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

NCT06391749 | Enrolling By Invitation

• 1 other identifier: 04GS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Colon; Cancer, Liver; Cancer, Lung; Cancer, Breast; Cancer, Gastric

Keywords

Early cancer detection; Circulating Tumour DNA; Liquid biopsy; Vietnam; symptomatic; triage

Outcome Measures

Primary Outcomes (2)

• Evaluate the performance of the SPOT-MAS test to detect cancer in symptomatic individuals

  Sensitivity, Specificity, Positive predictive value, Negative predictive value of the SPOT-MAS test

  12 months following enrolment

• Evaluate the ability of the SPOT-MAS test to detect tumor tissue origin

  accuracy of tumor tissue origin identification

  12 months following enrolment

Secondary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include both males and females, aged 18 or above, who have no history of cancer. Participants are recruited and referred to diagnostic pathways according to the signs and symptoms. The eligible participants will have to satisfy all of the inclusion and exclusion criteria to be recruited into this study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gene Solutions: lead
• University of Medicine and Pharmacy at Ho Chi Minh City: collaborator

Study Sites (1)

Medical Genetics Institute

Ho Chi Minh City, Vietnam

Location

Related Publications (7)

• Lam 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 BACKGROUND

• Allaby 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 BACKGROUND

• Boeddinghaus 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 BACKGROUND

• Schrag 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 BACKGROUND

• Nicholson 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 BACKGROUND

• Nguyen 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.

  PMID: 37819044 BACKGROUND

• Nguyen THH, Lu YT, Le VH, Bui VQ, Nguyen LH, Pham NH, Phan TH, Nguyen HT, Tran VS, Bui CV, Vo VK, Nguyen PTN, Dang HHP, Pham VD, Cao VT, Nguyen TD, Nguyen LHD, Phan NM, Nguyen TH, Nguyen VTC, Pham TMQ, Tran VU, Le MP, Vo DH, Tran TMT, Nguyen MN, Nguyen TT, Tieu BL, Nguyen HTP, Truong DYA, Cao CTT, Nguyen VT, Le TLQ, Luong TLA, Doan TKP, Dao TT, Phan CD, Nguyen TX, Pham NT, Nguyen BT, Pham TTT, Le HL, Truong CT, Jasmine TX, Le MC, Phan VB, Truong QB, Tran THL, Huynh MT, Tran TQ, Nguyen ST, Tran V, Tran VK, Nguyen HN, Nguyen DS, Nguyen TQT, Phan TV, Do TT, Truong DK, Tang HS, Phan MD, Giang H, Nguyen HN, Tran LS. Clinical validation of a ctDNA-Based Assay for Multi-Cancer Detection: An Interim Report from a Vietnamese Longitudinal Prospective Cohort Study of 2795 Participants. Cancer Invest. 2023 Feb 6:1-17. doi: 10.1080/07357907.2023.2173773. Online ahead of print.

  PMID: 36719061 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Samples collected from the participants will be processed and analysed the ctDNA to detect cancer in the early stages and to predict the origin of the tumor. The residual blood of this test will be stored in -80 degree of Celcius for further testing to: (i) screen or diagnose cancers; (ii) determine the hosts' genetic factors associated with the risks of cancers

MeSH Terms

Conditions

Colonic Neoplasms; Liver Neoplasms; Lung Neoplasms; Breast Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

VN (1)