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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Yahui Feng
- Telefonnummer: 022-23608045
- E-post: fengyahui@ihcams.ac.cn
Studiesteder
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Tianjin, Kina
- Rekruttering
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
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Ta kontakt med:
- Yahui Feng
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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. |
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Ingen inngripen: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Frequency of infection-related laboratory testing (blood culture, pathogen PCR, NGS)
Tidsramme: 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
Tidsramme: 6 months post-transplant
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6 months post-transplant
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Number of return visits
Tidsramme: 6 months post-transplant
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6 months post-transplant
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Frequency of infection-related laboratory testing (blood culture, pathogen PCR, NGS)
Tidsramme: 1 year 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 1 year after umbilical cord blood transplantation. Test counts are extracted from electronic medical records. |
1 year post-transplant
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Number of medication adjustments intended to accelerate immune reconstitution or enhance infection prophylaxis
Tidsramme: 1 year post-transplant
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1 year post-transplant
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Number of return visits
Tidsramme: 1 year post-transplant
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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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- SKIRT-CB-RCT-001
Legemiddel- og utstyrsinformasjon, studiedokumenter
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