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出境医 / 临床实验 / Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation (SIA-CSH)
Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation (SIA-CSH)
Study Description
Brief Summary:
Description of the evolution of the biological characteristics of immune blood populations and biomarkers of interest in patients who have received allogeneic hematopoietic stem cell transplantation.
| Condition or disease | Intervention/treatment |
|---|---|
| Malignant Hemopathy | Other: Blood samples (additional tubes from care) longitudinal Other: Blood samples (additional tubes from care) at inclusion |
Detailed Description:
a more in-depth analysis of the different immune cell sub-populations as well as serum markers (cytokines) would provide a better understanding of post-allograft immune reconstitution mechanisms and identify potential immunologic biomarkers predictive of GVH or relapse.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 1020 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation |
| Actual Study Start Date : | May 14, 2019 |
| Estimated Primary Completion Date : | May 14, 2029 |
| Estimated Study Completion Date : | May 31, 2029 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Donor
In the case of a transplant from an intrafamily donor (genoid or haploid), we will also collect blood samples from the donor.
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Other: Blood samples (additional tubes from care) at inclusion
In the case of a transplant from an intrafamily donor (genoid or haploid), we will also collect blood samples from the donor. A single blood sample of 28 mL (7 EDTA tubes) will be made. In order not to represent an additional sample for the donor, this sample will be taken before the mobilization of the hematopoietic stem cells, during the biological assessment required for the biological donation qualification. |
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Receiver
Systematic longitudinal collection of blood samples for any patient receiving an allogeneic CSH transplant in our facility, regardless of donor category selected and type of graft used
|
Other: Blood samples (additional tubes from care) longitudinal
Some sampling times will be systematic, while others will only be performed in the presence of specific post-transplant clinical events (eg relapse, GVH ...).
|
Outcome Measures
Primary Outcome Measures :
- Evolution of the immune blood populations in patients who have received allogeneic hematopoietic stem cell transplantation. [ Time Frame: 5 years after HSC transplantation ]longitudinal study of the immune subpopulations of allografted patients for hematological malignancies.
Biospecimen Retention: Samples With DNA
Systematic longitudinal collection of blood samples for any patient receiving an allogeneic CSH transplant in our facility, regardless of donor category selected and type of graft used
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
The study population is male and / or female over 18 years of age with hematologic malignancies receiving allogeneic hematopoietic stem cell transplantation and corresponding donors.
Criteria
Inclusion Criteria:
- Allogeneic hematopoietic stem cell transplant for hematological malignancy
- Patients 18 years of age or older
- Signed consent to participation
- Membership in a social security scheme, or beneficiary of such a scheme.
Exclusion Criteria:
- A person of legal age subject to a legal protection measure (major under guardianship, curatorship or court bail), or unable to express consent (language criteria included).
Contacts and Locations
Contacts
| Contact: Dominique Genre, MD | 0491223778 | drci.up@ipc.unicancer.fr | |
| Contact: Margot Berline, MSc, MBA | 0491223314 | drci.up@ipc.unicancer.fr |
Locations
| France | |
| Institut Paoli-Calmettes | Recruiting |
| Marseille, Bouches-du Rhône, France, 13009 | |
| Contact: Dominique GENRE, MD +33 4 91 22 37 78 drci.up@ipc.unicancer.fr | |
| Principal Investigator: Raynier DEVILLIER | |
Sponsors and Collaborators
Institut Paoli-Calmettes
INSERM-U1068
Investigators
| Principal Investigator: | Raynier Devillier, MD, PhD | Institut Paoli-Calmettes |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 16, 2019 | ||||||||
| First Posted Date | May 29, 2019 | ||||||||
| Last Update Posted Date | May 29, 2019 | ||||||||
| Actual Study Start Date | May 14, 2019 | ||||||||
| Estimated Primary Completion Date | May 14, 2029 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Evolution of the immune blood populations in patients who have received allogeneic hematopoietic stem cell transplantation. [ Time Frame: 5 years after HSC transplantation ] longitudinal study of the immune subpopulations of allografted patients for hematological malignancies.
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation | ||||||||
| Official Title | Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation | ||||||||
| Brief Summary | Description of the evolution of the biological characteristics of immune blood populations and biomarkers of interest in patients who have received allogeneic hematopoietic stem cell transplantation. | ||||||||
| Detailed Description | a more in-depth analysis of the different immune cell sub-populations as well as serum markers (cytokines) would provide a better understanding of post-allograft immune reconstitution mechanisms and identify potential immunologic biomarkers predictive of GVH or relapse. | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
Systematic longitudinal collection of blood samples for any patient receiving an allogeneic CSH transplant in our facility, regardless of donor category selected and type of graft used
|
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | The study population is male and / or female over 18 years of age with hematologic malignancies receiving allogeneic hematopoietic stem cell transplantation and corresponding donors. | ||||||||
| Condition | Malignant Hemopathy | ||||||||
| Intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
1020 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | May 31, 2029 | ||||||||
| Estimated Primary Completion Date | May 14, 2029 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03965429 | ||||||||
| Other Study ID Numbers | SIA-CSH-IPC 2015-017 2019-000814-13 ( EudraCT Number ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Institut Paoli-Calmettes | ||||||||
| Study Sponsor | Institut Paoli-Calmettes | ||||||||
| Collaborators | INSERM-U1068 | ||||||||
| Investigators |
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| PRS Account | Institut Paoli-Calmettes | ||||||||
| Verification Date | May 2019 | ||||||||
