NCT02297958

Brief Summary

Ovarian carcinoma has poor prognosis and new therapeutic strategies are required. Many patients with ovarian carcinoma showed resistance to chemotherapy. Cleaved FasL is known for induced atypical response when is binding to Fas such as avoiding apoptosis and inducing cell motility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 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

First Submitted

Initial submission to the registry

November 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 15, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2019

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

4.5 years

First QC Date

November 19, 2014

Last Update Submit

August 28, 2020

Conditions

Ovarian Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Correlation between cleaved FasL level ans neoadjuvant chemotherapy tumor response

    Main outcome is cleaved FasL level and correlation with neoadjuvant chemotherapy tumor response, evaluated during surgery.

    surgery

Secondary Outcomes (3)

  • Identification of tumoral T cells

    surgery

  • Disease Free Survival rate

    18 months after surgery

  • Overall survival rate

    18 months after surgery

Eligibility Criteria

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

Patient with ovarian carcinoma

You may qualify if:

  • \- Patient with suspicious ovarian carcinoma using clinical data, biological data (ca125) and radiological data (CT)
  • Pathological ovarian carcinoma diagnosed at pathological analysis after surgery.
  • Neo adjuvant chemotherapy

You may not qualify if:

  • no neo-adjuvant chemotherapy
  • no ovarian carcinoma at final pathological analysis
  • less than 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Gynécologie

Rennes, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms

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

Study Officials

  • Vincent Lavoue, PH

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2014

First Posted

November 21, 2014

Study Start

January 15, 2015

Primary Completion

July 27, 2019

Study Completion

July 27, 2019

Last Updated

August 31, 2020

Record last verified: 2020-08

Locations

FR(1)