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Trial record 9 of 9 for:
"Leiomyomatosis"
French National Registry of Rare Peritoneal Surface Malignancies (RENAPE)
This study is ongoing, but not recruiting participants.
Sponsor:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT02834169
First received: June 30, 2016
Last updated: July 12, 2016
Last verified: June 2016
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Purpose
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 | Intervention |
|---|---|
| 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 Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Cohort |
| Target Follow-Up Duration: | 8 Years |
| Official Title: | French National Registry of Rare Peritoneal Surface Malignancies (RENAPE Registry) |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Malignant Mesothelioma
Pseudomyxoma Peritonei
Gelatinous Ascites
Desmoplastic Small Round Cell Tumor
Intravenous Leiomyomatosis
Disseminated Peritoneal Leiomyomatosis
Adenocarcinoma of the Appendix
Soft Tissue Sarcoma
U.S. FDA Resources
Further study details as provided by Hospices Civils de Lyon:
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
| Enrollment: | 2171 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02834169
Please refer to this study by its ClinicalTrials.gov identifier: NCT02834169
Locations
| 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
| 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:
| Responsible Party: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT02834169 History of Changes |
| Other Study ID Numbers: |
69HCL16_0406 |
| Study First Received: | June 30, 2016 |
| Last Updated: | July 12, 2016 |
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:
|
Leiomyomatosis Neoplasms Mesothelioma Desmoplastic Small Round Cell Tumor Cystadenocarcinoma, Serous Pseudomyxoma Peritonei Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms, Mesothelial Sarcoma Neoplasms, Connective and Soft Tissue Cystadenocarcinoma Adenocarcinoma Carcinoma Neoplasms, Cystic, Mucinous, and Serous Leiomyoma Neoplasms, Muscle Tissue |
ClinicalTrials.gov processed this record on July 14, 2017