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

Gynecologic Cancer Clinical Trial

— GYNGER  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05733793
• Other study ID #: Gynger
• Status: Recruiting
• Start date: June 16, 2021
• Est. completion date: June 16, 2025

Study information

• Verified date: February 2023
• Source: National Cancer Institute, Naples
• Contact: Clorinda Schettino, MD
• Phone: 003908117770287
• Email: c.schettino[@]istitutotumori.na.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 16, 2025
• Est. primary completion date: June 16, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

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.

Locations

Country	Name	City	State
Italy	Istituto Nazionale Tumori, IRCCS, Fondazione G Pascale	Naples

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Overall survival (OS)	Overall survival (OS) will be defined as the time between first line therapy start and death from any cause	4 years
Secondary	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

External Links

•   Description: Sponsor web-site for study conduction