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 : November 20, 2020
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|