Study of Cancers After Solid Organs Transplants

NCT00948883 | Completed DMC

• 1 other identifier: DRCD CANC 0701
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cancer; Organ Transplantation

Keywords

organ transplant; cancer; biobank; immunosuppressive drugs; lymphoma

Outcome Measures

Primary Outcomes (1)

• Incidence of cancer among transplanted patients.

  At the day of blood collection

Secondary Outcomes (2)

• Characteristics of the tumors.

  At the day of blood collection

• Risk factors of the tumors.

  At the day of blood collection

Study Arms (2)

Patient-Case

Transplanted patient with cancer

Patient-Control

Transplanted patient without cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Cancer as transplant indication ( except liver )
• HIV positive

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• CANCEROPOLE Ile-de-France: collaborator

Study Sites (1)

Hôpital Bicêtre - Assistance Publique-Hôpitaux de Paris

Le Kremlin-Bicêtre, 94275, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, frozen tissue

MeSH Terms

Conditions

Neoplasms; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Michel MARTY, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: July 29, 2009
• Study Start: October 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

FR (1)