Organ TransplantationNCT04687865
Constitution of a Biobank for Studies Related to Organ Transplantation (Lyon Centaure Biocollection)
An observational study of Organ Transplantation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This study aims to constitute a collection of biological materials from in transplant patients and to provide biological materials from transplanted patients in order : i) validate new theory on the cause of allograft loss, ii) develop innovative biomarker for rejection and other transplantation-related conditions… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Transplantation
- What is being tested?
- Biobank
- How many people
- 4,000 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2020to 8 Jan 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: All adult patients that received a solid organ transplant at the transplantation department of Lyon University Hospital
Who may be able to join
- Male or Female patient ≥18 years old
- Recipient of an organ transplant
- Written informed consent
Who cannot join
- Non-affiliation to a social security system.
- Subjects deprived of liberties
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Edouard Herriot
Lyon, Rhône, 69003
Olivier THAUNAT, MD, 04.72.11.69.28 ext. +33, olivier.thaunat@chu-lyon.fr
DANIEL SPERANDO, CRA, 04.72.11.69.28 ext. +33, daniel.sperando@chu-lyon.fr
About this study
Official title: Biological Material Bank for Studies Related to Organ Transplantation
This study aims to constitute a collection of biological materials from in transplant patients and to provide biological materials from transplanted patients in order :
- validate new theory on the cause of allograft loss, ii) develop innovative biomarker for rejection and other transplantation-related conditions (such as BK virus nephropathy, Post-transplant lymphoproliferative disorder ( PTLD) ...)
- Conditions
- Organ Transplantation
- Being tested
- Biobank
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiobankOther
For each patient included in the study the following samples will be collected at the indicated time points after transplantation:
- Serum samples and plasma sample: Day1, Month 1, Month 3, Month 6, Month 12, month 60, month 120 and at the time of each allograft biopsy.
- Urines samples: Month 3 and Month 12 and at the time of each allograft biopsy.
- Peripheral Blood Mononuclear Cell (PBMC): for each organ allograft biopsy.
- Allograft biopsies: systematically at Month 3, and Month 12, and for cause in case of allograft dysfunction.
What is being measured
The primary outcome is the main question the study is designed to answer.
the biological samples
The goal of this study is to provide biological materials from transplanted patients
Measured: At inclusion
Change Biological Samples
The goal of this study is to provide biological materials from transplanted patients
Measured: Month 1
Change Biological Samples
The goal of this study is to provide biological materials from transplanted patients
Measured: Month 3
Change Biological Samples
The goal of this study is to provide biological materials from transplanted patients
Measured: Month 6
Change Biological Samples
The goal of this study is to provide biological materials from transplanted patients
Measured: Month 12
Change Biological Samples
The goal of this study is to provide biological materials from transplanted patients
Measured: Month 60
Change Biological Samples
The goal of this study is to provide biological materials from transplanted patients
Measured: Month 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start8 Jan 2020
- Primary completion8 Jan 2040 (estimated)
- Study completion8 Jan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ TransplantationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Thaunat, MD, Principal investigator, Edouard Herriot Hospital - Transplantation department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687865
- Sponsor's protocol ID
- 69HCL20_0964
- Status last verified
- Mar 2025
- First submitted
- 16 Dec 2020
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Material Bank for Studies Related to Organ Transplantation
- ClinicalTrials.gov ID
- NCT04687865
- Acronym / sponsor ID
- 69HCL20_0964
- Conditions
- Organ Transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 8 Jan 2040 (estimated)
- Study completion
- 8 Jan 2040 (estimated)
- First posted
- 29 Dec 2020 (actual)
- 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.
This study aims to constitute a collection of biological materials from in transplant patients and to provide biological materials from transplanted patients in order :
- validate new theory on the cause of allograft loss, ii) develop innovative biomarker for rejection and other transplantation-related conditions (such as BK virus nephropathy, Post-transplant lymphoproliferative disorder ( PTLD) ...)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult patients that received a solid organ transplant at the transplantation department of Lyon University Hospital
Key inclusion criteria (3 listed)
- Male or Female patient ≥18 years old
- Recipient of an organ transplant
- Written informed consent
Key exclusion criteria (3 listed)
- Non-affiliation to a social security system.
- Subjects deprived of liberties
- Pregnant or breastfeeding woman
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 |
|---|---|---|
| BiobankFor each patient included in the study the following samples will be collected at the indicated time points after transplantation: * Serum samples and plasma sample: Day1, Month 1, Month 3, Month 6, Month 12, month 60, month 120 and at the time of each allograft biopsy. * Urines samples: Month 3 and Month 12 and at the time of each allograft biopsy. * Peripheral Blood Mononuclear Cell (PBMC): for each organ allograft biopsy. * Allograft biopsies: systematically at Month 3, and Month 12, and for cause in case of allograft dysfunction. | Other | – |
Primary outcome
the biological samples
Time frame: At inclusion
The goal of this study is to provide biological materials from transplanted patients
Change Biological Samples
Time frame: Month 1
The goal of this study is to provide biological materials from transplanted patients
Change Biological Samples
Time frame: Month 3
The goal of this study is to provide biological materials from transplanted patients
Change Biological Samples
Time frame: Month 6
The goal of this study is to provide biological materials from transplanted patients
Change Biological Samples
Time frame: Month 12
The goal of this study is to provide biological materials from transplanted patients
Change Biological Samples
Time frame: Month 60
The goal of this study is to provide biological materials from transplanted patients
Change Biological Samples
Time frame: Month 120
The goal of this study is to provide biological materials from transplanted patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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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.
Olivier Thaunat, MD principal investigator
Edouard Herriot Hospital - Transplantation department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Organ Transplantation, run by Hospices Civils de Lyon 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 7 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier Thaunat, MD (04 72 11 69 28 ext. +33, olivier.thaunat@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the biological samples (time frame: At inclusion). The study lists 7 primary outcomes in all. 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 7 Mar 2025.