Hematopoietic Stem Cell TransplantationNCT06484049
Prospective Observational Clinical Study on Changes in Cognitive Levels in Elderly Patients Before and After Hematopoietic Stem Cell Transplantation
An observational study of Hematopoietic Stem Cell Transplantation, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2024to 31 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age greater than or equal to 55 years; Patients planning to undergo allogeneic hematopoietic stem cell transplantation.
Who may be able to join
- Age greater than or equal to 55 years;
- Patients planning to undergo allogeneic hematopoietic stem cell transplantation.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Hematopoietic Stem Cell Transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start30 Jul 2024 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484049
- Sponsor's protocol ID
- IIT2024042
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Clinical Study on Changes in Cognitive Levels in Elderly Patients Before and After Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06484049
- Acronym / sponsor ID
- IIT2024042
- Conditions
- Hematopoietic Stem Cell Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 30 Jul 2024 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age greater than or equal to 55 years; Patients planning to undergo allogeneic hematopoietic stem cell transplantation.
Key inclusion criteria (2 listed)
- Age greater than or equal to 55 years;
- Patients planning to undergo allogeneic hematopoietic stem cell transplantation.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To observe changes in cognitive levels in patients aged ≥55 years receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT) before and after allo-HSCT.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic Stem Cell Transplantation, run by Institute of Hematology & Blood Diseases Hospital, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact erlie jiang (+86-15122538106, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To observe changes in cognitive levels in patients aged ≥55 years receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT) before and after allo-HSCT. (time frame: 1YEAR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.