NCT06946654

Brief Summary

This comprehensive, multidimensional evaluation assesses patient-related factors, disease-related factors, donor-related factors, and treatment-related factors. The study aims to identify potential risk factors influencing transplant outcomes in elderly patients and enhance the outcomes of allo-HSCT.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
May 2025Mar 2027

First Submitted

Initial submission to the registry

April 19, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

May 20, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

April 19, 2025

Last Update Submit

May 9, 2025

Conditions

ElderlyGeriatric AssessmentALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION

Keywords

elderlyGeriatric Assessmentallo-HSCT

Outcome Measures

Primary Outcomes (1)

  • Transplant-related mortality

    Transplant-related mortality (TRM) is defined as death due to any transplantation-related cause other than disease relapse. Transplant-related mortality will be calculated using a competing risks model.

    From HSCT to the follow-up assessment at 12 months post-treatment.

Secondary Outcomes (6)

  • Engraftment

    From HSCT to the follow-up assessment at 12 months post-treatment.

  • GVHD

    From HSCT to the follow-up assessment at 12 months post-treatment.

  • Overall Survival

    From HSCT to the follow-up assessment at 12 months post-treatment.

  • Cumulative Incidence of Relapse

    From HSCT to the follow-up assessment at 12 months post-treatment.

  • Disease-Free Survival

    From HSCT to the follow-up assessment at 12 months post-treatment.

  • +1 more secondary outcomes

Study Arms (1)

Geriatric Assessment

Procedure: Geriatric Assessment

Interventions

Geriatric AssessmentPROCEDURE

This is a study held in all patients undergoing allogenic hematopoietic stem cell transplantation. Pre-transplant assessment: (1)Patients-related assessment: (a) Age; (b) Functional status (BADL score; IADL score; KPS score; ECOG PS score); (c) Comorbidities (HCT-CI score); (d) Nutritional Status (Body weight; BMI; NRS-2002; MNA-SF; MUST); (e) Psychological Status (SF36-MCS; GDS; PHQ-9; GAD-7); (f) Cognitive Function (MMSE; BMOC); (g) Social Support Level (MOS-SSS; MSPSS); (h) Total Number of Medications Used. (2) Disease-Related Factors Assessment: Primary Disease Diagnosis; ELN Risk Stratification (assessed only for AML patients); Disease Status. (3) Donor-Related Factors Assessment: Donor Age; Donor Sex; Donor-Recipient Blood Type Compatibility; Donor Type; DSA. (4) Treatment-Related Factors Assessment: Conditioning Regimen; GVHD Prophylaxis Regimen; Graft Type.

Geriatric Assessment

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients with hematologic disorders with established indications for transplantation, including malignant and non-malignant hematologic diseases.

You may qualify if:

  • (a)Age ≥55 years.
  • (b)Hematologic disorders with established indications for transplantation, including malignant and non-malignant hematologic diseases. (c)Willingness to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Interventions

Geriatric Assessment

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth StatusDemographyPopulation CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Central Study Contacts

Yuqian Sun

CONTACT

861088326666sunyuqian83@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 19, 2025

First Posted

April 27, 2025

Study Start

May 20, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

May 11, 2025

Record last verified: 2025-05

Locations

CN(1)