Analyzing gene profiles in gynecological cancer patients
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.
This study is looking at the gene profiles of Italian women with gynecological cancers to see how these genetic factors relate to their health and treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | National Cancer Institute, Naples Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT05733793 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the gene profiles of Italian patients with gynecological cancers by centralizing Next Generation Sequencing (NGS) reports from clinical practice and trials. It includes both a retrospective and a prospective cohort to correlate molecular data with clinical and pathological features. The study focuses on various types of gynecological malignancies, including ovarian, uterine, and vulvar-vaginal cancers. By gathering and analyzing this data, the study seeks to enhance understanding of the genetic factors influencing these cancers.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older diagnosed with a gynecological malignancy who have available NGS reports.
Not a fit: Patients whose NGS analysis has been performed on germline tissue will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved personalized treatment strategies for patients with gynecological cancers based on their molecular profiles.
How similar studies have performed: Other studies utilizing NGS to analyze cancer profiles have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Naples
- Istituto Nazionale Tumori, IRCCS, Fondazione G Pascale — Naples, Italy (Recruiting)
Study contacts
- Study coordinator: Clorinda Schettino, MD
- Email: c.schettino@istitutotumori.na.it
- Phone: 003908117770287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.