Prospective Observational Clinical Study on Changes in Cognitive Levels in Elderly Patients Before and After Hematopoietic Stem Cell Transplantation

Not yet recruiting

• Conditions: Hematopoietic Stem Cell Transplantation

• Registration Number: NCT06484049
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief Summary

To investigate the potential improvement in cognitive levels in elderly individuals following hematopoietic stem cell transplantation, which will help better understand the changes in cognitive levels after transplantation in elderly patients, providing crucial reference for future clinical practice and research.

Detailed Description

To investigate the potential improvement in cognitive levels in elderly individuals following hematopoietic stem cell transplantation, which will help better understand the changes in cognitive levels after transplantation in elderly patients, providing crucial reference for future clinical practice and research.

To observe changes in cognitive levels in patients aged ≥55 years receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT) before and after allo-HSCT.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-28
• Study First Posted: 2024-07-03
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25
• Study Start: 2024-07-30
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age greater than or equal to 55 years;
2. Patients planning to undergo allogeneic hematopoietic stem cell transplantation.

Exclusion Criteria

1. Patients with active diseases;
2. Presence of central nervous system tumor invasion;
3. Planning to undergo two or more transplantations;
4. Severe cognitive impairments or mental illnesses;
5. Inability to communicate in Mandarin.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To observe changes in cognitive levels in patients aged ≥55 years receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT) before and after allo-HSCT.	1YEAR	1.Post-transplant Assessment: Cognitive level follow-up assessments at 1 month, 3 months, 6 months, and 1 year post-operation. Evaluation content is consistent with pre-transplant assessments. Cerebrospinal fluid testing is scheduled for 3 months post-transplant.4. Survival and Disease Follow-up: Follow-up for one year after transplantation to observe overall survival rate, disease-free survival rate, etc.