Perivascular Epithelioid Cell Tumor, MalignantPEComesCellsNCT05617105
Molecular Characterization of Perivascular Epithelioid Cell Tumors
An observational study of Perivascular Epithelioid Cell Tumor, Malignant, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Perivascular Epithelioid Cell Tumor, Malignant
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2019to 31 Dec 2022
- 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
- Child, Adult, Older adult
Study population: patients having PEComas diagnosed in France between 01/01/1990 and 15/09/2019 and reviewed by a sarcoma referral pathologist
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Oncologie - CHU de Strasbourg - France
Strasbourg, 67091
Gabriel MALOUF, MD, PhD, 33 3 88 11 51 41, malouf.gabriel@chru-strasbourg.fr
Gabriel MALOUF, MD, PhD
About this study
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.
- Keywords
- Perivascular epithelioid cell tumors, PEComas, Myomelanocytic markers, Angiomyolipomas, Lymphangioleiomyomatoses, Visceral tumors, Fluorescence In Situ Hybridization
- Medical subject headings
- Perivascular Epithelioid Cell Neoplasms, Angiomyolipoma, Lymphangioleiomyomatosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Files analysed retrospectively from January 01, 1990 to September 15, 2019 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 posted15 Nov 2022
- Study start1 Dec 2019
- Primary completionDec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perivascular Epithelioid Cell Tumor, MalignantStudies 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
- 100 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
- NCT05617105
- Sponsor's protocol ID
- 7550
- Acronym
- PEComesCells
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2022
- Last updated
- 15 Nov 2022
- 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 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characterization of Perivascular Epithelioid Cell Tumors
- ClinicalTrials.gov ID
- NCT05617105
- Acronym / sponsor ID
- PEComesCells / 7550
- Keywords
- Perivascular epithelioid cell tumors, PEComas, Myomelanocytic markers, Angiomyolipomas, Lymphangioleiomyomatoses, Visceral tumors, Fluorescence In Situ Hybridization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 15 Nov 2022 (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 (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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients having PEComas diagnosed in France between 01/01/1990 and 15/09/2019 and reviewed by a sarcoma referral pathologist
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
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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 Perivascular Epithelioid Cell Tumor, Malignant, 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 3 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 15 Nov 2022. 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 (33 3 88 11 51 41, malouf.gabriel@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 15 Nov 2022.