Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All patients diagnosed with a gynecological cancer with an available NGS report.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clorinda Schettino, MD | Contact | 003908117770287 | c.schettino@istitutotumori.na.it | |
| Sandro Pignata, MD | Contact | 003908117770355 | s.pignata@istitutotumori.na.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Nazionale Tumori, IRCCS, Fondazione G Pascale | Recruiting | Naples | 80131 | Italy |
Not provided
| Label | URL |
|---|---|
| Description: Sponsor web-site for study conduction | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |