Study of Cancers After Solid Organs Transplants (K-GREF)
This study has been completed.
Sponsor:
Assistance Publique - Hôpitaux de Paris
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
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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 May 23, 2013