Molecular Characterization of Perivascular Epithelioid Cell Tumors (PEComesCells)

November 7, 2022 updated by: University Hospital, Strasbourg, France
Perivascular epithelioid cell tumors (PEComas) are rare and are characterized by the expression of myomelanocytic markers. They are a complex family that includes angiomyolipomas, lymphangioleiomyomatoses and other soft tissue and visceral tumors. Due to the low prevalence of these tumors, the natural history is unclear; furthermore, a molecular classification integrating clinical, pathological and molecular parameters has not been described to date.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service d'Oncologie - CHU de Strasbourg - France
        • Principal Investigator:
          • Gabriel MALOUF, MD, PhD
        • Sub-Investigator:
          • Loïc CHAIGNEAU, MD
        • Contact:
        • Sub-Investigator:
          • Céline Charon-Barra, MD
        • Sub-Investigator:
          • Christine CHEVREAU, MD
        • Sub-Investigator:
          • François Bertucci, MD
        • Sub-Investigator:
          • Youenn DAVIDSON, Statistician

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients having PEComas diagnosed in France between 01/01/1990 and 15/09/2019 and reviewed by a sarcoma referral pathologist

Description

Inclusion criteria:

  • Major patient (≥18 years)
  • Minor patient (1 to 17 years old)
  • PEComas diagnosed in France between 01/01/1990 and 15/09/2019 and reviewed by a sarcoma referral pathologist

Exclusion criteria :

  • Opposition of the patient (or the holders of parental authority) to participate in the study
  • Biological tissue from a patient who does not meet all the inclusion criteria
  • Classic triphasic angiomyolipoma or lymphangioleiomyomatosis
  • Inability to provide informed information to the subject
  • Patient under court protection
  • Patient under guardianship or curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To retrospectively describe the percentage of tumors with FISH (Fluorescence In Situ Hybridization) identification of the TFE3 rearrangement out of 100 cases of PEComas diagnosed in France between 01 January 1990 and 15 September 2019
Time Frame: Files analysed retrospectively from January 01, 1990 to September 15, 2019 will be examined
Files analysed retrospectively from January 01, 1990 to September 15, 2019 will be examined

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7550

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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