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

NCT02843763 | Unknown

• 1 other identifier: API/2015/59
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder Related to Renal Transplantation; Cancer

Outcome Measures

Primary Outcomes (1)

• Th1 anti-hTERT cell serum levels 1A and 1B group

  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.

  1 day

Secondary Outcomes (1)

• Th1 anti-hTERT cell serum levels 1C, 2A and 2B group

  1 day

Study Arms (6)

Renal transplant with 1rst cancer

OTHER

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

Other: Blood sample

Renal transplant patients without cancer

OTHER

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

Other: Blood sample

Patient with cancer

NO INTERVENTION

Patient with cancer from oncology departement matched for cancer type and stade and CMV/EBV status.

Renal transplant with first skin cancer

OTHER

Renal transplant patients with first epidermoid skin cancer. Intervention : blood sample

Other: Blood sample

RT with several skin cancer

OTHER

Renal transplant patients with several epidermoid skin cancer. Intervention : blood sample

Other: Blood sample

Rt patients without cancer apparied to RT skin cancer

OTHER

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

Interventions

Blood sample OTHER

Blood sample (28 ml)

RT with several skin cancer; Renal transplant patients without cancer; Renal transplant with 1rst cancer; Renal transplant with first skin cancer; Rt patients without cancer apparied to RT skin cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• C 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)

You may not qualify if:

• 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
• Active infection or not by HIV

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• University Hospital, Lille: collaborator
• University Hospital, Tours: collaborator

Study Sites (1)

Besançon University Hospital

Besançon, 25030, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Didier Ducloux, Pr.

  Besancon University Hospital, Nephrology department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie Gaiffe, Dr.

CONTACT

0381218824; egaiffe@chu-besancon.fr

Ingrid Tissot

CONTACT

0381218427; itissot@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 26, 2016
• Study Start: July 13, 2016
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)