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Trial Title:
Molecular Data and Their Correlations With Clinical Outcomes in Gynecological Cancer Patients.
NCT ID:
NCT05733793
Condition:
Gynecologic Cancer
Conditions: Keywords:
Next Genaration Sequencing (NGS)
Molecular profile
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
NGS tests
Description:
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.
Arm group label:
Cohort A (Retrospective):
Arm group label:
Cohort B (Prospective):
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.
Criteria for eligibility:
Study pop:
All patients diagnosed with a gynecological cancer with an available NGS report.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Istituto Nazionale Tumori, IRCCS, Fondazione G Pascale
Address:
City:
Naples
Zip:
80131
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Sandro Pignata, MD, PhD
Phone:
003908117770755
Email:
s.pignata@istitutotumori.na.it
Contact backup:
Last name:
Clorinda Schettino, MD
Phone:
003908117770287
Email:
c.schettino@istitutotumori.na.it
Investigator:
Last name:
Sandro Pignata, MD, PhD
Email:
Principal Investigator
Start date:
June 16, 2021
Completion date:
June 16, 2025
Lead sponsor:
Agency:
National Cancer Institute, Naples
Agency class:
Other
Source:
National Cancer Institute, Naples
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05733793
https://usc.istitutotumori.na.it
