Transplantation OrganMOTIFNCT05198427
mTOR Inhibitors: the Lesions Induced by Papillomavirus for Transplant Patients.
An observational study of Transplantation Organ, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The injuries induced by Human Papillomavirus (HPV) (anogenital condyloma mainly) are more frequent among transplanted patients due to their immunosuppression. These injuries are benign but they have a negative impact on the patients' quality of life. The initial treatment is topical and then surgical. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplantation Organ
- What is being tested?
- review of medical patient file
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2022to 31 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient transplanted with HPV-induced lesions from the DIVAT (Validated Transplantation Computerized Data) database for patients followed at the hospital Edouard Herriot
Who may be able to join
- Adult patient (Age ≥ 18 years)
- Transplanted patient (any organ), having developed HPV-induced lesions after transplantation
- Patient followed or having been followed at Edouard Herriot Hospital (HEH)
- Patient having been informed and not having objected to participating in the study
Who cannot join
- Transplanted patient without HPV-induced lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study MOTIF : mTOR Inhibitors: the Lesions Induced by Papillomavirus for Transplant Patients
The injuries induced by Human Papillomavirus (HPV) (anogenital condyloma mainly) are more frequent among transplanted patients due to their immunosuppression. These injuries are benign but they have a negative impact on the patients' quality of life. The initial treatment is topical and then surgical. The injuries can relapse, especially among transplanted patients.
The modification of the immunosuppressant treatment with a switch to mTOR inhibitors (mammalian Target Of Rapamycin) has shown its efficacy in preventing the recurrence of squamous cell carcinomas or treating Kaposi's disease.
Read more
By analogy, this therapeutic strategy can be sometimes put forward to transplanted patients with HPV-induced injuries.
The principal objective of this study is to describe the evolution of HPV-induced lesions in solid organ transplant patients.
- Conditions
- Transplantation Organ
- Being tested
- review of medical patient file
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
review of medical patient fileOther
The outcome measure is the evolution of HPV related lesions between :
- favourable evolution including partial or total regression
- unfavourable evolution including non-evolution or aggravation or recurrence.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of HPV related lesions in patient with switch
At one year of the switch by an inhibitor of mTOR then remotely of the switch (by tacking the last medical encounter) for the patients concerned by the switch.
Measured: at inclusion
Evolution of HPV related lesions in patient without switch
At one year of the first HPV related lesions care then remotely (by tacking the last medical encounter) for the patients without the switch.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start14 Feb 2022
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation OrganStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanny BURON, MD, Principal investigator, Hôpital Rdouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198427
- Sponsor's protocol ID
- 69HCL21_1395
- Acronym
- MOTIF
- Status last verified
- Apr 2022
- First submitted
- 12 Jan 2022
- Last updated
- 14 Apr 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 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study MOTIF : mTOR Inhibitors: the Lesions Induced by Papillomavirus for Transplant Patients
- ClinicalTrials.gov ID
- NCT05198427
- Acronym / sponsor ID
- MOTIF / 69HCL21_1395
- Conditions
- Transplantation Organ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 20 Jan 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.
The injuries induced by Human Papillomavirus (HPV) (anogenital condyloma mainly) are more frequent among transplanted patients due to their immunosuppression. These injuries are benign but they have a negative impact on the patients' quality of life. The initial treatment is topical and then surgical. The injuries can relapse, especially among transplanted patients.
The modification of the immunosuppressant treatment with a switch to mTOR inhibitors (mammalian Target Of Rapamycin) has shown its efficacy in preventing the recurrence of squamous cell carcinomas or treating Kaposi's disease.
By analogy, this therapeutic strategy can be sometimes put forward to transplanted patients with HPV-induced injuries.
The principal objective of this study is to describe the evolution of HPV-induced lesions in solid organ transplant patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient transplanted with HPV-induced lesions from the DIVAT (Validated Transplantation Computerized Data) database for patients followed at the hospital Edouard Herriot
Key inclusion criteria (4 listed)
- Adult patient (Age ≥ 18 years)
- Transplanted patient (any organ), having developed HPV-induced lesions after transplantation
- Patient followed or having been followed at Edouard Herriot Hospital (HEH)
- Patient having been informed and not having objected to participating in the study
Key exclusion criteria (1 listed)
- Transplanted patient without HPV-induced lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| review of medical patient fileThe outcome measure is the evolution of HPV related lesions between : * favourable evolution including partial or total regression * unfavourable evolution including non-evolution or aggravation or recurrence. | Other | – |
Primary outcome
Evolution of HPV related lesions in patient with switch
Time frame: at inclusion
At one year of the switch by an inhibitor of mTOR then remotely of the switch (by tacking the last medical encounter) for the patients concerned by the switch.
Evolution of HPV related lesions in patient without switch
Time frame: at inclusion
At one year of the first HPV related lesions care then remotely (by tacking the last medical encounter) for the patients without the switch.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 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.
Fanny BURON, MD principal investigator
Hôpital Rdouard Herriot
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 Transplantation Organ, run by Hospices Civils de Lyon 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 14 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of HPV related lesions in patient with switch (time frame: at inclusion). The study lists 2 primary outcomes in all. 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 14 Apr 2022.