Study on Gynecological Rare Cancers | NCT05733806

Studies
Study on Gynecological Rare Cancers

NCT05733806

Sponsor

National Cancer Institute, Naples

Status

Recruiting

Last Update Posted

Feb 23, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Gynecologic Cancer

Interventions

chemotherapy, surgery

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 14, 2019Actual

Primary Completion Date

Jan 1, 2025Estimated

Completion Date

Feb 1, 2030Estimated

First Submitted Date

Feb 8, 2023

First Submission Date that Met QC Criteria

Feb 8, 2023

First Posted Date

Feb 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2023

Last Update Posted Date

Feb 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gynecologic rare tumors		The study will include patients with rare gynecologic malignancies	Other: chemotherapy, surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
chemotherapy, surgery	Other	this is an observational prospective study, therefore no intervention is planned. Patients perform medical and surgical treatment as per standard of case.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion criteria

-written informed consent not provided

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

patient with gynecologic cancers

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with rare gynecological malignancies

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Francesco Perrone, MD	Contact	0039 081 1777 0276		f.perrone@istitutotumori.na.it
Giorgia Mangili, MD	Contact

Overall Officials

Name	Affiliation	Role
Francesco Perrone, MD	IRCCS Fondazione G Pascale, Naples	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ginecologia e Ostetricia, IRCCS Ospedale San Raffaele	Recruiting	Milan			Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004358	Drug Therapy
D013514	Surgical Procedures, Operative

Ancestor Terms

ID	Term
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided