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PEComas: Natural History and Prognostic Factors (PEComas)

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ClinicalTrials.gov Identifier: NCT03916575
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:

Perivascular epithelioid cell tumors are rare and characterized by the expression of myomelanocytic markers. They belong to a complex tumor family that includes angiomyolipomas, lymphangioleiomyomatosis and other soft-tissue tumors. Given their rarity, the natural history of pecomas is not yet understood, and a comprehensive classification that integrates clinical, pathological and molecular features has not been achieved as of today.

This study is a national multicenter retrospective study to better understand the natural history of PEComas, excluding lymphangioleiomyomatosis and classic triphasic angiomyolipomas.

The primary purpose is the identification of prognostic markers impacting the relapse. Secondaries purposes are to identify prognostic markers impacting the overall survival and to have a better understanding of natural history


Condition or disease
PEComas

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: National Multicenter Retrospective Study: PEComas: Natural History and Prognostic
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020



Primary Outcome Measures :
  1. Study of the prognostic factors associated with the risk of relapse [ Time Frame: The period from January 1st, 1990 to December 31, 2018 will be examined ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient having PEComas diagnosed in France between 1990 and 2018
Criteria

Inclusion Criteria:

  • Major patient (≥18 years old)
  • Minor patient (1 to 17 years old)
  • PEComas diagnosed in France between 1990 and 2018 and read back by a pathologist referent of sarcomas
  • Patient having agreed to the use of his medical data for the purpose of this research.
  • Parental authorities having given their agreement for the reuse of their child's medical data for the purpose of this research.

Exclusion Criteria:

  • Opposition of the patient (or his legal representative) to the reuse of his data for the purposes of this research
  • Impossibility of giving the subject clear information
  • Patient under safeguard of justice
  • Patient under guardianship
  • Lymphangioleiomyomatosis
  • Classic triphasic angiomyolipoma

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): NCT03916575


Contacts
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Contact: Gabriel MALOUF, MD, PhD 03 88 11 62 22 gabriel.malouf@chru-strasbourg.fr

Locations
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France
Service D'Hematologie Et D'Oncologie Recruiting
Strasbourg, France, 67091
Contact: Gabriel MALOUF, MD, PhD    33 3 88 11 62 22    gabriel.malouf@chru-strasbourg.fr   
Sub-Investigator: Agathe BOURGMAYER, MD         
Sub-Investigator: Thomas RYCKEWAERT, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03916575     History of Changes
Other Study ID Numbers: 7337
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Perivascular Epithelioid Cell Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms