French National Registry of Rare Peritoneal Surface Malignancies (RENAPE)

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ClinicalTrials.gov Identifier: NCT02834169

Recruitment Status : Unknown

Verified August 2017 by Hospices Civils de Lyon.
Recruitment status was: Active, not recruiting

First Posted : July 15, 2016

Last Update Posted : August 22, 2017

Sponsor:

Information provided by (Responsible Party):

Hospices Civils de Lyon

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Rare Peritoneal Surface Malignancies Pseudomyxoma Peritonei Peritoneal Mesothelioma Desmoplastic Small Round Cell Tumor Psammocarcinoma Primary Peritoneal Serous Carcinoma Diffuse Peritoneal Leiomyomatosis Appendiceal Mucinous Neoplasms	Other: Non interventional

Study Design

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Study Type :	Observational [Patient Registry]
Actual Enrollment :	2171 participants
Observational Model:	Cohort
Time Perspective:	Other
Target Follow-Up Duration:	8 Years
Official Title:	French National Registry of Rare Peritoneal Surface Malignancies (RENAPE Registry)
Study Start Date :	October 2010
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	December 2018

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Desmoplastic Small Round Cell Tumor Pseudomyxoma Peritonei Malignant Mesothelioma Intravenous Leiomyomatosis Disseminated Peritoneal Leiomyomatosis Adenocarcinoma of the Appendix Soft Tissue Sarcoma

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Prospectively or retrospectively diagnosed patients with rare peritoneal surface malignancies.

Criteria

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

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02834169

Locations

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

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

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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

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Villeneuve L, Passot G, Glehen O, Isaac S, Bibeau F, Rousset P, Gilly FN; RENAPE Network. The RENAPE observational registry: rationale and framework of the rare peritoneal tumors French patient registry. Orphanet J Rare Dis. 2017 Feb 17;12(1):37. doi: 10.1186/s13023-017-0571-y.

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Responsible Party:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT02834169 History of Changes
Other Study ID Numbers:	69HCL16_0406
First Posted:	July 15, 2016 Key Record Dates
Last Update Posted:	August 22, 2017
Last Verified:	August 2017

Keywords provided by Hospices Civils de Lyon:


Rare peritoneal surface malignancies pseudomyxoma peritonei peritoneal mesothelioma desmoplastic small round cell tumor psammocarcinoma	primary peritoneal serous carcinoma diffuse peritoneal leiomyomatosis appendiceal mucinous neoplasms registry population-based database

Additional relevant MeSH terms:

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Mesothelioma Desmoplastic Small Round Cell Tumor Cystadenocarcinoma, Serous Pseudomyxoma Peritonei Peritoneal Neoplasms Leiomyomatosis Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenoma Neoplasms, Mesothelial	Sarcoma Neoplasms, Connective and Soft Tissue Cystadenocarcinoma Adenocarcinoma Neoplasms, Cystic, Mucinous, and Serous Abdominal Neoplasms Neoplasms by Site Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Leiomyoma Neoplasms, Muscle Tissue

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