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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05556928
Other study ID # IRB-300005372
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 21, 2020
Est. completion date December 31, 2024

Study information

Verified date February 2024
Source University of Alabama at Birmingham
Contact Smith Giri, Dr.
Phone (205) 638-2120
Email CAREheme@peds.uab.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

All participants will be invited to participate in a patient reported geriatric assessment questionnaire as well as an objective physical function testing. This includes the Short Physical Performance Battery (SPPB) that evaluates lower extremity performance and muscle strength assessment via hand grip dynamometer. Participants will also complete a 12 item modified version of PRO-CTCAE. This will be administered by trained research staff at the time of study enrollment. Repeat CARE instruments (Follow-up GA questionnaire and Physical Function test) will be administered after the baseline visit to measure changes in patient reported outcomes at 3 months, 6 months, and one year. A one-time blood or saliva sample will be requested and obtained at baseline or a follow-up visit.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Individuals who are <50 years old. - Patients who do not read and/or speak English will not be eligible for this study as many of the questionnaires are not validated in other languages. No exclusions will be made based on gender, ethnicity or race.

Study Design


Locations

Country Name City State
United States Kirklin Clinic of UAB Hospital Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 To administer a patient reported geriatric assessment and a brief objective physical assessment. To measure the proportion of patients with overall and domain-specific geriatric impairments, the proportion of patients with Myopenia, and the proportion of patients with frailty. 5 years
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