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

NCT06484049 | Not Yet Recruiting

• 1 other identifier: IIT2024042
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

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

  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.

  1YEAR

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Central Study Contacts

erlie jiang

CONTACT

+86-15122538106; jiangerlie@ihcams.ac.cn

yigeng cao

CONTACT

+86-18622477066; caoyigeng@ams.ac.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: July 3, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: July 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share