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

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.

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 Overview

• Status: Completed
• Conditions: Transplantation Organ
• Intervention / Treatment: Other: review of medical patient file

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• France
  • Rhône-Alpes
    • Lyon, Rhône-Alpes, France, 69003
      • Hôpital Edouard Herriot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient transplanted with HPV-induced lesions from the DIVAT (Validated Transplantation Computerized Data) database for patients followed at the hospital Edouard Herriot

Description

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

Exclusion Criteria:

• Transplanted patient without HPV-induced lesions

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	at inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Fanny BURON, MD, Hôpital Rdouard Herriot

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 69HCL21_1395

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No