Cancer of KidneyFRISCNCT02121730
Identification of Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais , Normandy and Picardy Regions
An observational study of Cancer of Kidney, run by Centre Hospitalier Universitaire, Amiens at 4 sites in France.
Trial summary
Kidney transplantation is now the treatment of choice for end-stage renal disease (ESRD). Between 2800 and 3000 kidney transplants are performed each year in France and more than 33 000 patients are living with a functioning graft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Kidney
- How many people
- 2,500 participants
- Where
- 4 sitesFrance
- Study dates
- 17 Nov 2014to 15 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had undergone renal transplantation for 10 years in the French interregion Northwest (Normandy, Picardy and Nord-Pas de Calais).
Who may be able to join
- All adult renal transplant patients in the 4 centers of interregion North - West
- Patients transplanted during the period from 1 January 2002 and 31 December 2011
- Patients recipients of first, second or third renal transplantation
- Patients transplant recipients from a living or deceased donor whatever the immunological risk
- Eligible patients will be included after being informed by their doctor and after accepting their data to be processed in the framework of this study
- Patient with a health insurance coverage
Who cannot join
- Patients transplanted as child
- Patients transplanted before 1 January 2002
- Patients followed in the interregion but transplanted in another center
- Patients recipients of a double transplant (two kidneys or kidney plus other organ)
- Patients that do not accept their medical data to be included in the database
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Amiens
Amiens, 80000
CHU CAEN
Caen, 14000
Chru Lille
Lille, 59000
Chu Rouen
Rouen, 76000
About this study
Official title: Identification of Key Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais, Normandy and Picardy Regions
Kidney transplantation is now the treatment of choice for end-stage renal disease (ESRD). Between 2800 and 3000 kidney transplants are performed each year in France and more than 33 000 patients are living with a functioning graft.
Preventing allograft rejection requires the use of immunosuppressive therapy, the intensity decreases as the distance from the day of transplantation. Unfortunately, treatment favors certain complications, including infectious and neoplastic. These represent a major cause of mortality in these patients. If the frequency of skin cancer is greatly increased in this population, that of solid tumors remains a concern. Approximately 20% of patients develop cancer after 10 years of graft , half non- skin cancers, the main risk factor is immunosuppressive therapy .
The aim of the study is to evaluate, in a large population of patients treated in 4 regions ( the Nord-Pas de Calais, the Upper and Lower Normandy and Picardy) risk factors (in particular the nature of the immunosuppressive treatment) of developing a neoplastic complication, skin cancers and solid tumors, after renal transplantation.
Read the detailed description
A retrospective analysis of the previous 10 years, from 2002 to 2011 will be conducted. This study will better understand the epidemiology of these complications but also allow to identify risk factors associated, including demographic, environmental and related to immunosuppressive therapy.
Thereafter, we hope to implement preventive measures or prospective studies, allowing us to reduce the prevalence of this complication.
- Conditions
- Cancer of Kidney
- Keywords
- grafting kidney, Cancer
- Medical subject headings
- Kidney Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Kidney Transplantation | Patients who had undergone renal transplantation for 10 years in the interregion Northwest (Normandy, Picardy and Nord-Pas de Calais). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between neoplastic complications and cancers
Correlation, in a population of renal transplant patients followed in interregion Northwest, of the association of neoplastic complications after renal transplantation, skin cancers and solid tumors outside the non-Hodgkin's lymphoma and the terms of immunosuppressive treatment used
Measured: 10 years
Secondary outcomes (9)
Risk factors
Identify the main risk factors for developing cancer after transplantation, besides immunosuppressive therapy
Measured: 10 years
Incidence
Evaluate the incidence of neoplastic complications after renal transplantation in interregion Northwest
Measured: 10 years
Typology of cancers
Assess the distribution and respective frequency of different types of cancer, skin and solid tumors in this group of patients
Measured: 10 years
Survival prognosis
Establish the prognosis and survival of transplanted patients with a diagnosis of cancer after transplantation
Measured: 10 years
Survival factors
Analyze the factors associated with the survival of transplanted patients who developed cancer after transplantation
Measured: 10 years
Graft survival
Evaluate graft survival in the group of patients who develop post- transplantation cancer , especially after cancer diagnosis
Measured: 10 years
Rejection number
Determine the number of cellular acute rejection and humoral rejections in patients who developed cancer and those free from this complication and analyze the prevalence of releases in the period following the diagnosis of cancer
Measured: 10 years
Renal function after cancer
To analyze the evolution of renal function after cancer diagnosis
Measured: 10 years
Cancer management
Analyze the management of these cancers, in particular as regards the strategy of immunosuppressive therapy after cancer diagnosis
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study start17 Nov 2014
- Primary completion13 Nov 2021
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of KidneyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Caen, University Hospital, Lille, CHU ROUEN - HOPITAL DE BOIS-GUILLAUME
- Responsible party
- Sponsor
- Investigators
- Gabriel Choukroun, MD, PhD, Study director, CHU AmiensMarc Hazzan, MD, PhD, Study chair, CHRU LILLEBruno Hurault de Ligny, MD, PhD, Study chair, University Hospital, CaenMichel Godin, MD, PhD, Study chair, CHU Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121730
- Sponsor's protocol ID
- PI2012_843_0006
- Acronym
- FRISC
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2014
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pommerolle P, Assem M, Uhl M, De Sousa P, Guerrot D, Hazzan M, Lobbedez T, Fourdinier O, Choukroun G. Renal Cell Carcinoma in Native Kidney After Kidney Transplantation: A Multicenter Case Control Study With a Focus on Screening Strategy. Transpl Int. 2025 Jun 16;38:14487. doi: 10.3389/ti.2025.14487. eCollection 2025.
