NCT00948883

Completed

Study of Cancers After Solid Organs Transplants

Assistance Publique - Hôpitaux de Paris Source

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Other study identifiers

Sponsor study identifier

DRCD CANC 0701

Study Type

observational

Actual enrollment (reported)

330

Locations

1 country

Sites

1

Timeline

Study Start

October 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2011

Actual (reported)

Study Completion

July 2011

Actual (reported)

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).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 330 participants
Study completion date: July 2011
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2008
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
July 28, 2009
Actual (reported)
First Posted
July 29, 2009
Actual (reported)
Primary Completion
July 2011
Actual (reported)
Study Completion
July 2011
Actual (reported)

Last Updated: April 4, 2013
Status Verified: April 2013
Last Update Submitted: April 3, 2013

Conditions

Cancer Organ Transplantation

Keywords

organ transplantcancerbiobankimmunosuppressive drugslymphoma

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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

Sponsors & Collaborators

Cancéropôle Ile De France
Othercollaborator
Assistance Publique - Hôpitaux de Paris
Otherlead

Study Sites (1)

Hôpital Bicêtre - Assistance Publique-Hôpitaux de Paris

Le Kremlin-Bicêtre, 94275, France

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, frozen tissue

MeSH Terms

Conditions

NeoplasmsLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

Michel MARTY, MD
Assistance Publique - Hôpitaux de Paris
PRINCIPAL INVESTIGATOR

Enrollment

330 participants (actual enrollment reported by the registry).

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 2008

Date type not reported

This date has not been verified as actual or estimated.

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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

Contact the study team to confirm eligibility.

Primary Completion

July 2011

Actual (reported)

Study Completion

July 2011

Actual (reported)

Last Updated

April 4, 2013

Record last verified: 2013-04

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00948883
Data provider: ClinicalTrials.gov
Source updated: 2013-04-04
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:02 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Patient-Case

Patient-Control

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations