NCT02493972

Brief Summary

This is a Multicenter prospective diagnostic study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

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

June 26, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

3.8 years

First QC Date

June 26, 2015

Last Update Submit

July 8, 2019

Conditions

Ovarian Cancer With Peritoneal Carcinosis

Keywords

ovarian cancerperitoneal carcinosismanual explorationsurgeryGelPort

Outcome Measures

Primary Outcomes (1)

  • evaluate the number of patients with or without laparotomy after evaluation of the resectability by coelioscopy and coelioscopy more manual exploration

    1 month after inclusion

Secondary Outcomes (2)

  • Number of patients with complications (eventrations, infections, pains) after manual exploration

    1 month after inclusion

  • Number of patients with parietal metastases

    1 month after inclusion

Study Arms (1)

manual exploration by GelPort

EXPERIMENTAL

manual exploration in supplement of coelioscopy before laparotomy

Procedure: GelPortProcedure: laparotomy

Interventions

GelPortPROCEDURE

Manual exploration of the peritoneal carcinosis by the system GelPort ® with calculation of peritoneal cancer index for evaluation of the resectability

manual exploration by GelPort
laparotomyPROCEDURE

laparotomy will be performed if indication confirmed by manual exploration

manual exploration by GelPort

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age Patient
  • Woman presenting a peritoneal carcinosis presumed ovarian origin
  • Coelioscopy (1st intent or recurrence) planned or performed in the last 4 weeks for laparotomy. The peritoneal cancer index of Sugarbaker must be available.
  • WHO 0 - 2
  • Membership in a social security system
  • Patient having given her written consent

You may not qualify if:

  • Male
  • Contraindication in the coelioscopy
  • Any associated medical or psychological condition which could compromise the capacity of the patient to participate in the study
  • Patient deprived of freedom, under guardianship or guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU

Amiens, France

Location

Centre Françis Baclesse

Caen, France

Location

CHU

Caen, France

Location

Institut de Cancérologie de l'Ouest

Nantes, France

Location

Centre Henri Becquerel

Rouen, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Laparotomy

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)

Surgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2015

First Posted

July 10, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 9, 2019

Record last verified: 2019-07

Locations

FR(5)