Study of Cancers After Solid Organs Transplants (K-GREF)

This study has been completed.
Sponsor:
Collaborator:
CANCEROPOLE Ile-de-France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00948883
First received: July 28, 2009
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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).

Condition
Cancer
Organ Transplantation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Epidemiological, Immunological, Pathological and Pharmacogenetic Study of Cancers Occuring After Solid Organs Transplants

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Incidence of cancer among transplanted patients. [ Time Frame: At the day of blood collection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characteristics of the tumors. [ Time Frame: At the day of blood collection ] [ Designated as safety issue: No ]
  • Risk factors of the tumors. [ Time Frame: At the day of blood collection ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, frozen tissue


Enrollment: 330
Study Start Date: October 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patient-Case
Transplanted patient with cancer
Patient-Control
Transplanted patient without cancer

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948883

Locations
France
Hôpital Bicêtre - Assistance Publique-Hôpitaux de Paris
Le Kremlin Bicetre Cedex, France, 94275
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
CANCEROPOLE Ile-de-France
Investigators
Principal Investigator: Michel MARTY, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00948883     History of Changes
Other Study ID Numbers: DRCD CANC 0701
Study First Received: July 28, 2009
Last Updated: April 3, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
organ transplant
cancer
biobank
immunosuppressive drugs
lymphoma

ClinicalTrials.gov processed this record on April 17, 2014