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临床试验/NCT07620535
NCT07620535尚未招募不适用

Decision Counseling and Follow-up (DCaF) for Shield+ Patients

Guardant Health, Inc.1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
350
试验地点
1

研究概览

简要总结

Prospective, observational, minimal-risk study evaluating decision-making, decisional conflict, intention to undergo complete diagnostic evaluation (CDE), and colonoscopy completion after a positive Shield TM blood-based colorectal cancer screening test result.

详细描述

The DCaF study uses a prospective, observational design to characterize how patients make decisions following a Shield(+) screening result and to assess real-world adherence to recommended diagnostic colonoscopy. Because the intervention of interest is the patient's naturally occurring decision-making process-not the performance of the test itself-a non-interventional design is methodologically appropriate and minimizes participant burden. Incorporating decision counseling allows systematic evaluation of changes in preference, decisional conflict, and intention, while linkage to real-world evidence (RWE) claims data provides an efficient and objective method for determining colonoscopy completion. This approach enables the study to identify behavioral, clinical, and system-level factors associated with follow-up adherence without altering standard clinical care.

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
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant is 45-75 years old at the time of ShieldTM test order.
  • Participant has a valid Shield(+) test result.
  • Participant is willing and able to complete the informed consent process
  • Participant is able to complete the informed consent process and decision counseling session in English

排除标准

  • Participant is already enrolled in another Guardant Health, Inc. clinical study or has received a positive MCD result for a cancer type other than CRC.

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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