An observational study in Gynecologic Cancer, sponsored by National Cancer Institute, Naples. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-23.
Sponsored by National Cancer Institute, Naples · Observational
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.
National Cancer Institute, Naples is the lead sponsor of 112 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients diagnosed with a gynecological cancer with an available NGS report.
Exclusion Criteria:
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
• 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
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.
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
Time frame: 4years
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
Time frame: until progression disease (up to 4 years)
Overall survival (OS)
Overall survival (OS) will be defined as the time between first line therapy start and death from any cause
Time frame: 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.
Time frame: 4 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Cancer Institute, Naples