Immune Reconstitution and Clinical Prognosis Following Umbilical Cord Blood Transplantation
A Prospective Study on Immune Reconstitution and Clinical Prognosis in Patients After Umbilical Cord Blood Transplantation
In this prospective randomized controlled trial of umbilical cord blood hematopoietic stem cell transplant recipients, post-transplant immune data will be collected from two groups. A composite immune risk score will be used to assess immune reconstitution for risk stratification and analyze its associations with clinical prognostic endpoints.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Yahui Feng
- Telefonnummer: 022-23608045
- E-post: fengyahui@ihcams.ac.cn
Studieorter
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-
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Tianjin, Kina
- Rekrytering
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
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Kontakt:
- Yahui Feng
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age ≥ 14 years old
- Umbilical cord blood transplant
- Patients must provide written informed consent before the start of the study procedures.
Exclusion Criteria:
- Patients who are ineligible for the study due to other factors, or who will bear great risk if they participate in the study.
- Death or loss to follow-up of the patient prior to immune reconstitution stratification
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Composite Immune Risk Score Stratification Notification Group
Attending physicians will receive immune reconstitution risk stratification results of patients calculated by the composite immune risk score model to guide patient health monitoring. |
Attending physicians will receive immune reconstitution risk stratification results of patients calculated by the composite immune risk score model to guide patient health monitoring. |
|
Inget ingripande: Standard Care Control Group
No risk stratification results of patients from the composite immune risk score model will be provided to attending physicians. Patients receive standard routine care. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Frequency of infection-related laboratory testing (blood culture, pathogen PCR, NGS)
Tidsram: 6 months post-transplant
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Defined as the count of infection-related laboratory tests (blood culture, pathogen PCR, pathogen NGS) for each patient within 6 months after umbilical cord blood transplantation. Test counts are extracted from electronic medical records. |
6 months post-transplant
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Number of medication adjustments intended to accelerate immune reconstitution or enhance infection prophylaxis
Tidsram: 6 months post-transplant
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6 months post-transplant
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Number of return visits
Tidsram: 6 months post-transplant
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6 months post-transplant
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Frequency of infection-related laboratory testing (blood culture, pathogen PCR, NGS)
Tidsram: 1 year post-transplant
|
Defined as the count of infection-related laboratory tests (blood culture, pathogen PCR, pathogen NGS) for each patient within 1 year after umbilical cord blood transplantation. Test counts are extracted from electronic medical records. |
1 year post-transplant
|
|
Number of medication adjustments intended to accelerate immune reconstitution or enhance infection prophylaxis
Tidsram: 1 year post-transplant
|
1 year post-transplant
|
|
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Number of return visits
Tidsram: 1 year post-transplant
|
1 year post-transplant
|
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Immune reconstitution status (quantity of T, B, NK cells and other immune subsets, and T cell clonal diversity)
Tidsram: at 4, 6, 9 and 12 months post-transplant
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Defined as the quantity of T cells, B cells, NK cells and other immune subsets measured by flow cytometry, and T cell clonal diversity assessed by TCR repertoire sequencing at scheduled time points. Data are extracted from electronic medical records. |
at 4, 6, 9 and 12 months post-transplant
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Infection rate
Tidsram: at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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Incidence of chronic GVHD
Tidsram: at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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Relapse rate
Tidsram: at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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Survival
Tidsram: at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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Hospitalization rate
Tidsram: at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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Outpatient rate
Tidsram: at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- SKIRT-CB-RCT-001
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