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

Recruiting

• Conditions: Cancer Colon; Cancer, Lung; Cancer, Breast; Cancer, Gastric; Cancer, Liver

• Registration Number: NCT06391749
• Lead Sponsor: Gene Solutions

Brief 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

Study Timeline

• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-30
• Status Verified: 2024-05
• Study Start: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-05
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the performance of the SPOT-MAS test to detect cancer in symptomatic individuals	12 months following enrolment	Sensitivity, Specificity, Positive predictive value, Negative predictive value of the SPOT-MAS test
Evaluate the ability of the SPOT-MAS test to detect tumor tissue origin	12 months following enrolment	accuracy of tumor tissue origin identification

Secondary Outcome Measures

Name	Time	Method
Assess the feasibility of using SPOT-MAS as a triage test to assist in decision-making for follow-up high-resolution imaging or tissue biopsy procedures	12 months following enrolment	Positive predictive value, Negative predictive value, Sensitivity and Specificity of the SPOT-MAS test in combination with LRI and HRI tests

Trial Locations

Locations (1)

Medical Genetics Institute; 🇻🇳 Ho Chi Minh City, Vietnam