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

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.

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 Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Other: NGS tests

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Clorinda Schettino, MD; Phone Number: 003908117770287; Email: c.schettino@istitutotumori.na.it
• Study Contact Backup: Name: Sandro Pignata, MD; Phone Number: 003908117770355; Email: s.pignata@istitutotumori.na.it

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • Istituto Nazionale Tumori, IRCCS, Fondazione G Pascale
    • Principal Investigator: Sandro Pignata, MD, PhD
    • Contact: Clorinda Schettino, MD; Phone Number: 003908117770287; Email: c.schettino@istitutotumori.na.it
    • Contact: Sandro Pignata, MD, PhD; Phone Number: 003908117770755; Email: s.pignata@istitutotumori.na.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with a gynecological cancer with an available NGS report.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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.
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.	Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Cancer Institute, Naples

Publications and helpful links

Helpful Links

• Description: Sponsor web-site for study conduction

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Anticipated): June 16, 2025
• Study Completion (Anticipated): June 16, 2025

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Molecular profile; Next Genaration Sequencing (NGS)
• Other Study ID Numbers: Gynger

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No