Evaluating a blood test for early cancer detection in symptomatic patients
K-ACCELERATE: A Multi-center Prospective Trial to Evaluate Clinical Utility of Multi Cancer Early Detection Test as a Triage Test for Symptomatic Participants
This study is testing a new blood test called SPOT-MAS to see if it can help find common cancers earlier in people who have symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gene Solutions Industry-sponsored |
| Locations | 1 site (Ho Chi Minh City) |
| Trial ID | NCT06391749 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the diagnostic performance of the SPOT-MAS blood test in individuals showing symptoms of common cancers, including breast, colorectal, gastric, liver, and lung cancer. It will recruit 1,000 participants who will undergo blood collection and low-resolution imaging tests based on their symptoms. If either the SPOT-MAS test or imaging indicates potential cancer, participants will be referred for further high-resolution imaging or biopsy. The study also seeks to determine the feasibility of using the SPOT-MAS test as a triage tool in primary care settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who present symptoms associated with breast, colorectal, gastric, liver, or lung cancer.
Not a fit: Patients without symptoms indicative of the specified cancers or those who are not willing to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of cancers, improving treatment outcomes for patients.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for early cancer detection, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Being pregnant
Where this trial is running
Ho Chi Minh City
- Medical Genetics Institute — Ho Chi Minh City, Vietnam (Recruiting)
Study contacts
- Study coordinator: Le Son Tran, Ph.D
- Email: sontran@genesolutions.vn
- Phone: +84705196257
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.