MyeloGen: Germline Testing for Predisposition to Myeloid Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Successful Completion Rate
研究概览
简要总结
The goal of this research study is to evaluate the feasibility of germline genetic testing using the investigational MyeloGen Gene Panel in adult participants diagnosed with myeloid malignancies.
详细描述
This prospective, single arm study aims to evaluate the feasibility of germline genetic testing using the investigational MyeloGen Gene Panel in adult participants diagnosed with myeloid malignancies. Investigators hope to learn how to best incorporate routine genetic testing in clinical care for participants with blood cancers, regardless of personal or family history of blood cancer.
The research study procedures include screening for eligibility, in-clinic visits, questionnaires, and punch skin biopsies.
It is expected that about 200 people will take part in this research study.
The laboratory sponsor of this protocol is Broad Clinical Laboratory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •Age of 18 years or older
- •Participants must have histologically confirmed myeloid malignancy OR bone marrow failure within the last 6 months prior to screening.
- •Ability to understand and provide a signed and completed consent document in English.
排除标准
- •Participants who cannot safely undergo clinically indicated skin biopsy as adjudicated by the study team.
- •Participants who have previously undergone germline genetic testing for predisposition to myeloid malignancies
研究组 & 干预措施
MyeloGen Germline Testing Group
Enrolled participants will complete:
- Baseline visit with questionnaires, educational video, and punch skin biopsy
- Negative genetic test results notification via mail
- Positive genetic results will be followed up by an appointment with a genetic counselor or physician
- Post-results questionnaires
- Follow up via medical records for up to 2 years from time of study consent.
干预措施: MyeloGen Gene Panel (Device)
结局指标
主要结局
Successful Completion Rate
时间窗: Up to 10 weeks
Successful completion rate of germline genetic testing will be defined as the proportion of participants who return genetic test results within 10 weeks of study consent, which would require there be no excessive delays in obtaining a skin biopsy.
次要结局
- Number of Participants with Positive Results(Up to 12 weeks)
- Patient Reported Outcome of Germline Genetic Testing based on GST Survey(Up to 60 days)
- Number of Participants with an Identified Germline Predisposition on Generic Testing Who Haven't Met NCNN Guideline-based Germline Genetic Testing Recommendations(Up to 12 weeks)
研究者
Christopher Reilly
Sponsor-Investigator
Dana-Farber Cancer Institute