Rare Peritoneal Surface MalignanciesRENAPENCT02834169
French National Registry of Rare Peritoneal Surface Malignancies
An observational study of Rare Peritoneal Surface Malignancies and Pseudomyxoma Peritonei, run by Hospices Civils de Lyon at 33 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rare Peritoneal Surface Malignancies, Pseudomyxoma Peritonei, Peritoneal Mesothelioma
- What is being tested?
- Non interventional
- How many people
- 2,171 participants
- Where
- 33 sitesFrance
- Study dates
- Oct 2010to Dec 2018
- How long will I take part?
- 8 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prospectively or retrospectively diagnosed patients with rare peritoneal surface malignancies.
Who may be able to join
- Patients are eligible if they have a histologically proven rare peritoneal surface malignancy.
Who cannot join
- Histological diagnostic of peritoneal surface malignancy not confirmed
- Expected clinical follow up data not available
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
France33 sites
Institut de Cancérologie de l'Ouest - Paul Papin
Angers, 49100
CHU Jean Minjoz
Besançon, 25030
Institut Bergonié
Bordeaux, 33076
Centre François Baclesse
Caen, 14076
CHU Estaing
Clermont-Ferrand, 63003
Centre Jean Perrin
Clermont-Ferrand, 63011
AP-HP Louis MOURIER
Colombes, 92700
CHU Bocage
Dijon, 21079
CHU A. Michallon
La Tronche, 38700
Centre Oscar Lambret
Lille, 59020
CHRU Claude Huriez
Lille, 59037
Centre Léon Bérard
Lyon, 69008
Institut Paoli Calmettes
Marseille, 13273
Hôpital La Timône
Marseille, 13385
Institut du Cancer Montpellier
Montpellier, 34298
CHU Nantes Hôtel-Dieu
Nantes, 44093
CHU L'Archet II
Nice, 06200
Institut Curie
Paris, 75005
AP-HP St Antoine
Paris, 75012
AP-HP La Pitié-Salpêtrière
Paris, 75013
AP-HP Lariboisière
Paris, 75475
AP-HP Hôpîtal Europeen Georges Pompidou
Paris, 75908
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet,
Pierre-Bénite, 69495
CHU Poitiers
Poitiers, 86021
Hôpital Robert Debré
Reims, 51092
CHU Charles Nicolle
Rouen, ROUEN
CHU Nord
Saint-Etienne, 42055
Institut Cancérologie de l'Ouest - René Gauducheau
Saint-Herblain, 44805
CHRU Hautepierre
Strasbourg, 67098
Institut Claudius Regaud
Toulouse, 31052
Hôpital Purpan
Toulouse, 31059
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: 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.
- Conditions
- Rare Peritoneal Surface Malignancies, Pseudomyxoma Peritonei, Peritoneal Mesothelioma, Desmoplastic Small Round Cell Tumor, Psammocarcinoma, Primary Peritoneal Serous Carcinoma
- Being tested
- Non interventional
- Keywords
- 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
- Medical subject headings
- Pseudomyxoma Peritonei, Desmoplastic Small Round Cell Tumor, Cystadenocarcinoma, Serous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventionalOther
Data collection
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: Other: Non interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of rare peritoneal surface malignancies
Collect detailed clinical and histological diagnosis for estimating annual incidence rate
Measured: year 5
Secondary outcomes (1)
Impact of specific treatment strategies
Collect detailed therapeutic strategies (surgical procedure, chemotherapy, etc.) on patients with rare peritoneal surface malignancies
Measured: year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startOct 2010
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rare Peritoneal Surface MalignanciesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,171 participants (actual)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François-Noël GILLY, Prof, Principal investigator, Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet, PIERRE-BENITE, FRANCE, 69495
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834169
- Sponsor's protocol ID
- 69HCL16_0406
- Acronym
- RENAPE
- Status last verified
- Aug 2017
- First submitted
- 30 Jun 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28212684
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French National Registry of Rare Peritoneal Surface Malignancies (RENAPE Registry)
- ClinicalTrials.gov ID
- NCT02834169
- Acronym / sponsor ID
- RENAPE / 69HCL16_0406
- Conditions
- Rare Peritoneal Surface Malignancies, Pseudomyxoma Peritonei, Peritoneal Mesothelioma, Desmoplastic Small Round Cell Tumor, Psammocarcinoma, Primary Peritoneal Serous Carcinoma
- Keywords
- Rare peritoneal surface malignancies, pseudomyxoma peritonei, peritoneal mesothelioma, desmoplastic small round cell tumor, psammocarcinoma, primary peritoneal serous carcinoma, diffuse peritoneal leiomyomatosis, appendiceal mucinous neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,171 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 8 Years
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| pseudomyxoma peritonei | – | Other: Non interventionalData 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). |
| peritoneal mesothelioma | – | Other: Non interventionalData 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). |
| desmoplastic small round cell tumor | – | Other: Non interventionalData 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). |
| psammocarcinoma | – | Other: Non interventionalData 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). |
| primary peritoneal serous carcinoma | – | Other: Non interventionalData 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). |
| diffuse peritoneal leiomyomatosis | – | Other: Non interventionalData 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). |
| appendiceal mucinous neoplasms | – | Other: Non interventionalData 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prospectively or retrospectively diagnosed patients with rare peritoneal surface malignancies.
Key inclusion criteria (1 listed)
- Patients are eligible if they have a histologically proven rare peritoneal surface malignancy.
Key exclusion criteria (2 listed)
- Histological diagnostic of peritoneal surface malignancy not confirmed
- Expected clinical follow up data not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventionalData collection | Other | appendiceal mucinous neoplasms, desmoplastic small round cell tumor, diffuse peritoneal leiomyomatosis, peritoneal mesothelioma, primary peritoneal serous carcinoma, psammocarcinoma, pseudomyxoma peritonei |
Primary outcome
Incidence of rare peritoneal surface malignancies
Time frame: year 5
Collect detailed clinical and histological diagnosis for estimating annual incidence rate
1 secondary outcome
Impact of specific treatment strategies
Time frame: year 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Derived from this study: PubMed 28212684Villeneuve 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 InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Rare Peritoneal Surface Malignancies
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The Appendix Cancer PMP Research Foundation Natural History Study/Patient Registry
Appendix Cancer, Pseudomyxoma Peritonei
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François-Noël GILLY, Prof principal investigator
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet, PIERRE-BENITE, FRANCE, 69495
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rare Peritoneal Surface Malignancies and Pseudomyxoma Peritonei, run by Hospices Civils de Lyon at 33 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of rare peritoneal surface malignancies (time frame: year 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02834169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.