French National Registry of Rare Peritoneal Surface Malignancies (RENAPE)

August 18, 2017 updated by: Hospices Civils de Lyon

French National Registry of Rare Peritoneal Surface Malignancies (RENAPE Registry)

Despite advances in the management of and changes in clinical practice, little is known about the epidemiology, patterns of care and outcomes of rare peritoneal surface malignancies patients in France.

In order to better understand the characteristics of rare peritoneal surface malignancies and to evaluate treatment strategies, the RENAPE registry aims at the collection of data from patients presenting with a rare peritoneal surface malignancy in France. Data will be entered prospectively in a specifically designed and secured web database.

All RENAPE's centres and physicians are invited to register patients with a rare peritoneal surface malignancy diagnosis and to participate to the registry. Data will be evaluated within regular time frames, focusing on types of rare peritoneal surface malignancies, treatment modalities and patient outcomes (e.g. survival, recurrence), thereby contributing to the better understanding of these rare cancers.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2171

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49100
        • Institut de Cancerologie de l'Ouest - Paul Papin
      • Besancon, France, 25030
        • CHU Jean Minjoz
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Caen, France, 14076
        • Centre François Baclesse
      • Clermont-ferrand, France, 63011
        • Centre Jean Perrin
      • Clermont-ferrand, France, 63003
        • CHU Estaing
      • Colombes, France, 92700
        • AP-HP Louis Mourier
      • Dijon, France, 21079
        • CHU Bocage
      • La Tronche, France, 38700
        • CHU A. Michallon
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lille, France, 59037
        • CHRU Claude Huriez
      • Lyon, France, 69008
        • Centre Léon Bérard
      • Marseille, France, 13273
        • Institut Paoli Calmettes
      • Marseille, France, 13385
        • Hôpital La Timone
      • Montpellier, France, 34298
        • Institut du Cancer Montpellier
      • Nantes, France, 44093
        • CHU Nantes Hôtel-Dieu
      • Nice, France, 06200
        • CHU L'Archet II
      • Paris, France, 75005
        • Institut Curie
      • Paris, France, 75012
        • AP-HP St Antoine
      • Paris, France, 75013
        • AP-HP La Pitié-Salpétrière
      • Paris Cedex 10, France, 75475
        • AP-HP Lariboisiere
      • Paris Cedex 15, France, 75908
        • AP-HP Hôpital Européen Georges Pompidou
      • Pierre-benite, France, 69495
        • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet,
      • Poitiers, France, 86021
        • CHU Poitiers
      • Reims, France, 51092
        • Hopital Robert Debre
      • Rouen, France, ROUEN
        • Chu Charles Nicolle
      • Saint Herblain, France, 44805
        • Institut Cancérologie de l'Ouest - René Gauducheau
      • St Etienne, France, 42055
        • CHU Nord
      • Strasbourg, France, 67098
        • CHRU Hautepierre
      • Toulouse, France, 31059
        • Hopital Purpan
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Vandoeuvre-les-nancy, France, 54519
        • Institut de Cancérologie de Lorraine
      • Villejuif, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Prospectively or retrospectively diagnosed patients with rare peritoneal surface malignancies.

Description

Inclusion Criteria:

  • Patients are eligible if they have a histologically proven rare peritoneal surface malignancy.

Exclusion Criteria:

  • Histological diagnostic of peritoneal surface malignancy not confirmed
  • Expected clinical follow up data not available

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pseudomyxoma peritonei
Data from pseudomyxoma peritonei cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).
Other: Non interventional
Data collection
peritoneal mesothelioma
Data from peritoneal mesothelioma cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).
Other: Non interventional
Data collection
desmoplastic small round cell tumor
Data from desmoplastic small round cell tumor cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).
Other: Non interventional
Data collection
psammocarcinoma
Data from primary peritoneal serous carcinoma cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).
Other: Non interventional
Data collection
primary peritoneal serous carcinoma
Data from primary peritoneal serous carcinoma cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).
Other: Non interventional
Data collection
diffuse peritoneal leiomyomatosis
Data from diffuse peritoneal leiomyomatosis cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).
Other: Non interventional
Data collection
appendiceal mucinous neoplasms
Data from appendiceal mucinous neoplasms cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).
Other: Non interventional
Data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of rare peritoneal surface malignancies
Time Frame: year 5
Collect detailed clinical and histological diagnosis for estimating annual incidence rate
year 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of specific treatment strategies
Time Frame: year 5
Collect detailed therapeutic strategies (surgical procedure, chemotherapy, etc.) on patients with rare peritoneal surface malignancies
year 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: François-Noël GILLY, Prof, Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet, PIERRE-BENITE, FRANCE, 69495

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (ESTIMATE)

July 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 18, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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