Predictive Clinical and Biological Parameters in Gynecolo... | NCT01977274

Studies
Predictive Clinical and Biological Parameters in Gynecological Cancer

NCT01977274

Sponsor

Institut Paoli-Calmettes

Status

Active, not recruiting

Last Update Posted

Mar 31, 2026Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Ovarian Cancer
Endometrium Cancer
Cervix Cancer

Interventions

gynecological cancer

Countries

France

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

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Dec 2033Estimated

Completion Date

Dec 2035Estimated

First Submitted Date

Oct 30, 2013

First Submission Date that Met QC Criteria

Oct 30, 2013

First Posted Date

Nov 6, 2013Estimated

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

Mar 30, 2026

Last Update Posted Date

Mar 31, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
gynecological cancer	Experimental	blood and tumor samples	Other: gynecological cancer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gynecological cancer	Other	blood and tumor samples	gynecological cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
molecular alteration in gynecological cancer	gene expression level	average of 4 weeks after diagnosis

Secondary Outcomes

Measure	Description	Time Frame
relation between molecular alteration and clinical and histological characteristics	hazard ratio between molecular alteration and clinico-histological characteristics	up to 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

gynecological cancer suspicion
age > 18
signed informed consent

Exclusion Criteria:

- emergency

Exclusion criteria after histological exam Any diagnosis that is not a gynecological cancer (ovarian, cervix, endometrium).

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Paoli Calmettes		Marseille		13 009	France

Label	URL
official web site of the sponsor	View source

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms
D016889	Endometrial Neoplasms
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided