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Trial record 1 of 1 for:    CARPEMAN
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Interest of the Manual Exploration as a Supplement to the Coelioscopy in the Evaluation of the Resectability of Peritoneal Carcinosis (CARPEMAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02493972
Recruitment Status : Completed
First Posted : July 10, 2015
Last Update Posted : July 9, 2019
Groupement Interrégional de Recherche Clinique et d'Innovation
Information provided by (Responsible Party):
Centre Francois Baclesse

Brief Summary:
This is a Multicenter prospective diagnostic study.

Condition or disease Intervention/treatment Phase
Ovarian Cancer With Peritoneal Carcinosis Procedure: GelPort Procedure: laparotomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : September 2015
Actual Primary Completion Date : July 2019
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: manual exploration by GelPort
manual exploration in supplement of coelioscopy before laparotomy
Procedure: GelPort
Manual exploration of the peritoneal carcinosis by the system GelPort ® with calculation of peritoneal cancer index for evaluation of the resectability

Procedure: laparotomy
laparotomy will be performed if indication confirmed by manual exploration

Primary Outcome Measures :
  1. evaluate the number of patients with or without laparotomy after evaluation of the resectability by coelioscopy and coelioscopy more manual exploration [ Time Frame: 1 month after inclusion ]

Secondary Outcome Measures :
  1. Number of patients with complications (eventrations, infections, pains) after manual exploration [ Time Frame: 1 month after inclusion ]
  2. Number of patients with parietal metastases [ Time Frame: 1 month after inclusion ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02493972

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Amiens, France
Centre Françis Baclesse
Caen, France
Caen, France
Institut de Cancérologie de l'Ouest
Nantes, France
Centre Henri Becquerel
Rouen, France
Sponsors and Collaborators
Centre Francois Baclesse
Groupement Interrégional de Recherche Clinique et d'Innovation
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Responsible Party: Centre Francois Baclesse Identifier: NCT02493972    
Other Study ID Numbers: 2015-A00615-44
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Keywords provided by Centre Francois Baclesse:
ovarian cancer
peritoneal carcinosis
manual exploration
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders