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

NCT05198427 | Completed

• 1 other identifier: 69HCL21_1395
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Transplantation Organ

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

review of medical patient file OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Transplanted patient without HPV-induced lesions

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Edouard Herriot

Lyon, Auvergne-Rhône-Alpes, 69003, France

Location

Study Officials

• Fanny BURON, MD

  Hôpital Rdouard Herriot

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 20, 2022
• Study Start: February 14, 2022
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

FR (1)