Gynecologic CancerMITO9BNCT05733806
Study on Gynecological Rare Cancers
An observational study of Gynecologic Cancer, run by National Cancer Institute, Naples at 2 sites in Italy.
Trial summary
This is a prospective, observational, multicenter study on gynecological rare tumors. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- chemotherapy, surgery
- How many people
- 500 participants
- Where
- 2 sitesItaly
- Study dates
- 14 Oct 2019to 1 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with rare gynecological malignancies
Who may be able to join
- rare gynecological malignancies
- written informed consent
- patient fit for follow-up
Who cannot join
- -written informed consent not provided
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Giorgia Mangili, MD contact
Italy2 sites, 2 recruiting
- Recruiting
Ginecologia e Ostetricia, IRCCS Ospedale San Raffaele
Milan
Giorgia Mangili, MD, mangili.giorgia@hsr.it
- Recruiting
IRCCS Fondazione G Pascale
Naples
Sandr Pignata, MD, s.pignata@istitutotumori.na.it
About this study
Official title: Prospective, Multicenter, Observational Study on Rare Gynecological Cancers
This is a prospective, observational, multicenter study on gynecological rare tumors.
Read the detailed description
This is a prospective registry aimed to better understand prognosis, clinical and pathological features, management of this rare cancer conditions for improving standard of care.
- Conditions
- Gynecologic Cancer
- Being tested
- chemotherapy, surgery
- Keywords
- rare cancers, gynecologic malignancies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapy, surgeryOther
this is an observational prospective study, therefore no intervention is planned. Patients perform medical and surgical treatment as per standard of case.
| Study group | Role | What they receive |
|---|---|---|
| Gynecologic rare tumors | The study will include patients with rare gynecologic malignancies Receives: Other: chemotherapy, surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of gynecologic rare malignancies
To describe the prevalence of gynecologic rare tumors
Measured: 5 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 start14 Oct 2019
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2030 (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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Perrone, MD, Principal investigator, IRCCS Fondazione G Pascale, Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733806
- Sponsor's protocol ID
- MITO 9B
- Acronym
- MITO9B
- 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
- Individual data sharing
- 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
- Prospective, Multicenter, Observational Study on Rare Gynecological Cancers
- ClinicalTrials.gov ID
- NCT05733806
- Acronym / sponsor ID
- MITO9B / MITO 9B
- Conditions
- Gynecologic Cancer
- Keywords
- rare cancers, gynecologic malignancies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2030 (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.
This is a prospective, observational, multicenter study on gynecological rare tumors.
Detailed description
This is a prospective registry aimed to better understand prognosis, clinical and pathological features, management of this rare cancer conditions for improving standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gynecologic rare tumors | – | Other: chemotherapy, surgeryThe study will include patients with rare gynecologic malignancies |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with rare gynecological malignancies
Key inclusion criteria (3 listed)
- rare gynecological malignancies
- written informed consent
- patient fit for follow-up
Key exclusion criteria (1 listed)
- -written informed consent not provided
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 |
|---|---|---|
| chemotherapy, surgerythis is an observational prospective study, therefore no intervention is planned. Patients perform medical and surgical treatment as per standard of case. | Other | Gynecologic rare tumors |
Primary outcome
Prevalence of gynecologic rare malignancies
Time frame: 5 years
To describe the prevalence of gynecologic rare tumors
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Giorgia Mangili, MD contact
Francesco Perrone, MD principal investigator
IRCCS Fondazione G Pascale, Naples
2 sites 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 2 sites 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 3 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: looking for participants now, 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 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Perrone, MD (0039 081 1777 0276, f.perrone@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of gynecologic rare malignancies (time frame: 5 years). 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.