Completed

NCT Number: NCT05198427

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.

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Key information

Conditions

Transplantation Organ

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Edouard Herriot

Lyon, Auvergne-Rhône-Alpes, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: MOTIF

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jan 20, 2022
Registry last updated: Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.