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Trial record 44 of 303 for:    Recruiting, Not yet recruiting, Available Studies | Pediatrics

Review of the Paediatric Pleuropulmonary Blastoma French Series (PPB)

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ClinicalTrials.gov Identifier: NCT03044834
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:

Pleuropulmonary blastoma is a rare embryonic malignant tumour that remains the most frequent malignant tumour of the lung in childhood. The International Pleuro pulmonary Blastoma Registry (IPPB) found only 220 cases in 2009 and 350 in 2015. In France, 20 cases were identified in 2009.

Three histologies are described: type 1 purely cystic, type 2 combined and type 3 solid. Median age at diagnostic is 12 months, 35 months and 41 months respectively. Evolution is possible from type 1 to type 2 or 3 in 10% of the cases.

Since 2009, DICER 1 mutations research is proposed systematically to all families.

PPB symptoms are usually non-specific. Diagnostic is evoked when imaging work up shows bubbles or solid lesions, and confirmed by pathological analysis. However the diagnosis can be difficult because of the proximity with congenital cystic adenomatoid malformation.

The French society of paediatric oncology recommends surgery at first instance. PPB type 1 remains a problem because some are still misdiagnosed as CCAM, a benign lesion. Chemotherapy depends on the PPB type and the quality of the resection. There is a real interest to analyse the French series.

The prognosis of type 2 and 3 is low with a 5 years survival rate of 45-60%, whereas type 1 survival rate is 91%. The French experience reports a 100% survival rate in type 1 and 48% in type 2 and 3. Other prognostic factors are initial size of the tumour, extra pulmonary invasion and quality of surgery.

Early local relapses are possible and late ones concern more often type 2 and 3 with more cerebral metastasis.

In 2009, the french cases were collected, but no update has been performed since. The aim of this retrospective review of the cases since 2000, is to audit the care of PPB patients in France and update the French rare tumour database.

Evoking PPB diagnosis is difficult when imaging shows a neonatal cystic lesion. There are no radiologic criteria in the literature that differentiate congenital pulmonary cystic lesion and PPB type 1. Radiological presentation is however overlapping. Another aim of this study will be to look for a predictive sign of type 1 PPB.


Condition or disease Intervention/treatment
Pleuropulmonary Blastoma Other: PPB

Detailed Description:
Multicentre retrospective study

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Review of the Paediatric Pleuropulmonary Blastoma French Series
Actual Study Start Date : January 9, 2017
Estimated Primary Completion Date : July 9, 2018
Estimated Study Completion Date : July 9, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pleuropulmonary Blastoma
  • Patients born between 01/01/2000 and 01/01/2016 ;
  • Followed up for PPB
  • Treated in a French department of paediatric oncology or paediatric surgery
  • Study agreement
Other: PPB
Global current care




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Within 5 years from the diagnosis ]
  2. Progression free survival [ Time Frame: Within 5 years from the diagnosis ]
    Characterize the evolution and the global care of PPB in the French series


Secondary Outcome Measures :
  1. State of PPB surgical care [ Time Frame: Within 5 years from the diagnosis ]
  2. Radiology sign [ Time Frame: Within 5 years from the diagnosis ]
    Identification of a type 1 PPB predictive radiological sign



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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients born between 01/01/2000 and 01/01/2016, followed up for PPB, treated in a French department of paediatric oncology or paediatric surgery.
Criteria

Inclusion Criteria:

  • Patients born between 01/01/2000 and 01/01/2016 ;
  • Followed up for PPB
  • Treated in a French department of paediatric oncology or paediatric surgery
  • Study agreement

Exclusion Criteria:

  • Part of the care out of France
  • Study disagreement

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): NCT03044834


Contacts
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Contact: Alexis ARNAUD, MD alexis.arnaud@chu-rennes.fr

Locations
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France
Angers University Hospital Recruiting
Angers, France, 49000
Contact: Guillaume PODEVIN, MD         
Principal Investigator: Guillaume PODEVIN, MD         
Bordeaux University Hospital Recruiting
Bordeaux, France, 33000
Contact: Cécile VERITE-GOULARD, MD         
Principal Investigator: Cécile VERITE-GOULARD, MD         
Caen University Hospital Recruiting
Caen, France, 14000
Contact: Odile MINCKES, MD         
Principal Investigator: Odile MINCKES, MD         
Grenoble University Hospital Recruiting
Grenoble, France, 38000
Contact: Dominique PLANTAZ, MD         
Principal Investigator: Dominique PLANTAZ, MD         
Kremlin-Bicêtre Hospital Recruiting
Le Kremlin-Bicêtre, France, 94000
Contact: Florent GUERIN, MD         
Principal Investigator: Florent GUERIN, MD         
Lille University Hospital Not yet recruiting
Lille, France, 59000
Contact: Hélène SUDOUR-BONNANGE, MD         
Principal Investigator: Hélène SUDOUR-BONNANGE, MD         
Lyon Universty Hospital Recruiting
Lyon, France, 69000
Contact: Frédéric HAMEURY, MD         
Principal Investigator: Frédéric HAMEURY, MD         
Marseille University Hospital Not yet recruiting
Marseille, France, 13000
Contact: Nicolas ANDRE, MD         
Principal Investigator: Nicolas ANDRE, MD         
Montpellier University Hospital Recruiting
Montpellier, France, 34000
Contact: Nicolas KALFA, MD         
Principal Investigator: Nicolas KALFA, MD         
Principal Investigator: Paula BORREGO, MD         
Nantes University Hospital Not yet recruiting
Nantes, France, 44000
Contact: Caroline THOMAS, MD         
Principal Investigator: Caroline THOMAS, MD         
Nice University Hospital Recruiting
Nice, France, 06000
Contact: Anne DEVILLE, MD         
Principal Investigator: Anne DEVILLE, MD         
Necher Hospital Recruiting
Paris, France, 75000
Contact: Naziha KHEN-DUNLOP, MD         
Principal Investigator: Naziha KHEN-DUNLOP, MD         
Poitiers University Hospital Not yet recruiting
Poitiers, France, 86000
Contact: Guillaume LEVARD, MD         
Principal Investigator: Guillaume LEVARD, MD         
Principal Investigator: Frédéric MILLOT, MD         
Curie Institute Not yet recruiting
Saint-Cloud, France, 92000
Contact: Daniel ORBACH, MD         
Principal Investigator: Daniel ORBACH, MD         
Réunion University Hospital Recruiting
Saint-Paul, France, 97000
Contact: Yves REGUERRE, MD         
Principal Investigator: Yves REGUERRE, MD         
Toulouse University Hospital Recruiting
Toulouse, France, 31000
Contact: Ollivier ABBO, MD         
Principal Investigator: Ollivier ABBO, MD         
Tours University Hospital Recruiting
Tours, France, 37000
Contact: Anne JOURDAIN, MD         
Principal Investigator: Anne JOURDAIN, MD         
Gustave Roussy Institute Not yet recruiting
Villejuif, France, 94000
Contact: Véronique MINARD, MD         
Principal Investigator: Véronique MINARD, MD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Alexis ARNAUD, MD Rennes University Hospital

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03044834     History of Changes
Other Study ID Numbers: 35RC15_3009_PPB
15.18 ( Other Identifier: Comité d'Ethique Régional de Rennes )
15.468 ( Other Identifier: CCTIRS )
915465 ( Other Identifier: CNIL )
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Pulmonary Blastoma
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site