NCT07400393尚未招募不适用
Healey ALS MyMatch Common Screening Protocol (MCSP) for Determining Preliminary Eligibility for ALS MyMatch Early Phase Clinical Trials
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- Preliminary eligibility to be matched to a MyMatch Trial
研究概览
简要总结
The goal of the Healey ALS MyMatch Common Screening Protocol (MCSP), an observational study, is to identify individuals with ALS who may be eligible to be matched to a currently enrolling ALS MyMatch trial. Participants will complete a MCSP Screening Visit and undergo clinical assessments, laboratory testing, and biomarker analyses to determine preliminary trial eligibility. The study also characterizes clinical, genetic, and biofluid biomarker profiles, assesses the prevalence of ALS-associated gene variants, and banks blood samples for future ALS and biomarker research. MCSP enables simultaneous screening for multiple trial-specific biomarkers and uses a targeted medical history form to optimize matching of participants to appropriate MyMatch trials.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent.
- •Adults > 18 years of age.
- •Diagnosis of symptomatic ALS that meets either the revised El Escorial Criteria.(clinically possible, probable, probable lab-supported, or definite) or the Gold Coast Criteria.
- •Available or pending clinically obtained CLIA ALS genetic panel report.
- •Time since onset of weakness due to ALS ≤ 24 months at the time of MCSP screening.
- •Slow VC ≥ 65% of predicted capacity value for gender, height and age at screening.
- •Clinically unremarkable Complete Blood Counts as per SI's discretion, including but not limited to Hemoglobin ≥ 9 g/dL.
- •Ability and willingness to complete all study procedures per SI's assessment.
- •Negative pregnancy test at screening for women of child-bearing potential (WOCB), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months).
排除标准
- •Clinically significant unstable medical or surgical condition that would pose a risk to the participant's trial procedural participation or interfere with data collection, per SI's assessment.
- •Presence of cognitive or mental health disorders impairing ability to provide informed consent for the study per SI assessment.
- •Active cancer or history of cancer, unless it was successfully treated for durable remission or cure more than 3 years ago. (Note that basal cell carcinoma, squamous cell carcinoma in situ, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies that have been curatively excised at any time previously and with no evidence of disease recurrence for at least 3 years are not exclusionary.)
- •Prior solid organ transplantation.
- •Use of investigational treatments for ALS (off-label use or active participation in a clinical trial) within 5 half-lives (if known) or 30 days (whichever is longer) prior to the MCSP Screening Visit. (Please refer to the Manual of Procedures (MOP) for current list of experimental therapies)
- •Screening 12-lead ECG showing QT interval corrected for rate (QTcF) > 470 msec for women and > 450 msec for men, absence of second degree or higher AV block or other clinically significant cardiac arrythmias.
- •Clinically significant abnormalities in the Comprehensive Metabolic Panel per SI's assessment, including but not limited to:
- •Serum alanine aminotransferase or aspartate aminotransferase > 3 times the upper limit of normal, or serum bilirubin > 1.5 × upper limit of normal
- •Estimated GFR (eGFR) of < 30 mL/min/1.73m2
- •Other clinically significant electrolyte and metabolic abnormalities
- •If female, breastfeeding, pregnant, or of child-bearing potential and unwilling to use effective contraception for duration of the trial and after discontinuing treatment as outlined in the ALS MyMatch trial protocol.
- •Clinically significant unstable medical conditions (other than ALS) that would pose a risk to the participant, per SI's assessment (e.g., cardiovascular instability, systemic infection,), or clinically significant laboratory abnormality or ECG changes.
- •Exposure at any time to any gene therapies under investigation for the treatment of ALS (off-label use or investigational).
- •Participants who require Permanent assisted ventilation (PAV). PAV defined as more than 22 hours per day of noninvasive or invasive mechanical ventilation for more than seven consecutive days. The date of onset of PAV is the first day of the seven days.
结局指标
主要结局
Preliminary eligibility to be matched to a MyMatch Trial
时间窗: From enrollment to the end of the 45-day MCSP screening period or at the end of completing a baseline visit for a MyMatch trial.
To determine preliminary eligibility of early ALS (\< 24 months from weakness onset) participants for actively enrolling ALS MyMatch trial(s)
次要结局
- Repository for future research(From enrollment to the end of the 45-day MCSP screening period or at the end of completing a baseline visit for a MyMatch trial. Samples will be banked indefinitely for future research on ALS and related diseases.)
- Prevalence of gene mutations(From enrollment to the end of the 45-day MCSP screening period or at the end of completing a baseline visit for a MyMatch trial. Samples will be banked indefinitely for future research on ALS and related diseases.)
- Collect and bank samples(From enrollment to the end of the 45-day MCSP screening period or at the end of completing a baseline visit for a MyMatch trial. Samples will be banked indefinitely for future research on ALS and related diseases.)
研究者
Suma Babu
Associate Professor of Neurology at Harvard Medical School and Co-Director of the Neurological Clinical Research Institute (NCRI)
Massachusetts General Hospital
相似试验
尚未招募
不适用
Screening for MASLD-related Advanced Fibrosis in Type 2 DiabetesNCT07270822Hospices Civils de Lyon1,714
尚未招募
不适用
Long-term Health Outcomes of Screen Detected and Potential Celiac Disease PatientsCeliac DiseaseNCT07366151Tampere University Hospital250
尚未招募
不适用
Clinical Trial of Digital Therapeutics (One.Dr) for Suspected Orthostatic Hypotension PatientsHypotensionNCT07348445Yonsei University86
尚未招募
不适用
Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AINCT07305324Yale University40
招募中
2 期
LAMSA2020: “A phase II randomized study to assess the efficacy on outcome of Venetoclax combined with Cytarabine versus Idarubicin combined with Cytarabine administered as post-remission therapy to elderly patients with acute myeloid leukemia in first remission”2022-502392-37-00French Innovative Leukemia Organization114