mTOR Inhibitors: the Lesions Induced by Papillomavirus for Transplant Patients.

Completed

• Conditions: Transplantation Organ

• Registration Number: NCT05198427
• Lead Sponsor: Hospices Civils de Lyon

Brief 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. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-01-20
• Study Start: 2022-02-14
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 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

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Exclusion Criteria

• Transplanted patient without HPV-induced lesions

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evolution of HPV related lesions in patient without switch	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.
Evolution of HPV related lesions in patient with switch	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.

Trial Locations

Locations (1)

Hôpital Edouard Herriot; 🇫🇷 Lyon, Rhône-Alpes, France