正在进行的大规模临床试验 chatGPT
GRAIL is actively conducting several large-scale clinical trials to evaluate the Galleri® multi-cancer early detection (MCED) blood test, which aims to identify over 50 types of cancer through a single blood draw. Here are the key ongoing studies:
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Major Ongoing Clinical Trials for Galleri
1. PATHFINDER 2 (U.S.)
Objective: Assess the safety and performance of Galleri in individuals aged 50 and older who are eligible for guideline-recommended cancer screenings.
Enrollment: Over 35,000 participants across more than 30 healthcare institutions in North America.
Timeline: Enrollment began in December 2021; results from the first 25,000 participants are expected in the second half of 2025.
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2. NHS-Galleri Trial (U.K.)
Objective: Evaluate Galleri's effectiveness in reducing late-stage cancer diagnoses when used alongside standard National Health Service (NHS) screenings.
Enrollment: Over 140,000 participants aged 50 to 77.
Timeline: Final study visits completed; results anticipated in 2026.
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3. REACH (Galleri-Medicare Study, U.S.)
Objective: Assess the real-world clinical impact of Galleri among Medicare beneficiaries, focusing on reducing stage IV cancer diagnoses and evaluating healthcare resource utilization.
Enrollment: Up to 50,000 Medicare beneficiaries, with an emphasis on including historically underrepresented populations.
Timeline: First participant enrolled in July 2024; study is ongoing.
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4. REFLECTION Study (U.S. Veterans Affairs)
Objective: Understand the real-world experience of Galleri in routine clinical settings among U.S. veterans, including those with toxic exposures.
Findings: Initial results indicate cancer signal detection rates consistent with other populations tested with Galleri.
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5. SUMMIT Study (U.K.)
Objective: Validate Galleri's performance, particularly in individuals at high risk for lung cancer.
Enrollment: Approximately 130,000 participants aged 55 to 77.
Timeline: Study commenced in April 2019 and is expected to conclude in August 2030.
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These studies are integral to GRAIL's efforts to obtain FDA approval for Galleri and to integrate the test into broader cancer screening programs. The Galleri test is currently available in the U.S. by prescription but has not yet received FDA approval.
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Health
If you're interested in participating in a clinical trial or learning more about Galleri, you can visit GRAIL's official website or consult with your healthcare provider for more information.
Major Ongoing Clinical Trials for Galleri
