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Study of the Impact of VEGF Polymorphism on the Development of Renal Carcinoma in Renal Transplant Patients (VE-CART)

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ClinicalTrials.gov Identifier: NCT03114826
Recruitment Status : Unknown
Verified April 2017 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was:  Recruiting
First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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Brief Summary:

Renal transplant patients have on average 3-5 times more risk of developing cancer than the general population. This rate can be increased up to 10 to 15 times in some type of cancer like kidney cancer. Among the identified risk factors, immunosuppressants and, in particular, calcineurin inhibitors (ciclosporin and tacrolimus) play a major role in increasing cancers apart from their depressant effects on the immune system.

Calcineurin inhibitors (CCN) are the basis of immunosuppressive therapy in renal transplantation. Several mechanisms have been implicated to explain their pro-oncogenic properties. One related to an increase in VEGF expression seems particularly interesting in the study of renal cell carcinoma in the transplanted patient. Indeed, the physiopathology of kidney cancer has clearly been associated with an increase in the production of VEGF. Furthermore, some polymorphisms of the gene encoding VEGF have already been associated with the survival of patients with renal carcinoma and the circulating level of VEGF in the general population. The search for an association between the polymorphisms of the VEGF gene and renal carcinoma in renal transplant patients could thus identify patients whose risk of renal cell carcinoma (cRCC) post-transplantation is increased. If the involvement of certain polymorphisms in the development of cRCC was confirmed in this population, their research before the introduction of the immunosuppressive treatment would make it possible to direct the choice of treatment towards molecules without pro-oncogenic property in the Patients such as mTOR protein inhibitors (sirolimus, everolimus). This research project is therefore in line with the desire to move towards a more "personalized" medicine that could be beneficial for the patient.


Condition or disease Intervention/treatment
Polymorphism VEGF Renal Carcinoma Renal Transplantation Genetic: To study the polymorphism of the gene encoding VEGF (rs699947) as a predictive marker

Study Design
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Study Type : Observational
Estimated Enrollment : 272 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study of the Impact of VEGF Polymorphism on the Development of Renal Carcinoma in Renal Transplant Patients
Actual Study Start Date : October 6, 2016
Estimated Primary Completion Date : October 5, 2019
Estimated Study Completion Date : October 5, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Renal cell carcinoma in renal transplant patients Genetic: To study the polymorphism of the gene encoding VEGF (rs699947) as a predictive marker
Study the polymorphism of the gene encoding VEGF (rs699947) as a predictive marker of the occurrence of renal cell carcinoma in renal transplant patients.


Outcome Measures
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Primary Outcome Measures :
  1. Taqman allelic discrimination analysis allows to define, for each polymorphism studied, three genotypes: wild homozygote (WT / WT), heterozygote (WT / M), mutated homozygote (M / M). The presence of renal carcinoma was previously confirmed on biopsy. [ Time Frame: 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Renal transplant patients for the period 1 January 2002 to 31 December 2011
Criteria

Inclusion Criteria:

  • Patients receiving a first, second or third kidney transplant;
  • Patients receiving a transplant from a living or deceased donor, irrespective of the immunological risk;
  • Patients with health insurance coverage;
  • Live or deceased patients for which genomic DNA is available.
  • in cases : first diagnosis of native kidney cancer (histological type: papillary or clear cell)

Exclusion Criteria:

  • Minor transplant patients;
  • Patients transplanted before 1 January 2002;
  • Patients monitored in the interregion, but transplanted to another center;
  • Patients receiving a double graft (kidney plus other organ) or a bi-graft;
  • Patients not accepting that their medical data be included in the register;
  • Patients not accepting that their specimen be used for scientific research purposes.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114826


Contacts
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Contact: Sandra BODEAU, Dr +33322087034 bodeau.sandra@chu-amiens.fr

Locations
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France
CHU Amiens Picardie Recruiting
Amiens, Picardie, France, 80054
Contact: Sandra BODEAU, Dr    +33322087029    bodeau.sandra@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
More Information
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03114826    
Other Study ID Numbers: PI2015_843_0015
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases