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In a population of kidney transplant recipients having developed a first squamous cell carcinoma, the aim of the study is to assess the incidence of subsequent skin cancers over 2 years in patients who are switched to rapamycin as compared to patients who are maintained under calcineurin inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | patients receiving Rapamycin |
|
| 2 | Active Comparator | patients receiving anticalcineurin treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rapamycin | Drug | 3 to 5 mg/day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the incidence of new squamous cell carcinoma in kidney transplant recipients | during 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the incidence of other non skin cancer in kidney transplant recipients | during 5 years | |
| To assess the graft survival | during 5 years | |
| To assess the tolerance of rapamycin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie EUVRARD, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Edouard Herriot - Service de Dermatologie | Lyon | 69003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30016177 | Result | Dantal J, Morelon E, Rostaing L, Goffin E, Brocard A, Tromme I, Broeders N, Del Marmol V, Chatelet V, Dompmartin A, Kessler M, Serra A, Hofbauer GFL, Kamar N, Pouteil-Noble C, Kanitakis J, Roux A, Decullier E, Euvrard S; TUMORAPA Study Group. Sirolimus for Secondary Prevention of Skin Cancer in Kidney Transplant Recipients: 5-Year Results. J Clin Oncol. 2018 Sep 1;36(25):2612-2620. doi: 10.1200/JCO.2017.76.6691. Epub 2018 Jul 17. | |
| 22830463 |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D003524 | Cyclosporins |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D010456 | Peptides, Cyclic |
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| ciclosporine |
| Drug |
Blood residual level < or = to 125 ng/ml |
|
| tacrolimus | Drug | Blood residual level < or = to 8 ng/ml |
|
| during 5 years |
| Result |
| Euvrard S, Morelon E, Rostaing L, Goffin E, Brocard A, Tromme I, Broeders N, del Marmol V, Chatelet V, Dompmartin A, Kessler M, Serra AL, Hofbauer GF, Pouteil-Noble C, Campistol JM, Kanitakis J, Roux AS, Decullier E, Dantal J; TUMORAPA Study Group. Sirolimus and secondary skin-cancer prevention in kidney transplantation. N Engl J Med. 2012 Jul 26;367(4):329-39. doi: 10.1056/NEJMoa1204166. |
| 15753371 | Result | Aractingi S, Kanitakis J, Euvrard S, Le Danff C, Peguillet I, Khosrotehrani K, Lantz O, Carosella ED. Skin carcinoma arising from donor cells in a kidney transplant recipient. Cancer Res. 2005 Mar 1;65(5):1755-60. doi: 10.1158/0008-5472.CAN-04-2783. |
| 15061852 | Result | Martinez JC, Otley CC, Euvrard S, Arpey CJ, Stasko T; International Transplant-Skin Cancer Collaborative. Complications of systemic retinoid therapy in organ transplant recipients with squamous cell carcinoma. Dermatol Surg. 2004 Apr;30(4 Pt 2):662-6. doi: 10.1111/j.1524-4725.2004.30153.x. |
| D002277 |
| Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D047028 |
| Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |