CHAAMP (CHArlotte Advocate MGUS Project) Internal Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,665
- 试验地点
- 1
- 主要终点
- Number of Participants who were Enrolled
研究概览
简要总结
The purpose of this study is to identify multiple myeloma in the precancerous MGUS stage in order to reduce the risk of delayed diagnosis of multiple myeloma, decrease morbidity related to multiple myeloma at progression, and improve long term outcomes.
详细描述
The CHAAMP Internal Pilot is a pilot and feasibility study conducted to evaluate the feasibility of the trial methods before a full-scale screening effort is launched. High risk individuals 30 years of age or older residing in Charlotte or surrounding area will be screened for MGUS over one-year period with a target enrollment of 1665 participants. Individuals screening positive for monoclonal gammopathy will be provided a clinic referral for further diagnostic evaluation to confirm MGUS, SMM, or other PCD-related disorder, and will be given the opportunity to consent for the Longitudinal portion of the study. Participants diagnosed with MGUS and smoldering multiple myeloma will be prospectively followed for 10 years per protocol. Participants diagnosed with other plasma cell disorders will have their diagnosis and baseline data captured in the registry and followed for overall survival only.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •SCREENING Inclusion Criteria:
- •Age 30 years or older at the time of consent
- •Self-identify as Black and/or African American OR
- •First-degree relatives (parents, siblings, or children) of patients of any race or ethnicity diagnosed with a plasma cell disorder, including MGUS, smoldering multiple myeloma (SMM), multiple myeloma (MM), solitary plasmacytoma, plasma cell leukemia, AL amyloidosis, POEMS syndrome, and Waldenström's Macroglobulinemia
- •Capable and willing to provide informed consent. NOTE: HIPAA (Health Insurance Portability and Accountability Act) authorization for the release of personal health information may be included in the informed consent or obtained separately
- •Reside in Charlotte, NC, or the surrounding area, based on self-report
排除标准
- •Self-reported history of MGUS, SMM, MM, AL amyloidosis, plasma cell leukemia, solitary plasmacytoma, Waldenstrom Macroglobulinemia, and POEMS.
- •LONGITUDINAL Inclusion Criteria:
- •Test positive for monoclonal gammopathy during screening portion of the study
- •Consent to the longitudinal portion of the study
- •LONGITUDINAL Exclusion Criteria:
- •The participant previously underwent diagnostic work up as part of CHAAMP Internal Pilot that did not result in a diagnosis of MGUS, Smoldering Multiple Myeloma or other non-plasma cell disorder.
研究组 & 干预措施
MGUS and Smoldering Multiple Myeloma
Participants diagnosed with MGUS and smoldering multiple myeloma
干预措施: Blood draw for the laboratory assessment (Other)
Other Plasma Cell Disorders
Participants diagnosed with other plasma cell disorders
干预措施: Blood draw for the laboratory assessment (Other)
结局指标
主要结局
Number of Participants who were Enrolled
时间窗: Baseline, for an accrual period of one year
Determined for each potential participant approached to participate in this study (pre-screened), indicating whether or not the participant was enrolled (underwent blood draw to test for monoclonal gammopathy).
次要结局
- Monoclonal Gammopathy at Screening(From enrollment to availability of lab results, approximately 30 days)
- PCD Diagnosis at Screening(From enrollment to completion of diagnostic work up, approximately 90 days)
- PCD Diagnosis During Follow-Up(From enrollment to completion of follow up (10 years))
- CRAB Criteria at MM Diagnosis(From enrollment to completion of follow up (10 years))
- Time to MM Diagnosis(From enrollment to completion of follow up (10 years))
- Number of Participants who Interacted with a Community Champion(Baseline)
- Impact of Interaction with a Community Champion(Baseline)
- Number of MGUS Participants who Participate in Longitudinal Portion of Study(From enrollment to presentation of second (longitudinal) consent, approximately 90 days)
- Barriers to Screening Participation(Baseline)
- Barriers to Longitudinal Participation(From enrollment to presentation of second (longitudinal) consent, approximately 90 days)
- Psychological Counseling Referral(From enrollment to completion of diagnostic work up, approximately 90 days.)
- Light Chain MGUS Diagnosis at Screening(From enrollment to completion of diagnostic work up, approximately 90 days.)