NCT06391749

Clinical Validation of an MCED Test in Symptomatic Populations (K-ACCELERATE)

K-ACCELERATE: A Multi-center Prospective Trial to Evaluate Clinical Utility of Multi Cancer Early Detection Test as a Triage Test for Symptomatic Participants

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Gene Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the diagnostic performance of blood-based SPOT-MAS test in symptomatic individuals, the investigators sought to launch a prospective multicenter study, named K-ACCELERATE. The study aims to recruit 1,000 participants who develop symptoms and signs specific to the top five common cancer types including breast, colorectal, gastric, liver and lung cancer. Primary objective: Evaluate the performance of the SPOT-MAS test in detecting cancer in symptomatic populations. Secondary objectives: Evaluate the feasibility of incorporating SPOT-MAS as a triage test into primary care to increase the detection rates of malignant cancer while minimizing unnecessary referrals to invasive procedures.

Detailed description

Participants are recruited and referred to one of the five diagnosis pathways according to the participants' symptoms and signs listed. Before undertaking imaging tests, 10 ml of blood is collected in Streck tube for SPOT-MAS test. Participants undertake low-resolution imaging (LRI) tests matching with participants' referral diagnosis pathway. Imaging test results are returned within the same day. If participants get negative results from both SPOT-MAS and LRI, participants will receive treatment for the symptoms based on the standard treatment scheme at hospitals and be followed up for 12 months to confirm their cancer-free status. \- If participants get a positive result from either SPOT-MAS or LRI, participants will be referred to high-resolution imaging tests (HRI) or tissue biopsy to confirm the presence of tumor. For those with positive results confirming invasive tumors by HRI or tissue biopsy, patients will undergo treatment. The investigators do not provide financial support for their treatment. For those with no invasive lesions but having positive SPOT-MAS results, participants will be advised to re-take the SPOT-MAS test after 6 months. If the 2nd SPOT-MAS test results return positive, participants will be advised to perform whole body CT scan. If participants' scanning results return positive, participants will undergo tissue biopsy and treatment. If the 2nd SPOT-MAS or whole body CT scan is negative, participants will be followed-up for an additional 6 months by surveying to confirm the cancer-free status. The enrolment is anticipated to last for approximately 6 months

Conditions

• Cancer Colon
• Cancer, Liver
• Cancer, Lung
• Cancer, Breast
• Cancer, Gastric

Timeline

• Start date: 2024-07-30
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-04-30
• Last updated: 2025-07-16

Locations

1 site across 1 country: Vietnam