AzTrials
AzTrials

Lung DiseasesNCT07126626

Validation of the SPOT-MAS Lung Test Using Circulating Tumor DNA for the Detection of Lung Cancer

An observational study of Lung Diseases and Lung Cancer Screening, run by Gene Solutions at 1 site in Vietnam.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is an observational clinical trial, aiming to evaluate the efficacy of the SPOTMAS LUNG (SML) test compared to Low dose CTScan (LDCT)/None contrast CTScan (NCCT) in two distinct risk populations: Cohort A: To demonstrate that SML is concordant with LDCT/NCCT in general population lung cancer screening, including… Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Lung Diseases, Lung Cancer Screening
How many people
1,184 participants
Where
1 siteVietnam
Study dates
18 Aug 2025to 31 Jul 2027
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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Cohort A: Patients visit the hospital and are screened according to inclusion/exclusion criteria and are indicated for routine LDCT or NCCT (Enrollment Date D1, results unknown). Cohort B: Patients visit the hospital and are screened according to inclusion/exclusion criteria and have LDCT or NCCT or CECT results of Lung-RADS 4, valid within 30 days up to the study enrollment date.

Who may be able to join

  • Cohort A
  • Volunteers (participants) aged 50-80 years at the time of consent.
  • 50% smokers with a smoking history of 20 pack-years who currently smoke or have quit within the past 15 years.
  • 50% never-smokers or light smokers (< 20 pack-years or quit > 15 years) who are first- or second-degree relatives of LC patients.
  • Willing to undergo LDCT/NCCT of the chest for lung cancer screening.
  • Willing to consent to an investigational blood draw during the index LDCT/NCCT screening visit and before any invasive procedures or treatment for lung cancer diagnosis.
Show all 14Show fewer
  • Willing to consent to a 1-year follow-up and additional follow-ups as per protocol.
  • Cohort B
  • Subjects aged 50-80 years at the time of consent.
  • 50% smokers with a smoking history of 20 pack-years who currently smoke or have quit within the past 15 years.
  • 50% never-smokers or light smokers (< 20 pack-years or quit > 15 years) who are first- or second-degree relatives of LC patients.
  • Have undergone LDCT/NCCT of the chest for lung cancer screening/diagnosis, including only high-risk lesions (LUNG-RADS 4).
  • Willing to consent to an investigational blood draw before any invasive procedures (CECT/PET-CT/biopsy) or treatment for lung cancer diagnosis.
  • Willing to consent to a 1-year follow-up and additional follow-ups as per protocol.

Who cannot join

  • Subject has a health problem that substantially limits life expectancy and/or the ability or willingness to have curative lung surgery.
  • Subject is undergoing CECT for investigation of highly suspicious symptoms for lung cancer.
  • Pre-existing or history of lung cancer.
  • History of any malignancy (subjects who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study).
  • Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs.
  • Currently receiving treatment for pneumonia.
Show all 11Show fewer
  • Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent.
  • Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
  • Participation in a clinical research study in which an experimental medication and/or medical procedure has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of subject screening.
  • -
  • -

Trial locations and contacts

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

Sinh Nguyen D, PhD. MD contact

+84834105425

sinhnguyen@genesolutions.vn

Vietnam1 site

  • Medical Genetics Institute

    Ho Chi Minh City

    Son Le Tran, PhD, +84705196257, sontran@genesolutions.vn

    Sinh D Nguyen, PhD. MD

Other trials in Vietnam

About this study

Official title: Multi-center Prospective Validation of the SPOT-MAS Lung Test Using Circulating Tumor DNA for the Detection of Lung Cancer

This is an observational clinical trial, aiming to evaluate the efficacy of the SPOTMAS LUNG (SML) test compared to Low dose CTScan (LDCT)/None contrast CTScan (NCCT) in two distinct risk populations:

  • Cohort A: To demonstrate that SML is concordant with LDCT/NCCT in general population lung cancer screening, including low-risk (LRs0-1-2), intermediate-risk (LRs3), and high-risk (LRs4) groups.
  • Cohort B: To validate the sensitivity and specificity of SML in the high-risk group (LRs4).
Read the detailed description

This is a prospective, multi-center cohort study to access the performance of SPOT-MAS Lung (SML) in two different scenarios: lung cancer screening (Cohort A) and lung cancer diagnosis (Cohort B).

