MyeloGen: Germline Testing for Predisposition to Myeloid Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 200
- 主要终点
- Incidence Rate of Positive Genetic Results
研究概览
简要总结
This research study is evaluating the feasibility of conducting cancer genetic testing using healthy skin cells among participants with a diagnosis of a blood cancer. Additionally, investigators will evaluate how often participants with blood cancers are found to have risk for cancer based on family genes.
详细描述
The purpose of this prospective, non-randomized, non-therapeutic, single arm study is to determine the feasibility and benefit of performing genetic testing for all participants with a blood cancer diagnosis regardless of clinical suspicion.
Research study procedures include screening for eligibility, in-clinic visits, questionnaires, and skin punch biopsies. Participants will receive germline genetic testing with a comprehensive hereditary cancer gene panel.
It is expected that about 200 individuals with blood cancer will take part in this research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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 or Spanish.
排除标准
- •Patients with who cannot safely undergo skin biopsy as adjudicated by the study team.
- •Patients who have previously undergone germline genetic testing for predisposition to myeloid malignancies
研究组 & 干预措施
Germline Genetic Testing
Participants will be enrolled and will complete study procedures as follows:
- Baseline visit with educational video and questionnaires.
- Skin punch biopsy.
- Genetic testing results.
- Surveys and questionnaires.
- Follow up via medical records for up to 2 years from time of study consent.
干预措施: Genetic Blood Test (Other)
结局指标
主要结局
Incidence Rate of Positive Genetic Results
时间窗: Up to 63 months
Defined as the proportion of participants with a "positive" result on the germline genetic testing. Positive results equal Variants classified as Pathogenic (P), Likely pathogenic (LP), or Variants of Uncertain Significance (VUS) with supporting pathogenic criteria.
Genetic Testing Completion Rate
时间窗: Up to 63 months
Feasibility is defined as a minimum of 75% of consented participants complete germline genetic testing with the return of test results within 10 weeks of study consent.
次要结局
- Participant Satisfaction Score on GTS Survey 2(Up to 130 days from baseline)
- Multidimensional Impact of Cancer Risk Assessment (MICRA) Score(Up to 130 days from baseline)
- Detection Rate of Germline Predisposition(Up to 63 months)
- Impact of Genetic Results on Clinical Decision-Making(Up to 130 days from baseline)
- Participant Knowledge of Genetic Testing Post-Education(At baseline, following pre-educational video)
- Participant Satisfaction Score on Genetic Testing Satisfaction (GTS) Survey 1(At baseline)
- Participant Knowledge of Genetic Testing Pre-Education(At baseline)
- Participant Decisional Regret Score(Up to 130 days from baseline)
研究者
Christopher Reilly
Principle Investigator
Dana-Farber Cancer Institute