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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Yahui Feng
- Telefonnummer: 022-23608045
- E-Mail: fengyahui@ihcams.ac.cn
Studienorte
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Tianjin, China
- Rekrutierung
- 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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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Kein Eingriff: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Frequency of infection-related laboratory testing (blood culture, pathogen PCR, NGS)
Zeitfenster: 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
Zeitfenster: 6 months post-transplant
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6 months post-transplant
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Number of return visits
Zeitfenster: 6 months post-transplant
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6 months post-transplant
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Frequency of infection-related laboratory testing (blood culture, pathogen PCR, NGS)
Zeitfenster: 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
Zeitfenster: 1 year post-transplant
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1 year post-transplant
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Number of return visits
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: at 6, 9 and 12 months post-transplant
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at 6, 9 and 12 months post-transplant
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- SKIRT-CB-RCT-001
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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