The PATHFINDER 2 Study: Evaluating the Safety and Performance of the GRAIL Multi-Cancer Early Detection Test in an Eligible Screening Population
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- GRAIL, Inc.
- 入组人数
- 35,883
- 试验地点
- 94
- 主要终点
- Test performance: diagnosis of invasive cancer, assessed by negative predictive value (NPV).
研究概览
简要总结
This is a prospective, multi-center interventional study of the GRAIL multi-cancer early detection (MCED) test with return of test results for participants enrolled through healthcare systems in North America. The purpose of this study is to evaluate the safety and performance of the GRAIL MCED test in a population of individuals who are eligible for guideline-recommended cancer screening. In cases with a "cancer signal detected" test result, participants will undergo diagnostic procedures based on the test returned cancer signal origin(s) to determine if they have cancer. The number and types of diagnostic procedures required to achieve diagnostic resolution will be assessed. Participant-reported outcomes will be collected at several time points to assess participants' perceptions about the multi-cancer early detection test.
The study will enroll approximately 35,000 and no more than 38,500 participants as defined by eligibility criteria over an anticipated enrollment period of approximately 36 months at up to 40 clinical institutions within North America. Participants will be actively followed for approximately 3 years from the date of their enrollment.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be at least 50 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).
- •Participants must be capable of giving signed and legally effective informed consent
排除标准
- •Undergoing or referred for diagnostic evaluation due to clinical suspicion for cancer (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the basis of a suspicious imaging abnormality).
- •Personal history of invasive solid tumor or hematologic malignancy, diagnosed within the 3 years prior to expected enrollment date, or diagnosed greater than 3 years prior to expected enrollment date and never treated.
- •Individuals with a diagnosis of non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin are not excluded.
- •Prior/Concurrent Concomitant Therapy (Medications/Treatments):
- •Definitive treatment for invasive solid tumor or hematologic malignancy within the 3 years prior to expected enrollment date. Adjuvant hormone therapy for cancer (e.g. for breast or prostate cancer) is not an exclusion criterion.
- •Individuals who will not be able to comply with the protocol procedures.
- •Individuals who are not currently registered patients at a participating center.
- •Previous or current participation in another GRAIL-sponsored study. "Participation" is defined as having signed consent and provided a blood sample.
- •Previous or current employees or contractors of GRAIL.
- •Current pregnancy (by self-report of pregnancy status)
研究组 & 干预措施
Participants 50 years of age or older
The study will aim to enroll a diverse participant population generally representative of the US population with respect to race, ethnicity, and sex. The target age categories of 60-69 years and 70-79 years will be enriched to increase the number of cancer events that are observed during the study.
干预措施: Multi-Cancer Early Detection Test (Device)
结局指标
主要结局
Test performance: diagnosis of invasive cancer, assessed by negative predictive value (NPV).
时间窗: Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by specificity.
时间窗: Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by cancer signal origin (CSO) accuracy.
时间窗: Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by number needed to screen to detect an invasive cancer (NNS).
时间窗: Up to 3 Years
Safety: Number and type of invasive procedures performed in participants with a cancer signal detected by the multi-cancer early detection (MCED) test and no cancer diagnosis at the time of diagnostic resolution (i.e., false positive test result).
时间窗: Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by positive predictive value (PPV).
时间窗: Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by sensitivity.
时间窗: Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by observed cancer detection rate (CDR).
时间窗: Up to 3 Years
次要结局
- Participant-reported anxiety resulting from use of the multi-cancer early detection (MCED) test assessed via questionnaire at various time points during the study.(Up to 3 Years)
- Cancer detection rate of confirmatory PET-CT in participants for whom cancer signal origin directed workups do not result in diagnosis of cancer.(Up to 3 Years)
- Accuracy of initial multi-cancer early detection (MCED) test result and cancer signal origin prediction, among the subset of participants with a research blood draw.(Up to 3 Years)
- Participant-reported intention to follow and use guideline recommended cancer screening procedures after use of the multi-cancer early detection (MCED) test assessed via questionnaire at various time points during the study.(Up to 3 Years)
- Number and type of diagnostic evaluations (imaging procedures, invasive procedures, laboratory test) by predicted cancer signal origin and outcome of diagnostic resolution.(Up to 3 Years)
- Per-participant radiation exposure during diagnostic evaluation for test positive participants.(Up to 3 Years)
- Participants-reported perceptions about the multi-cancer early detection (MCED) test including satisfaction with the MCED tests and attitudes towards subsequent MCED testing assessed via questionnaire at various time points during the study.(Up to 3 Years)