Gynecologic Cancer
Conditions
Keywords
Next Genaration Sequencing (NGS), Molecular profile
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.
Interventions
OTHERNGS 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.
Sponsors
National Cancer Institute, Naples
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of different gene alterations found with NGS tests | 4years | This percentage will be calculated within enrolled patients that have a report of NGS test at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 4 years | Overall survival (OS) will be defined as the time between first line therapy start and death from any cause |
| Progression-free-survival (PFS) | until progression disease (up to 4 years) | 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 |
| ORR | 4 years | Overall Response Rate (ORR) will be defined as the proportion of patients achieving a complete or partial response to a given therapy. |
Countries
Italy
Contacts
Primary ContactClorinda Schettino, MD
Backup ContactSandro Pignata, MD
Outcome results
None listed