Study of Specific CD4 Tumors Th1 Responses in Renal Transplant After Occurrence of Cancer (NCT02843763) | Clinical Trial Compass
UnknownNot Applicable
Study of Specific CD4 Tumors Th1 Responses in Renal Transplant After Occurrence of Cancer
France70 participantsStarted 2016-07-13
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Th1 anti-hTERT cell serum levels 1A and 1B group
Timeframe: 1 day
Trial details
NCT IDNCT02843763
SponsorCentre Hospitalier Universitaire de Besancon