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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014