PEComasPEComasNCT03916575
PEComas: Natural History and Prognostic Factors
An observational study of PEComas, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- PEComas
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2019to Apr 2020
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient having PEComas diagnosed in France between 1990 and 2018
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service D'Hematologie Et D'Oncologie
Strasbourg, 67091
Gabriel MALOUF, MD, PhD, 33 3 88 11 62 22, gabriel.malouf@chru-strasbourg.fr
Agathe BOURGMAYER, MD
About this study
Official title: 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
- Conditions
- PEComas
- Medical subject headings
- Perivascular Epithelioid Cell Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the prognostic factors associated with the risk of relapse
Measured: The period from January 1st, 1990 to December 31, 2018 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start9 Apr 2019
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PEComasStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916575
- Sponsor's protocol ID
- 7337
- Acronym
- PEComas
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Multicenter Retrospective Study: PEComas: Natural History and Prognostic
- ClinicalTrials.gov ID
- NCT03916575
- Acronym / sponsor ID
- PEComas / 7337
- Conditions
- PEComas
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 16 Apr 2019 (actual)
- 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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient having PEComas diagnosed in France between 1990 and 2018
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PEComas, run by University Hospital, Strasbourg, France at 1 site 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 5 inclusion and 6 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 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Gabriel MALOUF, MD, PhD (03 88 11 62 22, gabriel.malouf@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2019.