br>|
| Cohort B (Prospective):<br>• 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. | Other: NGS tests<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Next Genaration Sequencing (NGS), Molecular profile