Sample size and accuracy analyses were performed independently for the study objectives within each cohort. The minimum sample size for Cohort A is approximately 526 samples. Participants will be randomly selected from the screening population for this study without prior LDCT classification criteria. The minimum sample size for Cohort B is approximately 658 samples. Participants will be selected from individuals who have undergone LDCT/NCCT with LUNG-RADS 4 results.

Each Cohort A or B requires a 50% proportion of smokers and 50% of never-smokers or light-smokers, 10mL blood sample and LDCT/NCCT are collected.

Cohort A: According to current lung cancer screening and diagnosis guidelines, volunteers will undergo the following imaging methods:

Lung-RADS 3: Recommended to have a repeat LDCT after 6 and 12 months. Lung-RADS 0-1-2: Recommended to have a repeat LDCT after 12 months. Lung-RADS 4: Recommended to have contrast-enhanced computed tomography (CECT). Cohort B: According to current lung cancer screening and diagnosis guidelines, the Lung-RADS 4 group will be recommended for contrast-enhanced computed tomography (CECT).

Cohort A and B:

If CECT results show a lesion ≥8mm in the lung, biopsy is recommended, and histopathological results evaluated.

  • If histopathology is malignant/confirms cancer: proceed with treatment. Treatment costs ARE NOT covered by the study.
  • If histopathology is benign: repeat LDCT after 12 months. If CECT results show a lesion <8mm in the lung, or no lesion is seen in the lung, repeat LDCT after 12 months.

LDCT or CECT fee in Month 6 and Month 12 will be covered by this study.

Keywords
SPOT-MAS Lung Test
Medical subject headings
Lung Diseases

What is being measured

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

  1. The overall objective of this study is to assess the performance of SPOT-MAS LUNG (SML) in two different scenarios: lung cancer screening (Cohort A) and lung cancer diagnosis (Cohort B).

    Cohort A • Characteristics: Screening population, including low-risk (LRs0-1-2), intermediate-risk (LRs3), and high-risk (LRs4) patients, taken 10mL blood for SML test.

    Cohort B • Characteristics: High-risk patients (LRs 4), taken 10mL blood for SML test.

    Measured: 24 months

Secondary outcomes (1)

  1. Cohort A: To demonstrate that SML is concordant with LDCT/NCCT in the screening population. Cohort B: To assess the specificity and sensitivity of SML in detecting LC in patients with LRs4.

    Cohort A: The objective of the study is to demonstrate that SML and LDCT have a high level of agreement, with a Cohen's Kappa coefficient greater than 0.81.

    • Endpoint: The level of agreement between SML and LDCT/NCCT. Cohort B: In a previous case-control study, SML demonstrated a specificity of 92% and a sensitivity of 90% [9]. Thus, this study will be considered successful if the lower-bound of the two-sided 95% Wilson CI of SM for LC sensitivity exceeds 80% and the lower-bound of the two-sided 95% Wilson CI of SM for LC specificity exceeds 82%.
    • Endpoint: Specificity and sensitivity of SML.

    Measured: 24 months

Timeline

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

  1. First posted17 Aug 2025
  2. Study start18 Aug 2025 (estimated)
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (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
1,184 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07126626
Sponsor's protocol ID
LUNGCARE
Status last verified
Aug 2025
First submitted
11 Jul 2025
Last updated
17 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Infante MV, Cardillo G. Lung cancer screening in never-smokers: facts and remaining issues. Eur Respir J. 2020 Nov 12;56(5):2002949. doi: 10.1183/13993003.02949-2020. Print 2020 Nov. No abstract available.

    PubMed 33184102

  • Kocher Wulfeck M, Plesner S, Herndon JE 2nd, Christensen JD, Patz EF Jr. Characterizing Lung-RADS category 4 lesions in a university lung cancer screening program. Lung Cancer. 2023 Dec;186:107420. doi: 10.1016/j.lungcan.2023.107420. Epub 2023 Nov 10.

    PubMed 37956610

  • Schulz KF, Grimes DA. Case-control studies: research in reverse. Lancet. 2002 Feb 2;359(9304):431-4. doi: 10.1016/S0140-6736(02)07605-5.

    PubMed 11844534

  • https://doi.org/10.1158/2159-8290.CD-24-0519

  • Hu X, Luo K, Shi H, Yan X, Huang R, Zhao B, Zhang J, Xie D, Zhang W. Integrated 5-hydroxymethylcytosine and fragmentation signatures as enhanced biomarkers in lung cancer. Clin Epigenetics. 2022 Jan 24;14(1):15. doi: 10.1186/s13148-022-01233-7.

