NCT03717844

Registry for Adults With Plasma Cell Disorders (PCD's)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The primary purpose of this protocol is to create a registry of patients with plasma cell disorders (PCDs), including for example the cancer multiple myeloma (MM), who complete the assessment, previously known as a "geriatric assessment," as is outlined in this protocol. Secondary objectives include measuring the response rate to participation of patients in this study, assessing patient satisfaction with the questionnaire, and gathering information that would lend support for future research into these types of assessments in patients with PCDs. Additionally the study offers an optional blood draw to look at a genetic marker of aging called p16INK4a (IRB 15-1899, IRB 15-0244).

Detailed description

OBJECTIVES: Primary 1. To create a Registry (to be called the PCD Registry) of PCD patients 2. To have participating patients complete an assessment at enrollment and to repeat the assessment longitudinally over time. Secondary 1. To gather information, including patterns of patient care, that would lend support for future research in the PCD population. Specific research questions would be explored within separate IRB-reviewed protocols. 2. To bank blood samples for future research involving adults with PCD's, specifically examining p16INK4a and other markers to be specified in future, separate, IRB-approved protocols as specific research questions are identified. OUTLINE: Patients complete an assessment at baseline and then longitudinally over time which involves a multi-dimensional inter-disciplinary evaluation of a patient's functional status (ability to live independently at home and in the community), co-morbid medical conditions, cognition, psychological status, social functioning and support, medication review, and nutritional status. Patients' medical records are also reviewed.

Conditions

• Multiple Myeloma
• Amyloidosis
• Cryoglobulinemia
• Castleman's Disease
• Light Chain Deposition Disease
• Heavy Chain Deposition Disease
• Polyneuropathy Organomegaly Endocrinopathy Monoclonal Gammopathy and Skin Changes
• Smoldering Multiple Myeloma
• Plasma Cell Leukemia

Timeline

• Start date: 2018-02-09
• Primary completion: 2028-02-01
• Completion: 2029-02-01
• First posted: 2018-10-24
• Last updated: 2025-11-20

Locations

1 site across 1 country: United States