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

NCT05733793 | Unknown

• 1 other identifier: Gynger
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Keywords

Next Genaration Sequencing (NGS); Molecular profile

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression-free-survival (PFS)

  until progression disease (up to 4 years)

• Overall survival (OS)

  4 years

• ORR

  4 years

Study Arms (2)

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

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

Interventions

NGS tests 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 A (Retrospective):; Cohort B (Prospective):

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patients for which the NGS analysis has been performed of germline tissue

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

Istituto Nazionale Tumori, IRCCS, Fondazione G Pascale

Naples, 80131, Italy

RECRUITING

Related Links

• Description: Sponsor web-site for study conduction

Central Study Contacts

Clorinda Schettino, MD

CONTACT

003908117770287; c.schettino@istitutotumori.na.it

Sandro Pignata, MD

CONTACT

003908117770355; s.pignata@istitutotumori.na.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: June 16, 2021
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

IT (1)