    PubMed 35073982

  • Guo W, Chen X, Liu R, Liang N, Ma Q, Bao H, Xu X, Wu X, Yang S, Shao Y, Tan F, Xue Q, Gao S, He J. Sensitive detection of stage I lung adenocarcinoma using plasma cell-free DNA breakpoint motif profiling. EBioMedicine. 2022 Jul;81:104131. doi: 10.1016/j.ebiom.2022.104131. Epub 2022 Jun 30.

    PubMed 35780566

  • http://dx.doi.org/10.1002/mco2.766

  • Jenkins S, Yang JC, Ramalingam SS, Yu K, Patel S, Weston S, Hodge R, Cantarini M, Janne PA, Mitsudomi T, Goss GD. Plasma ctDNA Analysis for Detection of the EGFR T790M Mutation in Patients with Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2017 Jul;12(7):1061-1070. doi: 10.1016/j.jtho.2017.04.003. Epub 2017 Apr 17.

    PubMed 28428148

  • Mouliere F, Chandrananda D, Piskorz AM, Moore EK, Morris J, Ahlborn LB, Mair R, Goranova T, Marass F, Heider K, Wan JCM, Supernat A, Hudecova I, Gounaris I, Ros S, Jimenez-Linan M, Garcia-Corbacho J, Patel K, Ostrup O, Murphy S, Eldridge MD, Gale D, Stewart GD, Burge J, Cooper WN, van der Heijden MS, Massie CE, Watts C, Corrie P, Pacey S, Brindle KM, Baird RD, Mau-Sorensen M, Parkinson CA, Smith CG, Brenton JD, Rosenfeld N. Enhanced detection of circulating tumor DNA by fragment size analysis. Sci Transl Med. 2018 Nov 7;10(466):eaat4921. doi: 10.1126/scitranslmed.aat4921.

    PubMed 30404863

  • Snyder MW, Kircher M, Hill AJ, Daza RM, Shendure J. Cell-free DNA Comprises an In Vivo Nucleosome Footprint that Informs Its Tissues-Of-Origin. Cell. 2016 Jan 14;164(1-2):57-68. doi: 10.1016/j.cell.2015.11.050.

    PubMed 26771485

  • Weiss G, Schlegel A, Kottwitz D, Konig T, Tetzner R. Validation of the SHOX2/PTGER4 DNA Methylation Marker Panel for Plasma-Based Discrimination between Patients with Malignant and Nonmalignant Lung Disease. J Thorac Oncol. 2017 Jan;12(1):77-84. doi: 10.1016/j.jtho.2016.08.123. Epub 2016 Aug 18.

    PubMed 27544059

  • Johnson DA, Barclay RL, Mergener K, Weiss G, Konig T, Beck J, Potter NT. Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study. PLoS One. 2014 Jun 5;9(6):e98238. doi: 10.1371/journal.pone.0098238. eCollection 2014.

    PubMed 24901436

  • Ehrlich M. DNA hypomethylation in cancer cells. Epigenomics. 2009 Dec;1(2):239-59. doi: 10.2217/epi.09.33.

    PubMed 20495664

  • McCabe MT, Brandes JC, Vertino PM. Cancer DNA methylation: molecular mechanisms and clinical implications. Clin Cancer Res. 2009 Jun 15;15(12):3927-37. doi: 10.1158/1078-0432.CCR-08-2784. Epub 2009 Jun 9.

    PubMed 19509173

  • Pecuchet N, Zonta E, Didelot A, Combe P, Thibault C, Gibault L, Lours C, Rozenholc Y, Taly V, Laurent-Puig P, Blons H, Fabre E. Base-Position Error Rate Analysis of Next-Generation Sequencing Applied to Circulating Tumor DNA in Non-Small Cell Lung Cancer: A Prospective Study. PLoS Med. 2016 Dec 27;13(12):e1002199. doi: 10.1371/journal.pmed.1002199. eCollection 2016 Dec.

    PubMed 28027313

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Diseases and Lung Cancer Screening, 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 14 inclusion and 11 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: opening soon, as of the sponsor's last update on 17 Aug 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?

Contact Sinh Nguyen D, PhD. MD (+84834105425, sinhnguyen@genesolutions.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The overall objective of this study is to assess the performance of SPOT-MAS LUNG (SML) in two different scenarios: lung cancer screening (Cohort A) and lung cancer diagnosis (Cohort B). (time frame: 24 months). 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 NCT07126626, which also lists 63 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 17 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in