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Study of Specific CD4 Tumors Th1 Responses in Renal Transplant After Occurrence of Cancer (TRAK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02843763
Recruitment Status : Recruiting
First Posted : July 26, 2016
Last Update Posted : February 11, 2020
Sponsor:
Collaborators:
University Hospital, Lille
University Hospital, Tours
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:

As early complications of transplantation (acute rejection and infections) were better controlled and that the survival of kidney transplants has increased, chronic complications of immunosuppression became increasing challenges. The incidence of cancer is greatly increased in transplant and cancer is now the first cause of death. The iatrogenic immunosuppression plays a major role in the increased incidence of cancer. If it is accepted that the incidence of cancer is generally increased after transplantation, the increased risk is very different from a specific cancer to another. Furthermore the specific treatment of the tumor (surgery, radiotherapy, chemotherapy, biotherapy), the specificity of the context of transplantation is related to the possibility of modulation of immunosuppression. However, there is no immunological marker for predicting the effectiveness of a modification of the immunosuppression.

Several studies point to the important role of CD4 T cells into Th1 anti-tumor immunosurveillance group cancers. Identified "helper" degenerate peptides, called Universal Cancer Peptide (UCP) derivative of telomerase, a type of tumor antigen universal. These UCP peptides bind most HLA-DR alleles most frequent of the population and have the particularity of specifically stimulate CD4 T cells of type Th1. Using a test based on the UCP, it possible to detect the presence of spontaneous CD4 Th1 anti-UCP answers in several types of human cancers.

The main objective of this study is to determine whether, in renal transplant patients, the occurrence of cancer is associated with a deficiency of CD4 Th1 response anti-hTERT.


Condition or disease Intervention/treatment Phase
Disorder Related to Renal Transplantation Cancer Other: Blood sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Study of Specific CD4 Tumors Th1 Responses in Renal Transplant After Occurrence of Cancer
Actual Study Start Date : July 13, 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Renal transplant with 1rst cancer

Renal transplant patients with first cancer (all cancer excepting skin cancer including in group 2).

Intervention : blood sample

Other: Blood sample
Blood sample (28 ml)

Renal transplant patients without cancer

Renal transplant patients without cancer matched for age, transplantation duration and CMV/EBV status.

Intervention : blood sample

Other: Blood sample
Blood sample (28 ml)

No Intervention: Patient with cancer
Patient with cancer from oncology departement matched for cancer type and stade and CMV/EBV status.
Renal transplant with first skin cancer
Renal transplant patients with first epidermoid skin cancer. Intervention : blood sample
Other: Blood sample
Blood sample (28 ml)

RT with several skin cancer
Renal transplant patients with several epidermoid skin cancer. Intervention : blood sample
Other: Blood sample
Blood sample (28 ml)

Rt patients without cancer apparied to RT skin cancer

Renal transplant patients without cancer matched for age, transplantation duration and CMV/EBV status with renal transplant patients with skin cancer.

Intervention : blood sample

Other: Blood sample
Blood sample (28 ml)




Primary Outcome Measures :
  1. Th1 anti-hTERT cell serum levels 1A and 1B group [ Time Frame: 1 day ]
    Th1 anti-hTERT cell levels measured in blood by IFN-γ ELISpot in renal transplant patients developing cancer versus first with renal transplant patients without cancer.


Secondary Outcome Measures :
  1. Th1 anti-hTERT cell serum levels 1C, 2A and 2B group [ Time Frame: 1 day ]
    Th1anti-hTERT cell levels measured in blood by IFN-γ ELISpot in patients developing a first or recurrent squamous cell carcinoma compared with renal transplant patients without cancer.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged 18 to 80 years included
  • Signature of informed consent for participation indicating that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study
  • Join a French social security or receiving such a plan
  • Group 1A: renal transplant patients reporting a first cancer (all types of cancer except skin inclued in group 2A or 2B)
  • Group 1B: renal transplant patients without cancer (matched to patients in group 1A)
  • 1C Group: Non transplant patients reporting a first cancer (patients matched to Group 1A for the type and stage of cancer and the status CMV / EBV)
  • Group 2A: kidney transplant patients reporting a single squamous cell carcinoma
  • Group 2B: kidney transplant patients with multiple recurrences of squamous cell carcinomas.
  • Group 2C: renal transplant patients without cancer (matched to patients in group 2A and 2B)

Exclusion Criteria:

  • Legal incapacity or limited legal capacity
  • Topic unlikely to cooperate in the study and / or low early cooperation by the investigator
  • Without health insurance Topic
  • Pregnant woman
  • Inability to understand the reasons for the study; psychiatric disorders judged by the investigator to be incompatible with the inclusion in the study
  • Active infection or not by HIV

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): NCT02843763


Contacts
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Contact: Emilie Gaiffe, Dr. 0381218824 ext +33 egaiffe@chu-besancon.fr
Contact: Ingrid Tissot 0381218427 ext +33 itissot@chu-besancon.fr

Locations
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France
Besançon University Hospital Recruiting
Besançon, France, 25030
Contact: Emilie Gaiffe, Dr.    0381218824 ext +33    egaiffe@chu-besancon.fr   
Contact: Ingrid Tissot    0381218427 ext +33    itissot@chu-besancon.fr   
Principal Investigator: Didier Ducloux, Pr.         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
University Hospital, Lille
University Hospital, Tours
Investigators
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Principal Investigator: Didier Ducloux, Pr. Besancon University Hospital, Nephrology department
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02843763    
Other Study ID Numbers: API/2015/59
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No