Study of the Impact on Survival of a Paradigm Shift in th... | NCT06907771

Studies
Study of the Impact on Survival of a Paradigm Shift in the Therapeutic Strategy of Patients With Advanced Ovarian Cancer

NCT06907771

Sponsor

University Hospital, Strasbourg, France

Status

Recruiting

Last Update Posted

Apr 2, 2025Actual

Enrollment

130Estimated

Phase

Not provided

Conditions

Ovarian Cancer

Interventions

Not provided

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 2025

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

Apr 22, 2024Actual

Primary Completion Date

Dec 22, 2025Estimated

Completion Date

Dec 22, 2025Estimated

First Submitted Date

Mar 26, 2025

First Submission Date that Met QC Criteria

Mar 26, 2025

First Posted Date

Apr 2, 2025Actual

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 26, 2025

Last Update Posted Date

Apr 2, 2025Actual

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

Ovarian cancer is the 8th leading cause of cancer-related death in women. Its prognosis is poor, with diagnosis often made at an advanced stage.

Patient management has evolved in recent years with more radical surgeries and the introduction of maintenance treatment following neoadjuvant chemotherapy.

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

No data available

No data is available for this block.

Enrollment

130Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Study of progression-free survival at 36 months		At 36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patient (≥18 years old)
Operated on at the HUS between January 1, 2010 and December 31, 2022
Having undergone primary or interval cytoreductive surgery
Suffering from stage FIGO IIIC or IV high-grade serous carcinoma of ovarian origin

Exclusion Criteria:

Patiente ayant exprimé son opposition à la réutilisation de ses données à des fins de recherches scientifiques.
Autres types histologiques de cancer de l'ovaire
Stades de la maladie FIGO I, II, IIIA et IIIC
Chirurgie de clôture.

Accepts Healthy Volunteers

Not provided

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

Adult patient (≥18 years old) having undergone primary or interval cytoreductive surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lise LECOINTRE, MD	Contact	33 3 88 12 75 10		lise.lecointre@chu-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Gynécologique et d'Obstétrique - CHU de Strasbourg - France	Recruiting	Strasbourg			France

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