Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer Colon | — | UNRESOLVED | — |
| Cancer, Gastric | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Cancer, Liver | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Cancer, Lung | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Evaluate the performance of the SPOT-MAS test to detect cancer in symptomatic individuals
- timeFrame
- 12 months following enrolment
- description
- Sensitivity, Specificity, Positive predictive value, Negative predictive value of the SPOT-MAS test
- measure
- Evaluate the ability of the SPOT-MAS test to detect tumor tissue origin
- timeFrame
- 12 months following enrolment
- description
- accuracy of tumor tissue origin identification
Secondary outcomes (1)
- measure
- 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
- timeFrame
- 12 months following enrolment
- description
- Positive predictive value, Negative predictive value, Sensitivity and Specificity of the SPOT-MAS test in combination with LRI and HRI tests
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDLam DL, Pandharipande PV, Lee JM, Lehman CD, Lee CI. Imaging-based screening: understanding the controversies. AJR Am J Roentgenol. 2014 Nov;203(5):952-6. doi: 10.2214/AJR.14.13049. PMID 25341132
- BACKGROUNDAllaby M. Referral of suspected cancers: the NICE approach. Lancet Oncol. 2015 Sep;16(12):1229-30. doi: 10.1016/S1470-2045(15)00279-X. No abstract available. PMID 26431865
- BACKGROUNDBoeddinghaus I, Johnson SR. Serial biopsies/fine-needle aspirates and their assessment. Methods Mol Med. 2006;120:29-41. doi: 10.1385/1-59259-969-9:29. PMID 16491590
- BACKGROUNDSchrag D, Beer TM, McDonnell CH 3rd, Nadauld L, Dilaveri CA, Reid R, Marinac CR, Chung KC, Lopatin M, Fung ET, Klein EA. Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023 Oct 7;402(10409):1251-1260. doi: 10.1016/S0140-6736(23)01700-2. PMID 37805216
- BACKGROUNDNicholson BD, Oke J, Virdee PS, Harris DA, O'Doherty C, Park JE, Hamady Z, Sehgal V, Millar A, Medley L, Tonner S, Vargova M, Engonidou L, Riahi K, Luan Y, Hiom S, Kumar H, Nandani H, Kurtzman KN, Yu LM, Freestone C, Pearson S, Hobbs FR, Perera R, Middleton MR. Multi-cancer early detection test in symptomatic patients referred for cancer investigation in England and Wales (SYMPLIFY): a large-scale, observational cohort study. Lancet Oncol. 2023 Jul;24(7):733-743. doi: 10.1016/S1470-2045(23)00277-2. Epub 2023 Jun 20. PMID 37352875
- BACKGROUNDNguyen VTC, Nguyen TH, Doan NNT, Pham TMQ, Nguyen GTH, Nguyen TD, Tran TTT, Vo DL, Phan TH, Jasmine TX, Nguyen VC, Nguyen HT, Nguyen TV, Nguyen THH, Huynh LAK, Tran TH, Dang QT, Doan TN, Tran AM, Nguyen VH, Nguyen VTA, Ho LMQ, Tran QD, Pham TTT, Ho TD, Nguyen BT, Nguyen TNV, Nguyen TD, Phu DTB, Phan BHH, Vo TL, Nai THT, Tran TT, Truong MH, Tran NC, Le TK, Tran THT, Duong ML, Bach HPT, Kim VV, Pham TA, Tran DH, Le TNA, Pham TVN, Le MT, Vo DH, Tran TMT, Nguyen MN, Van TTV, Nguyen AN, Tran TT, Tran VU, Le MP, Do TT, Phan TV, Nguyen HL, Nguyen DS, Cao VT, Do TT, Truong DK, Tang HS, Giang H, Nguyen HN, Phan MD, Tran LS. Multimodal analysis of methylomics and fragmentomics in plasma cell-free DNA for multi-cancer early detection and localization. Elife. 2023 Oct 11;12:RP89083. doi: 10.7554/eLife.89083.