Study of Predictive Factors of Chemoresistance in Ovarian... | NCT02878122

Studies
Study of Predictive Factors of Chemoresistance in Ovarian Cancer

NCT02878122

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Aug 17, 2021Actual

Enrollment

13Actual

Phase

Not provided

Conditions

Ovarian Cancer

Interventions

Cancer treatment

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

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Mar 2020Actual

Completion Date

Mar 2020Actual

First Submitted Date

Aug 22, 2016

First Submission Date that Met QC Criteria

Aug 24, 2016

First Posted Date

Aug 25, 2016Estimated

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

Aug 16, 2021

Last Update Posted Date

Aug 17, 2021Actual

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

Description Module

Brief Summary

Epithelial ovarian cancer (EOC) has a poor prognosis. EOC management requires debulking surgery and chemotherapy based on taxol and carboplatine. Initial response is often good, but most often a recurrence occurred in the first 18 months. Early recurrence signs chemoresistance and palliative treatment. The study of predictive clinical or biological factors is required to adapt therapeutic and develop new treatments.

Detailed Description

Not provided

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

Retention

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with epithelial ovarian cancer		Cancer treatment	Procedure: Cancer treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cancer treatment	Procedure	Chemotherapy and laparoscopic surgery	Patients with epithelial ovarian cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Chemoresistance defined by clinical recurrence		6 months after the end of chemotherapy
Chemoresistance defined by biological recurrence		6 months after the end of chemotherapy
Chemoresistance defined by radiological recurrence		6 months after the end of chemotherapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient > 18 years of age
patient with histological proven epithelial ovarian cancer

Exclusion Criteria:

patients who can not give their own consent
patients without ovarian cancer

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

Patients with epithelial ovarian cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
LAVOUE Vincent, Pr	Rennes University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LAVOUE		Rennes			France

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

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian 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

Intervention Browse Module

MeSH Terms

ID	Term
D024221	Antineoplastic Protocols
C053518	CP protocol

Ancestor Terms

ID	Term
D002985	Clinical Protocols
D013812	Therapeutics
D004358	Drug Therapy
D016020	Epidemiologic Study Characteristics

Browse Leaves

Not provided

Browse Branches

Not provided