Disorder Related to Renal TransplantationTRAKNCT02843763
Study of Specific CD4 Tumors Th1 Responses in Renal Transplant After Occurrence of Cancer
A study testing Blood sample in people with Disorder Related to Renal Transplantation and Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disorder Related to Renal Transplantation, Cancer
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2016to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Besançon University Hospital
Besançon, 25030
Emilie Gaiffe, Dr., 0381218824 ext. +33, egaiffe@chu-besancon.fr
Ingrid Tissot, 0381218427 ext. +33, itissot@chu-besancon.fr
About this study
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
- Being tested
- Blood sample
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Blood sample (28 ml)
| Study group | Role | What they receive |
|---|---|---|
| Renal transplant with 1rst cancer | Other | Renal transplant patients with first cancer (all cancer excepting skin cancer including in group 2).
Intervention : blood sample Receives: 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 Receives: 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 Receives: Other: Blood sample |
| RT with several skin cancer | Other | Renal transplant patients with several epidermoid skin cancer. Intervention : blood sample Receives: 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 Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
Th1 anti-hTERT cell serum levels 1C, 2A and 2B group
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start13 Jul 2016
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder Related to Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille, University Hospital, Tours
- Responsible party
- Sponsor
- Investigators
- Didier Ducloux, Pr., Principal investigator, Besancon University Hospital, Nephrology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843763
- Sponsor's protocol ID
- API/2015/59
- Acronym
- TRAK
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2016
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Specific CD4 Tumors Th1 Responses in Renal Transplant After Occurrence of Cancer
- ClinicalTrials.gov ID
- NCT02843763
- Acronym / sponsor ID
- TRAK / API/2015/59
- Conditions
- Disorder Related to Renal Transplantation, Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- University Hospital, Lille, University Hospital, Tours
- Study start
- 13 Jul 2016 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Renal transplant with 1rst cancer | Other | Other: Blood sampleRenal transplant patients with first cancer (all cancer excepting skin cancer including in group 2). Intervention : blood sample |
| Renal transplant patients without cancer | Other | Other: Blood sampleRenal transplant patients without cancer matched for age, transplantation duration and CMV/EBV status. Intervention : 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 | Other: Blood sampleRenal transplant patients with first epidermoid skin cancer. Intervention : blood sample |
| RT with several skin cancer | Other | Other: Blood sampleRenal transplant patients with several epidermoid skin cancer. Intervention : blood sample |
| Rt patients without cancer apparied to RT skin cancer | Other | Other: Blood sampleRenal transplant patients without cancer matched for age, transplantation duration and CMV/EBV status with renal transplant patients with skin cancer. Intervention : blood sample |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBlood sample (28 ml) | Other | 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 |
Primary outcome
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.
1 secondary outcome
Th1 anti-hTERT cell serum levels 1C, 2A and 2B group
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Ducloux, Pr. principal investigator
Besancon University Hospital, Nephrology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Disorder Related to Renal Transplantation and Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie Gaiffe, Dr. (0381218824 ext. +33, egaiffe@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Th1 anti-hTERT cell serum levels 1A and 1B group (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.