NCT06391749Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 16 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 25 Apr 2024
- Start date
- 30 Jul 2024
- Primary completion date
- Jul 2026
- Lead sponsor
- Gene Solutions
- Diseases
- Lung cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer
- NCT number
- NCT06391749
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 30 Jul 2024 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Having a history of invasive cancer diagnosed within the last 5 years
- Having undergone treatment for invasive cancer within the last 5 years
- Having a history of bone marrow transplant or whole blood transfusion within the last 3 months
Other
- Being pregnant
Who the study is looking for
- Male or Female, aged 18 years or above Participants are willing and able to give informed consent for participation in the study
- Participants aged over 18 years
- Individuals presenting symptoms associated witht breast, colorectal, gastric, liver and lung cancer (see below) and being referred for low resolution imaging tests including US breast, chest x-ray, colorectal endoscopy, gastroscopy, US abdomen or relevant diagnostic modalities.
- Symptoms and Signs
- Breast symptoms: Axillary lump/mass; Breast lump/mass; Breast pain; Nipple discharges; Breast skin change
- Lung symptoms: Symptoms for more than 3 weeks: Dyspnea (shortness of breath); Chest pain; Cough that does not go away; Hemoptysis (coughing up blood)
- Colorectal symptoms: Hematochezia (blood in the stool); Diarrhea ≥ 3 weeks; Constipation ≥ 3 weeks; Abdominal pain ≥ 3 weeks
- Gastric symptoms: Epigastric pain ≥ 3 weeks; Hematemesis (vomiting blood)
- Liver symptoms: Jaundice (yellowing of the skin and eyes); Right upper quadrant (RUQ) pain; Significant weight loss (≥10% of body weight in previous 6 months)
- Consent to undertake high resolution imaging tests or biopsy upon receiving positive test results from either SPOT-MAS or low-resolution imaging tests
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Genetics Institute Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.