ClinicalTrials.gov record NCT03717844
Registry for Adults With Plasma Cell Disorders (PCD's)
Registry for Adults With Plasma Cell Disorders (PCD's)
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This study creates a registry of adults (age ≥18) who have a documented plasma cell disorder. Participants complete a baseline multidimensional assessment (function, cognition, medications, nutrition, social support, etc.) and repeat it over time; medical records are also reviewed. The study offers an optional blood draw to bank samples for p16INK4a and future research. The protocol will also measure how well patients respond to and are satisfied with the assessment.
What it is studying. The study is building a registry to collect repeated, standardized assessments from people with plasma cell disorders and to bank optional blood samples for future research. It will track patterns of care and measure response and satisfaction with the assessment process. Stored blood will be used to look at the aging marker p16INK4a and potentially other markers in later, separate protocols.
What the researchers hope to learn. Create a registry of patients with plasma cell disorders; collect longitudinal multidimensional assessments; document patterns of care to support future research; bank blood samples to study p16INK4a and other markers; measure assessment completion rates and participant satisfaction.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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).
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Patients have an outpatient appointment or are hospitalized inpatient at UNC Cancer Hospitals, or affiliated clinic settings or participating sites for the evaluation and management of a PCD.
- Patients have a documented diagnosis of PCD defined as the presence of a monoclonal protein and/or monoclonal plasma cell population. Examples of PCDs include but are not limited to monoclonal gammopathy of uncertain significance; smoldering myeloma; multiple (active) myeloma; plasma cell leukemia; Castleman's disease; amyloidosis; light and/or heavy chain deposition disease; Polyneuropathy, Organomegaly, Endocrinopathy,Monoclonal gammopathy and Skin changes (POEMS) syndrome; and cryoglobulinemia.
- Age ≥18 years.
- Must consent to participation in this study and agree to complete the assessment at baseline and follow-up time points.
- Must be able to read and speak English.
Exclusion criteria
- Physical or psychiatric/behavioral illnesses or problems that the treating clinician feels would preclude successful participation in the study.
- There are no imaging or lab studies required to determine eligibility.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
OBJECTIVES: Primary
- To create a Registry (to be called the PCD Registry) of PCD patients
- To have participating patients complete an assessment at enrollment and to repeat the assessment longitudinally over time.
Secondary
- 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.
- 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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants complete a multi-part assessment at enrollment and at repeated time points over follow-up. The assessment covers ability to function independently, other medical conditions, thinking/memory, mood and social support, medication review, and nutrition; it may include short tests such as the Timed Up and Go, a brief cognition test, and a clinician-rated performance score. Study staff will review participants' medical records. There is an optional blood draw to bank samples for research, including testing the aging marker p16INK4a.
How the study is structured. An observational, prospective registry (cohort) in which participants complete a baseline assessment and repeated follow-ups over time, have their medical records reviewed, and may give an optional blood sample for banking. The registry is planned to follow participants for up to 10 years.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Castleman disease
Important dates
- Study start
- Feb 9, 2018
- Primary completion
- February 2028 (estimated)
- Study completion
- February 2029 (estimated)
- Target enrollment
- 2000 participants (estimated)
- Last updated on registry
- Nov 20, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Nicholas Mangieri 📞 (919) 966-4432 ✉ nicholas_mangieri@med.unc.edu
- Kendall Conder 📞 (919) 966-4432 ✉ kendall_conder@med.unc.edu
Participating sites (1)
- North Carolina Cancer HospitalRecruiting
Chapel Hill, North Carolina, 27599 · United States
- Sascha Tuchman, MD
Terms used on this page · explanations by MedicalUpdates.ai
- primary purpose
- The main reason an interventional study is being done, for example treatment, prevention, diagnosis, supportive care or basic science.
- registry
- An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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