CHAAMP (CHArlotte Advocate MGUS Project) Internal Pilot Study
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Blood draw for the laboratory assessment.
- Кому может быть актуально
- Состояния в реестре: Multiple Myeloma, Multiple Myeloma Progression, Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM). Базовые параметры: от 30 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Другое Blood draw for the laboratory assessment
Screening blood sample collection to test for MGUS
Первичные конечные точки
- Number of Participants who were Enrolled [Срок оценки: Baseline, for an accrual period of one year]
Вторичные конечные точки (12)
- Monoclonal Gammopathy at Screening [Срок оценки: From enrollment to availability of lab results, approximately 30 days]
- PCD Diagnosis at Screening [Срок оценки: From enrollment to completion of diagnostic work up, approximately 90 days]
- PCD Diagnosis During Follow-Up [Срок оценки: From enrollment to completion of follow up (10 years)]
- CRAB Criteria at MM Diagnosis [Срок оценки: From enrollment to completion of follow up (10 years)]
- Time to MM Diagnosis [Срок оценки: From enrollment to completion of follow up (10 years)]
- Number of Participants who Interacted with a Community Champion [Срок оценки: Baseline]
- Impact of Interaction with a Community Champion [Срок оценки: Baseline]
- Number of MGUS Participants who Participate in Longitudinal Portion of Study [Срок оценки: From enrollment to presentation of second (longitudinal) consent, approximately 90 days]
- Barriers to Screening Participation [Срок оценки: Baseline]
- Barriers to Longitudinal Participation [Срок оценки: From enrollment to presentation of second (longitudinal) consent, approximately 90 days]
- Psychological Counseling Referral [Срок оценки: From enrollment to completion of diagnostic work up, approximately 90 days.]
- Light Chain MGUS Diagnosis at Screening [Срок оценки: From enrollment to completion of diagnostic work up, approximately 90 days.]
Критерии участия
SCREENING Inclusion Criteria:
- Age 30 years or older at the time of consent
- Either:
- 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
SCREENING Exclusion Criteria:
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- Atrium Health Levine Cancer — Charlotte
Идентификаторы
NCT: NCT06644625 · IRB00107462 · LCI-PCD-MGUS-SCRN-001 · NCI-2025-00147