Hematopoietic and Lymphoid Cell NeoplasmNCT04892823
Social Relationships and Accelerated Aging in Hematopoietic Cell Transplant Survivors
An observational study of Hematopoietic and Lymphoid Cell Neoplasm, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This project aims to elucidate the important protective elements of social relationships and identify concrete, modifiable behavioral factors that contribute to biological and phenotypic aging in hematopoietic cell transplantation (HCT) survivors and can be used to develop biologically informed interventions to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm
- What is being tested?
- Biospecimen Collection, Electronic Health Record Review and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2021to 16 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing HCT for hematologic cancers.
Who may be able to join
- Aged 18 years and older who are competent to give their informed consent.
- Ability to read, speak, and understand English.
- Received a hematopoietic cell transplant within the previous 100 days.
Who cannot join
- Less then Aged 18 years and older who are competent to give their informed consent.
- Cannot read, speak, and understand English.
- Has not received a hematopoietic cell transplant within the previous 100 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
United States1 site, 1 recruiting
- Recruiting
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Kelly Rentscher, PhD, 414-955-8990, krentscher@mcw.edu
Kelly Rentscher, PhD
About this study
Official title: Accelerated Biological and Phenotypic Aging in Hematopoietic Cell Transplant Survivors: Social Support as a Protective Factor
This project aims to elucidate the important protective elements of social relationships and identify concrete, modifiable behavioral factors that contribute to biological and phenotypic aging in hematopoietic cell transplantation (HCT) survivors and can be used to develop biologically informed interventions to improve quality of life and prolong the healthspan of individuals with accelerated aging.
Read the detailed description
PRIMARY OBJECTIVES:
- Examine associations between social support, strain, and isolation and phenotypic aging over the 1-year recovery period.
II. Examine associations between social support, strain, and isolation and biological aging over the 1-year recovery period.
III. Test biological aging as a mediator linking social processes and phenotypic aging.
EXPLORATORY OBJECTIVE:
- Test sex differences in Aims 1 and 2.
OUTLINE:
Adopting a prospective design, participants will complete comprehensive assessments of social processes at 100 days and 1 year after HCT that combine reports of social support, strain, and isolation with a naturalistic observation tool, the Electronically Activated Recorder (EAR), which captures ambient sound bites to assess social interactions in survivors' daily lives16. At each time point, participants will also provide reports of symptoms to characterize phenotypic aging, including cognitive, physical, and functional complaints, and blood samples to assess biological aging, including cellular senescence, DNA damage, SASP, and cellular stress using genome-wide RNA sequencing. Relevant clinical information that could influence biological aging will also be collected from patients' medical records to consider as covariates.
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Being tested
- Biospecimen Collection, Electronic Health Record Review, Questionnaire Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood sample
Electronic Health Record ReviewOther
Review of medical records
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (EAR, questionnaires, biospecimen collection) | Participants will complete comprehensive assessments of social processes at 100 days and 1 year after HCT that combine reports of social support, strain, and isolation with a naturalistic observation tool, the Electronically Activated Recorder (EAR), which captures ambient sound bites to assess social interactions in survivors' daily lives. At each time point, participants will also provide reports of symptoms to characterize phenotypic aging, including cognitive, physical, and functional complaints, and blood samples to assess biological aging, including cellular senescence, DNA damage, SASP, and cellular stress using genome wide RNA sequencing. Relevant clinical information that could influence biological aging will also be collected from patients' medical records to consider as covariates. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with gene expression of cellular senescence marker p16.
This will be measured by mRNA/gene expression.
