NCT05733806

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Oct 2019Feb 2030

Study Start

First participant enrolled

October 14, 2019

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Expected
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

5.2 years

First QC Date

February 8, 2023

Last Update Submit

February 21, 2023

Conditions

Gynecologic Cancer

Keywords

rare cancersgynecologic malignancies

Outcome Measures

Primary Outcomes (1)

  • Prevalence of gynecologic rare malignancies

    To describe the prevalence of gynecologic rare tumors

    5 years

Study Arms (1)

Gynecologic rare tumors

The study will include patients with rare gynecologic malignancies

Other: chemotherapy, surgery

Interventions

chemotherapy, surgeryOTHER

this is an observational prospective study, therefore no intervention is planned. Patients perform medical and surgical treatment as per standard of case.

Gynecologic rare tumors

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspatient with gynecologic cancers
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with rare gynecological malignancies

You may qualify if:

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

You may not qualify if:

  • written informed consent not provided

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ginecologia e Ostetricia, IRCCS Ospedale San Raffaele

Milan, Italy

RECRUITING

IRCCS Fondazione G Pascale

Naples, Italy

RECRUITING

MeSH Terms

Interventions

Drug TherapySurgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Francesco Perrone, MD

    IRCCS Fondazione G Pascale, Naples

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Perrone, MD

CONTACT

0039 081 1777 0276f.perrone@istitutotumori.na.it

Giorgia Mangili, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 17, 2023

Study Start

October 14, 2019

Primary Completion

January 1, 2025

Study Completion (Estimated)

February 1, 2030

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)