PEComas: Natural History and Prognostic Factors (PEComas)

April 29, 2019 updated by: University Hospital, Strasbourg, France

National Multicenter Retrospective Study: PEComas: Natural History and Prognostic

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

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

Study Locations

      • Strasbourg, France, 67091
        • Recruiting
        • Service d'Hématologie et d'Oncologie

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 (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient having PEComas diagnosed in France between 1990 and 2018

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
The period from January 1st, 1990 to December 31, 2018 will be examined

Collaborators and Investigators

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

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)

April 9, 2019

Primary Completion (ANTICIPATED)

April 1, 2020

Study Completion (ANTICIPATED)

April 1, 2020

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 15, 2019

First Posted (ACTUAL)

April 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

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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