Measured: Day 100 and 1 year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start18 May 2021
- Primary completion16 Jul 2027 (estimated)
- Study completion16 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kelly E Rentscher, PhD, Medical College of Wisconsin
- Investigators
- Kelly Rentscher, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892823
- Sponsor's protocol ID
- 43000
- Other IDs
- NCI-2021-02616, 43000, K01AG065485
- Status last verified
- Aug 2026
- First submitted
- 10 May 2021
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Biological and Phenotypic Aging in Hematopoietic Cell Transplant Survivors: Social Support as a Protective Factor
- ClinicalTrials.gov ID
- NCT04892823
- Acronym / sponsor ID
- 43000
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 18 May 2021 (actual)
- Primary completion
- 16 Jul 2027 (estimated)
- Study completion
- 16 Jul 2027 (estimated)
- First posted
- 19 May 2021 (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.
This project aims to elucidate the important protective elements of social relationships and identify concrete, modifiable behavioral factors that contribute to biological and phenotypic aging in hematopoietic cell transplantation (HCT) survivors and can be used to develop biologically informed interventions to improve quality of life and prolong the healthspan of individuals with accelerated aging.
Detailed description
PRIMARY OBJECTIVES:
- Examine associations between social support, strain, and isolation and phenotypic aging over the 1-year recovery period.
II. Examine associations between social support, strain, and isolation and biological aging over the 1-year recovery period.
III. Test biological aging as a mediator linking social processes and phenotypic aging.
EXPLORATORY OBJECTIVE:
- Test sex differences in Aims 1 and 2.
OUTLINE:
Adopting a prospective design, participants will complete comprehensive assessments of social processes at 100 days and 1 year after HCT that combine reports of social support, strain, and isolation with a naturalistic observation tool, the Electronically Activated Recorder (EAR), which captures ambient sound bites to assess social interactions in survivors' daily lives16. At each time point, participants will also provide reports of symptoms to characterize phenotypic aging, including cognitive, physical, and functional complaints, and blood samples to assess biological aging, including cellular senescence, DNA damage, SASP, and cellular stress using genome-wide RNA sequencing. Relevant clinical information that could influence biological aging will also be collected from patients' medical records to consider as covariates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (EAR, questionnaires, biospecimen collection) | – | Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Other: Questionnaire AdministrationParticipants will complete comprehensive assessments of social processes at 100 days and 1 year after HCT that combine reports of social support, strain, and isolation with a naturalistic observation tool, the Electronically Activated Recorder (EAR), which captures ambient sound bites to assess social interactions in survivors' daily lives. At each time point, participants will also provide reports of symptoms to characterize phenotypic aging, including cognitive, physical, and functional complaints, and blood samples to assess biological aging, including cellular senescence, DNA damage, SASP, and cellular stress using genome wide RNA sequencing. Relevant clinical information that could influence biological aging will also be collected from patients' medical records to consider as covariates. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing HCT for hematologic cancers.
Key inclusion criteria (3 listed)
- Aged 18 years and older who are competent to give their informed consent.
- Ability to read, speak, and understand English.
- Received a hematopoietic cell transplant within the previous 100 days.
Key exclusion criteria (3 listed)
- Less then Aged 18 years and older who are competent to give their informed consent.
- Cannot read, speak, and understand English.
- Has not received a hematopoietic cell transplant within the previous 100 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood sample | Procedure or surgery | Supportive care (EAR, questionnaires, biospecimen collection) |
| Electronic Health Record ReviewReview of medical records | Other | Supportive care (EAR, questionnaires, biospecimen collection) |
| Questionnaire AdministrationComplete questionnaires | Other | Supportive care (EAR, questionnaires, biospecimen collection) |
Primary outcome
The number of participants with gene expression of cellular senescence marker p16.
Time frame: Day 100 and 1 year post-transplant
This will be measured by mRNA/gene expression.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- 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.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
Kelly Rentscher, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphoid Cell Neoplasm, run by Medical College of Wisconsin at 1 site in United States.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical College of Wisconsin Cancer Center Clinical Trials Office (866-680-0505 ext. 8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants with gene expression of cellular senescence marker p16. (time frame: Day 100 and 1 year post-transplant). 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 5 Aug 2026.