PubMed 40590038
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Key Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais, Normandy and Picardy Regions
- ClinicalTrials.gov ID
- NCT02121730
- Acronym / sponsor ID
- FRISC / PI2012_843_0006
- Conditions
- Cancer of Kidney
- Keywords
- grafting kidney, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- University Hospital, Caen, University Hospital, Lille, CHU ROUEN - HOPITAL DE BOIS-GUILLAUME
- Study start
- 17 Nov 2014 (actual)
- Primary completion
- 13 Nov 2021 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Kidney transplantation is now the treatment of choice for end-stage renal disease (ESRD). Between 2800 and 3000 kidney transplants are performed each year in France and more than 33 000 patients are living with a functioning graft.
Preventing allograft rejection requires the use of immunosuppressive therapy, the intensity decreases as the distance from the day of transplantation. Unfortunately, treatment favors certain complications, including infectious and neoplastic. These represent a major cause of mortality in these patients. If the frequency of skin cancer is greatly increased in this population, that of solid tumors remains a concern. Approximately 20% of patients develop cancer after 10 years of graft , half non- skin cancers, the main risk factor is immunosuppressive therapy .
The aim of the study is to evaluate, in a large population of patients treated in 4 regions ( the Nord-Pas de Calais, the Upper and Lower Normandy and Picardy) risk factors (in particular the nature of the immunosuppressive treatment) of developing a neoplastic complication, skin cancers and solid tumors, after renal transplantation.
Detailed description
A retrospective analysis of the previous 10 years, from 2002 to 2011 will be conducted. This study will better understand the epidemiology of these complications but also allow to identify risk factors associated, including demographic, environmental and related to immunosuppressive therapy.
Thereafter, we hope to implement preventive measures or prospective studies, allowing us to reduce the prevalence of this complication.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney Transplantation | – | –Patients who had undergone renal transplantation for 10 years in the interregion Northwest (Normandy, Picardy and Nord-Pas de Calais). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had undergone renal transplantation for 10 years in the French interregion Northwest (Normandy, Picardy and Nord-Pas de Calais).
Key inclusion criteria (6 listed)
- All adult renal transplant patients in the 4 centers of interregion North - West
- Patients transplanted during the period from 1 January 2002 and 31 December 2011
- Patients recipients of first, second or third renal transplantation
- Patients transplant recipients from a living or deceased donor whatever the immunological risk
- Eligible patients will be included after being informed by their doctor and after accepting their data to be processed in the framework of this study
Key exclusion criteria (5 listed)
- Patients transplanted as child
- Patients transplanted before 1 January 2002
- Patients followed in the interregion but transplanted in another center
- Patients recipients of a double transplant (two kidneys or kidney plus other organ)
- Patients that do not accept their medical data to be included in the database
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between neoplastic complications and cancers
Time frame: 10 years
Correlation, in a population of renal transplant patients followed in interregion Northwest, of the association of neoplastic complications after renal transplantation, skin cancers and solid tumors outside the non-Hodgkin's lymphoma and the terms of immunosuppressive treatment used
9 secondary outcomes
Risk factors
Time frame: 10 years
Incidence
Time frame: 10 years
Typology of cancers
Time frame: 10 years
Survival prognosis
Time frame: 10 years
Survival factors
Time frame: 10 years
Graft survival
Time frame: 10 years
Rejection number
Time frame: 10 years
Renal function after cancer
Time frame: 10 years
Cancer management
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Results publication: PubMed 40590038Pommerolle P, Assem M, Uhl M, De Sousa P, Guerrot D, Hazzan M, Lobbedez T, Fourdinier O, Choukroun G. Renal Cell Carcinoma in Native Kidney After Kidney Transplantation: A Multicenter Case Control Study With a Focus on Screening Strategy. Transpl Int. 2025 Jun 16;38:14487. doi: 10.3389/ti.2025.14487. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Choukroun, MD, PhD study director
CHU Amiens
Marc Hazzan, MD, PhD study chair
CHRU LILLE
Bruno Hurault de Ligny, MD, PhD study chair
University Hospital, Caen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Kidney, run by Centre Hospitalier Universitaire, Amiens at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between neoplastic complications and cancers (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.