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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
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief 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).

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

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
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





Primary Outcome Measures :
  1. Creation of a Registry of Plasma Cell Disorder (PCD) patients [ Time Frame: 10 years ]
  2. Completion of baseline and longitudinal assessments in PCD patients [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. 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.

  2. 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
Blood samples will be banked for future research involving adults with PCDs, specifically examining p16INK4a and other markers to be specified in future, separate, IRB-reviewed protocols as specific research questions are identified.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Amy Garrett, MA 919-966-0895 amy_garrett@med.unc.edu
Contact: Kirsten Nyrop, PhD 919-962-5139 kirsten_nyrop@med.unc.edu

Locations
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United States, North Carolina
North Carolina Cancer Hospital Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Sascha Tuchman, MD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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Principal Investigator: Sascha Tuchman, MD UNC Lineberger Comprehensive Cancer Center

Additional Information:

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03717844     History of Changes
Other Study ID Numbers: LCCC 1728
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
Leukemia, Plasma Cell
Polyneuropathies
POEMS Syndrome
Cryoglobulinemia
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Castleman Disease
Amyloidosis
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Proteostasis Deficiencies
Metabolic Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Hypergammaglobulinemia
Precancerous Conditions
Lymphatic Diseases