Gynecologic CancerGYNGERNCT05733793
Molecular Data and Their Correlations With Clinical Outcomes in Gynecological Cancer Patients.
An observational study of Gynecologic Cancer, run by National Cancer Institute, Naples at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- NGS tests
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jun 2021to 16 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with a gynecological cancer with an available NGS report.
Who may be able to join
- Signed informed consent form;
- Female sex;
- Age ≥18 years;
- Diagnosis of a gynecological malignancy (ovarian cancer, uterine cancer, vulvar-vaginal cancer, gestational trophoblastic tumor);
- 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
Who cannot join
- Patients for which the NGS analysis has been performed of germline tissue
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Nazionale Tumori, IRCCS, Fondazione G Pascale
Naples, 80131
Sandro Pignata, MD, PhD, 003908117770755, s.pignata@istitutotumori.na.it
Clorinda Schettino, MD, 003908117770287, c.schettino@istitutotumori.na.it
About this study
Official title: 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.
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.
- Conditions
- Gynecologic Cancer
- Being tested
- NGS tests
- Keywords
- Next Genaration Sequencing (NGS), Molecular profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGS testsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: NGS tests | |
| 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. Receives: Other: NGS tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4years
Secondary outcomes (3)
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
Measured: 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
Measured: 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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start16 Jun 2021
- Primary completion16 Jun 2025 (estimated)
- Study completion16 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733793
- Sponsor's protocol ID
- Gynger
- Acronym
- GYNGER
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05733793
- Acronym / sponsor ID
- GYNGER / Gynger
- Conditions
- Gynecologic Cancer
- Keywords
- Next Genaration Sequencing (NGS), Molecular profile
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 16 Jun 2025 (estimated)
- Study completion
- 16 Jun 2025 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (Retrospective): | – | Other: NGS testsCohort 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): | – | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with a gynecological cancer with an available NGS report.
Key inclusion criteria (5 listed)
- Signed informed consent form;
- Female sex;
- Age ≥18 years;
- Diagnosis of a gynecological malignancy (ovarian cancer, uterine cancer, vulvar-vaginal cancer, gestational trophoblastic tumor);
- 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
Key exclusion criteria (1 listed)
- Patients for which the NGS analysis has been performed of germline tissue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NGS testsThis 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. | Other | Cohort A (Retrospective):, Cohort B (Prospective): |
Primary outcome
The proportion of different gene alterations found with NGS tests
Time frame: 4years
This percentage will be calculated within enrolled patients that have a report of NGS test at baseline
3 secondary outcomes
Progression-free-survival (PFS)
Time frame: until progression disease (up to 4 years)
Overall survival (OS)
Time frame: 4 years
ORR
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Description: Sponsor web-site for study conductionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer, run by National Cancer Institute, Naples at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clorinda Schettino, MD (003908117770287, c.schettino@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of different gene alterations found with NGS tests (time frame: 4years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.