NCT03114826

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2019

Completed
Last Updated

April 14, 2017

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

April 4, 2017

Last Update Submit

April 10, 2017

Conditions

Outcome Measures

Primary Outcomes (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.

    1 day

Study Arms (1)

Renal cell carcinoma in renal transplant patients

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

Interventions

Study the polymorphism of the gene encoding VEGF (rs699947) as a predictive marker of the occurrence of renal cell carcinoma in renal transplant patients.

Renal cell carcinoma in renal transplant patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Renal transplant patients for the period 1 January 2002 to 31 December 2011

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 14, 2017

Study Start

October 6, 2016

Primary Completion

October 5, 2019

Study Completion

October 5, 2019

Last Updated

April 14, 2017

Record last verified: 2017-04

Locations