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NCT Number: NCT00948883

Study of Cancers After Solid Organs Transplants

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Bicêtre - Assistance Publique-Hôpitaux de Paris

Le Kremlin-Bicêtre, 94275, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of cancer among transplanted patients.

    Time frame: At the day of blood collection

Secondary outcomes

  1. Characteristics of the tumors.

    Time frame: At the day of blood collection

  2. Risk factors of the tumors.

    Time frame: At the day of blood collection

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Cancéropôle Ile De France

Registry information

Official study title

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

Acronym: K-GREF

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 29, 2009
Registry last updated
Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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