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Clinical Trials/NCT03114826
NCT03114826CompletedNot Applicable

Study of the Impact of VEGF Polymorphism on the Development of Renal Carcinoma in Renal Transplant Patients

Centre Hospitalier Universitaire, Amiens1 site in 1 country272 target enrollmentStarted: October 6, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
272
Locations
1
Primary Endpoint
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.

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Renal cell carcinoma in renal transplant patients

Intervention: To study the polymorphism of the gene encoding VEGF (rs699947) as a predictive marker (Genetic)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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