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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02843763
Acronym
TRAK
Enrollment
70
Registered
2016-07-26
Start date
2016-07-13
Completion date
2022-09-30
Last updated
2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Disorder Related to Renal Transplantation

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.

Interventions

OTHERBlood sample

Blood sample (28 ml)

Sponsors

University Hospital, Lille
CollaboratorOTHER
University Hospital, Tours
CollaboratorOTHER
Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Th1 anti-hTERT cell serum levels 1A and 1B group1 dayTh1 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

MeasureTime frameDescription
Th1 anti-hTERT cell serum levels 1C, 2A and 2B group1 dayTh1anti-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.

Countries

France

Contacts

Primary ContactEmilie Gaiffe, Dr.
egaiffe@chu-besancon.fr0381218824
Backup ContactIngrid Tissot
itissot@chu-besancon.fr0381218427

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026