Study of Cancers After Solid Organs Transplants

Cancer Clinical Trial

— K-GREF  

Official title:

Epidemiological, Immunological, Pathological and Pharmacogenetic Study of Cancers Occuring After Solid Organs Transplants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948883
• Other study ID #: DRCD CANC 0701
• Status: Completed
• Phase: N/A
• First received: July 28, 2009
• Last updated: April 3, 2013
• Start date: October 2008
• Est. completion date: July 2011

Study information

• Verified date: April 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer
• Organ Transplantation

Locations

Country	Name	City	State
France	Hôpital Bicêtre - Assistance Publique-Hôpitaux de Paris	Le Kremlin Bicetre Cedex

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	CANCEROPOLE Ile-de-France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cancer among transplanted patients.		At the day of blood collection	Yes
Secondary	Characteristics of the tumors.		At the day of blood collection	No
Secondary	Risk factors of the tumors.		At the day of blood collection	No