Registry for Adults With Plasma Cell Disorders (PCD's)
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|ClinicalTrials.gov Identifier: NCT03717844|
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
|Condition or disease|
|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|
- 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.
- 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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2000 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||Registry for Adults With Plasma Cell Disorders (PCD's)|
|Actual Study Start Date :||February 9, 2018|
|Estimated Primary Completion Date :||February 2028|
|Estimated Study Completion Date :||February 2029|
- Creation of a Registry of Plasma Cell Disorder (PCD) patients [ Time Frame: 10 years ]
- Completion of baseline and longitudinal assessments in PCD patients [ Time Frame: 10 years ]
- Creation of information that would lend support for future PCD research [ Time Frame: 10 years ]Including patterns of patient care that would lend support for future research in patients with confirmed PCD's.
- Response rates of assessment in PCD patients and their satisfaction with the assessment [ Time Frame: 10 years ]
Done by measuring:
- percentage of patients contacted who consent to complete the assessment percentage of patients able to complete the self-administered portion of the assessment without assistance
- the length of time necessary to complete the assessment
- the variance and number of missing items
- the percentage of geriatric assessments that contain all three of the following items: Timed Up and Go Assessment, Blessed Orientation-Memor Concentration Test, and the healthcare professional-rated Karnofsky performance status.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717844
|Contact: Amy Garrett, MAfirstname.lastname@example.org|
|Contact: Kirsten Nyrop, PhDemail@example.com|
|United States, North Carolina|
|North Carolina Cancer Hospital||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator: Sascha Tuchman, MD|
|Principal Investigator:||Sascha Tuchman, MD||UNC Lineberger Comprehensive Cancer Center|