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

Cancer, Breast Clinical Trial

Official title: 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 Recruiting

Clinical Trial Summary

To evaluate the diagnostic performance of blood-based SPOT-MAS test in symptomatic individuals, we 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.

Clinical Trial Description

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

Related Conditions & MeSH terms

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

• NCT number: NCT06391749
• Study type: Observational
• Source: Gene Solutions
• Contact: Le Son Tran, Ph.D
• Phone: +84705196257
• Email: sontran@genesolutions.vn
• Status: Recruiting
• Start date: April 2024
• Completion date: October 2025