RECRUITING

Registry for Adults With Plasma Cell Disorders (PCD's)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Registry for Adults With Plasma Cell Disorders (PCD's)

Quick Facts

Study Start:2018-02-09
Study Completion:2029-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03717844

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * Age ≥18 years.
  4. * Must consent to participation in this study and agree to complete the assessment at baseline and follow-up time points.
  5. * Must be able to read and speak English.
  1. * Physical or psychiatric/behavioral illnesses or problems that the treating clinician feels would preclude successful participation in the study.
  2. * There are no imaging or lab studies required to determine eligibility.

Contacts and Locations

Study Contact

Nicholas Mangieri
CONTACT
(919) 966-4432
nicholas_mangieri@med.unc.edu
Kendall Conder
CONTACT
(919) 966-4432
kendall_conder@med.unc.edu

Principal Investigator

Sascha Tuchman, MD
PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center

Study Locations (Sites)

North Carolina Cancer Hospital
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • Sascha Tuchman, MD, PRINCIPAL_INVESTIGATOR, UNC Lineberger Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-02-09
Study Completion Date2029-02

Study Record Updates

Study Start Date2018-02-09
Study Completion Date2029-02

Terms related to this study

Additional Relevant MeSH Terms

  • 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