NCT02834169

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,171

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Longer than P75 for all trials

Geographic Reach
1 country

33 active sites

Status
unknown

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

Study Start

First participant enrolled

October 1, 2010

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

8.2 years

First QC Date

June 30, 2016

Last Update Submit

August 18, 2017

Conditions

Keywords

Rare peritoneal surface malignanciespseudomyxoma peritoneiperitoneal mesotheliomadesmoplastic small round cell tumorpsammocarcinomaprimary peritoneal serous carcinomadiffuse peritoneal leiomyomatosisappendiceal mucinous neoplasmsregistrypopulation-based database

Outcome Measures

Primary Outcomes (1)

  • Incidence of rare peritoneal surface malignancies

    Collect detailed clinical and histological diagnosis for estimating annual incidence rate

    year 5

Secondary Outcomes (1)

  • Impact of specific treatment strategies

    year 5

Study Arms (7)

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

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

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

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

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

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

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

Interventions

Data collection

appendiceal mucinous neoplasmsdesmoplastic small round cell tumordiffuse peritoneal leiomyomatosisperitoneal mesotheliomaprimary peritoneal serous carcinomapsammocarcinomapseudomyxoma peritonei

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospectively or retrospectively diagnosed patients with rare peritoneal surface malignancies.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Institut de Cancérologie de l'Ouest - Paul Papin

Angers, 49100, France

Location

CHU Jean Minjoz

Besançon, 25030, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Centre François Baclesse

Caen, 14076, France

Location

CHU Estaing

Clermont-Ferrand, 63003, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

AP-HP Louis MOURIER

Colombes, 92700, France

Location

CHU Bocage

Dijon, 21079, France

Location

CHU A. Michallon

La Tronche, 38700, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

CHRU Claude Huriez

Lille, 59037, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Hôpital La Timône

Marseille, 13385, France

Location

Institut du Cancer Montpellier

Montpellier, 34298, France

Location

CHU Nantes Hôtel-Dieu

Nantes, 44093, France

Location

CHU L'Archet II

Nice, 06200, France

Location

Institut Curie

Paris, 75005, France

Location

AP-HP St Antoine

Paris, 75012, France

Location

AP-HP La Pitié-Salpêtrière

Paris, 75013, France

Location

AP-HP Lariboisière

Paris, 75475, France

Location

AP-HP Hôpîtal Europeen Georges Pompidou

Paris, 75908, France

Location

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet,

Pierre-Bénite, 69495, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

Hôpital Robert Debré

Reims, 51092, France

Location

CHU Charles Nicolle

Rouen, ROUEN, France

Location

CHU Nord

Saint-Etienne, 42055, France

Location

Institut Cancérologie de l'Ouest - René Gauducheau

Saint-Herblain, 44805, France

Location

CHRU Hautepierre

Strasbourg, 67098, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Hôpital Purpan

Toulouse, 31059, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Pseudomyxoma PeritoneiDesmoplastic Small Round Cell TumorCystadenocarcinoma, Serous

Condition Hierarchy (Ancestors)

Adenocarcinoma, MucinousAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Cystic, Mucinous, and SerousSarcomaNeoplasms, Connective and Soft TissueCystadenocarcinoma

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
8 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 15, 2016

Study Start

October 1, 2010

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations