NCT05556928

Brief Summary

The primary purpose of this protocol is to create a registry of older (≥50 years old) patients with Hematologic Malignancies. Our main objectives include: To understand the prevalence of frailty and geriatric impairments among patients aged ≥50y and above diagnosed with a hematologic malignancy at UAB and to gather information that would lend support for future research in this vulnerable population.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Jul 2020Dec 2027

Study Start

First participant enrolled

July 21, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

7.4 years

First QC Date

September 22, 2022

Last Update Submit

December 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Create the CARE-Heme Registry

    To establish and maintain a well-annotated registry (to be called the 'CARE-Heme' Registry) of adults ≥50 years of age with a hematologic malignancy to improve our understanding of this vulnerable population.

    5 years

Secondary Outcomes (1)

  • To administer a patient reported geriatric assessment and a brief objective physical assessment.

    5 years

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients ≥50 years of age with a diagnosis of any Hematologic Malignancy having an appointment at any participating UAB entity.

You may qualify if:

  • Patients are ≥50 years of age.
  • Patients have a biopsy proven diagnosis of Hematologic Malignancy (Multiple Myeloma, AL Amyloidosis, Waldenstrom's Macrogloblunemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Myelodysplastic syndromes, Myeloproliferative Neoplasm, Acute/Chronic Myeloid Leukemia, Acute/Chronic Lymphoid Leukemia).
  • Patients have appointments at UAB including if they are an inpatient or other clinic locations.

You may not qualify if:

  • Individuals who are \<50 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirklin Clinic of UAB Hospital

Birmingham, Alabama, 35294, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The purpose of the biospecimen collection is to support future investigations aimed at looking at biomarkers of frailty and aging and other new-onset comorbidities.

MeSH Terms

Conditions

Multiple MyelomaAmyloidosisLeukemia, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesLeukemia

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2022

First Posted

September 27, 2022

Study Start

July 21, 2020

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

December 8, 2025

Record last verified: 2025-12

Locations