NCT02878122

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

5 years

First QC Date

August 22, 2016

Last Update Submit

August 16, 2021

Conditions

Ovarian Cancer

Keywords

ovarian cancerchemo resistancepredictive factorscohort studybio bank

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Patients with epithelial ovarian cancer

Cancer treatment

Procedure: Cancer treatment

Interventions

Cancer treatmentPROCEDURE

Chemotherapy and laparoscopic surgery

Also known as: Carboplatin, Taxol
Patients with epithelial ovarian cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with epithelial ovarian cancer

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LAVOUE

Rennes, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

surgical sampling, blood plasma

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Antineoplastic ProtocolsCP protocol

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Clinical ProtocolsTherapeuticsDrug TherapyEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • LAVOUE Vincent, Pr

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 25, 2016

Study Start

March 1, 2015

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

August 17, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)