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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-16

Study Completion Date

2025-06-16

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.

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Detailed Description

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Conditions

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Gynecologic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A (Retrospective):

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.

NGS tests

Intervention Type OTHER

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.

Cohort B (Prospective):

• 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.

NGS tests

Intervention Type OTHER

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.

Interventions

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NGS tests

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.

Intervention Type OTHER

Eligibility Criteria

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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