Clinical trial NCT00948883: Study of Cancers After Solid Organs Transplants
Official title: Epidemiological, Immunological, Pathological and Pharmacogenetic Study of Cancers Occuring After Solid Organs Transplants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Organ Transplantation
Keywords: organ transplant
cancer
biobank
immunosuppressive drugs
lymphoma
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: CANCEROPOLE Ile-de-France
First posted: 2009-07-29
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with solid organ transplant who have developed a cancer. Patients with solid organ transplant who have not developed a cancer.

Brief summary: About 1500 solid organs transplants are performed each year in the Paris agglomeration.

Cancer risk in the transplanted is about three times higher than in a population of the same age without any organ transplant. Thus cancer is an important problem for organ transplant.

These cancers can be related to many factors :

* Post-transplant cancers are due in part to the non specific immunosuppression, which leads to oncogenic viruses replication, and then produces virus inducted cancers (as lymphoma due to EBV virus).
* Post-transplant cancers can also be due to the carcinogenic factors of the immunosuppressive drugs (as cyclosporine or tacrolimus, which can cause the appearance of metastases). However, a new type of immunosuppressive drugs (mTOR inhibitors) appear to have anti-cancer properties.
* Post-transplant cancers which are not virus-inducted can be relied to genetic factors of the transplanted patient and/or the transplant donor.

There are 4 axes in this study :

* Axis 1 : Epidemiological, clinical and biological study of the incident cancers in transplanted patients.
* Axis 2 : Qualitative and quantitative immunological study of lymphocyte cells by the transplanted patient (determine their characteristics when a cancer appears).
* Axis 3 : Pathological and genetic study of the post-transplant cancer cells (see if the cancer is caused by the donor or the recipient). Creation of a biobank.
* Axis 4 : Pharmacogenetic study of the immunosuppressive drugs (determine the impact of patient genetic variability on tolerance and efficiency of the immunosuppressive drugs).

Detailed description: This is an observational and comparative study (2 control patients are recruited for each 1 case patient).

A case patient is a patient who has developed a cancer after his/her transplant.

A control patient is a patient who has not developed a cancer after his/her transplant.

These 2 groups will be matched according to specific inclusion criteria.

Eligibility criteria: Inclusion Criteria:

* Man or woman after 18 years old
* Transplanted with a solid organ (heart, kidney, lung,liver)
* Informed Consent Form signed
* For the patients-case: Patients who developed a post-transplant cancer
* For the patients-control: Patients who didn't develop a post-transplant cancer

Exclusion Criteria:

* Cancer as transplant indication ( except liver )
* HIV positive

Primary outcomes:
measure: Incidence of cancer among transplanted patients.
timeFrame: At the day of blood collection
Secondary outcomes:
measure: Characteristics of the tumors.
timeFrame: At the day of blood collection
measure: Risk factors of the tumors.
timeFrame: At the day of blood collection
Other outcomes:
Locations:
city: Le Kremlin Bicetre Cedex
country: France
facility: Hôpital Bicêtre - Assistance Publique-Hôpitaux de Paris
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Michel MARTY, MD
role: PRINCIPAL_INVESTIGATOR
References: