Study on Gynecological Rare Cancers (MITO9B)

February 21, 2023 updated by: National Cancer Institute, Naples

Prospective, Multicenter, Observational Study on Rare Gynecological Cancers

This is a prospective, observational, multicenter study on gynecological rare tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Giorgia Mangili, MD

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with rare gynecological malignancies

Description

Inclusion Criteria:

  • rare gynecological malignancies
  • written informed consent
  • patient fit for follow-up

Exclusion criteria

-written informed consent not provided

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gynecologic rare tumors
The study will include patients with rare gynecologic malignancies
Other: chemotherapy, surgery
this is an observational prospective study, therefore no intervention is planned. Patients perform medical and surgical treatment as per standard of case.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of gynecologic rare malignancies
Time Frame: 5 years
To describe the prevalence of gynecologic rare tumors
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Investigators

  • Principal Investigator: Francesco Perrone, MD, IRCCS Fondazione G Pascale, Naples

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2019

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

February 1, 2030

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MITO 9B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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