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Cancer ColonK-ACCELERATENCT06391749

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

An observational study of Cancer Colon and Cancer, Liver, run by Gene Solutions at 1 site in Vietnam.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer Colon, Cancer, Liver, Cancer, Lung
How many people
1,000 participants
Where
1 siteVietnam
Study dates
30 Jul 2024to Jul 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vietnam1 site

  • Medical Genetics Institute

    Ho Chi Minh City

Other trials in Vietnam

About this study

Official title: K-ACCELERATE: A Multi-center Prospective Trial to Evaluate Clinical Utility of Multi Cancer Early Detection Test as a Triage Test for Symptomatic Participants

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.

Read the 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

Keywords
Early cancer detection, Circulating Tumour DNA, Liquid biopsy, Vietnam, symptomatic, triage
Medical subject headings
Colonic Neoplasms, Liver Neoplasms, Lung Neoplasms, Breast Neoplasms, Stomach Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months following enrolment

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

    accuracy of tumor tissue origin identification

    Measured: 12 months following enrolment

Secondary outcomes (1)

  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

    Positive predictive value, Negative predictive value, Sensitivity and Specificity of the SPOT-MAS test in combination with LRI and HRI tests

    Measured: 12 months following enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2024
  2. Study start30 Jul 2024
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06391749
Sponsor's protocol ID
04GS
Acronym
K-ACCELERATE
Status last verified
Jul 2025
First submitted
25 Apr 2024
Last updated
16 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymised data of this study may be requested for publication by journals. Sharing anonymised data with future similar/suitable studies will be decided by the sponsor, PIs and the authority agency where the data was collected. No identifiable information will be shared with any other person/organisation than authorized in the study.

Publications

  • 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.

    PubMed 25341132

  • 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.

    PubMed 26431865

  • 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.

    PubMed 16491590

  • 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.

    PubMed 37805216

  • 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.

    PubMed 37352875

  • 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.

    PubMed 37819044

  • 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.

    PubMed 36719061

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer Colon and Cancer, Liver, run by Gene Solutions at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the performance of the SPOT-MAS test to detect cancer in symptomatic individuals (time frame: 12 months following enrolment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06391749, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.

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