Registry for Adults With Plasma Cell Disorders (PCD's)
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Blood Cancer, Lymphoma, Neurology, Endocrine, Hematology, Hematology, Hematology, Hematology |
| Therapuetic Areas: | Endocrinology, Hematology, Neurology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/26/2018 |
| Start Date: | February 9, 2018 |
| End Date: | February 2029 |
| Contact: | Amy Garrett, MA |
| Email: | amy_garrett@med.unc.edu |
| Phone: | 919-966-0895 |
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).
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).
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.
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.
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.
We found this trial at
1
site
101 Manning Drive
Chapel Hill, North Carolina 27514
Chapel Hill, North Carolina 27514
Principal Investigator: Sascha Tuchman, MD
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