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

Cancer Clinical Trial

— TRAK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02843763
• Other study ID #: API/2015/59
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2016
• Est. completion date: September 2022

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Emilie Gaiffe, Dr.
• Phone: 0381218824
• Email: egaiffe[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Disorder Related to Renal Transplantation

Intervention

Other:
• Blood sample
Blood sample (28 ml)

Locations

Country	Name	City	State
France	Besançon University Hospital	Besançon

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	University Hospital, Lille, University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Th1 anti-hTERT cell serum levels 1A and 1B group	Th1 anti-hTERT cell levels measured in blood by IFN-? ELISpot in renal transplant patients developing cancer versus first with renal transplant patients without cancer.	1 day
Secondary	Th1 anti-hTERT cell serum levels 1C, 2A and 2B group	Th1anti-hTERT cell levels measured in blood by IFN-? ELISpot in patients developing a first or recurrent squamous cell carcinoma compared with renal transplant patients without cancer.	1 day