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

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT05198427
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Actual Duration (Months): 1.5
• Patients Per Site Per Month: 30.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transplantation Organ	Other: review of medical patient file

Study Design

• Study Type: Observational
• Actual Enrollment: 45 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Study MOTIF : mTOR Inhibitors: the Lesions Induced by Papillomavirus for Transplant Patients
• Actual Study Start Date: Feb 14, 2022
• Actual Primary Completion Date: Mar 31, 2022
• Actual Study Completion Date: Mar 31, 2022

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Edouard Herriot	Lyon	Rhône-Alpes	France	69003

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

• Principal Investigator: Fanny BURON, MD, Hôpital Rdouard Herriot

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT05198427
• Other Study ID Numbers: 69HCL21_1395
• First Posted: Jan 20, 2022
• Last Update Posted: Apr 14, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 14, 2022