Non Small Cell Lung CancerNCT06167460
Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to TKI in Patients With Advanced NSCLC.
An observational study of Non Small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, run by Gene Solutions at 1 site in Vietnam.
Trial summary
This is an observational study, aiming to investigate whether the ctDNA dynamics analyzed by the K-TrackTM assay could predict early response to Tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung cancer (NSCLC). 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IIIC Non-Small Cell Lung Cancer
- How many people
- 50 participants
- Where
- 1 siteVietnam
- Study dates
- 4 Dec 2023to 1 Dec 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study population will include female and male, aged 18 and older, who are diagnosed with stage IIIB-IV Non-small cell lung cancer and indicated for TKI or TKI combined with chemotherapy. Eligible participants will meet all of the inclusion and exclusion criteria to be recruited into this study.
Who may be able to join
- Patients are diagnosed with advanced non-small cell lung cancer and indicated for TKI (first or second line). TKI combined with chemotherapy is allowed.
- FFPE/FNA sample is available.
- Compliant with treatment protocol.
- Patients consented to participate in the study.
Who cannot join
- Patients already started TKI before enrollment.
- Patients already started chemotherapy before enrollment.
- Medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol.
- Patients did not agree to participate in the studies.
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, 1 recruiting
- Recruiting
Medical Genetics Institute
Ho Chi Minh City
Lan D Nguyen, PhD, +84888843489, lantu@genesolutions.vn
VAN T Le, PhD, +84908145990, vanphan@genesolutions.vn
About this study
Official title: Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to Tyrosine Kinase Inhibitors in Patients With Advanced Non-small Cell Lung Cancer
This is an observational study, aiming to investigate whether the ctDNA dynamics analyzed by the K-TrackTM assay could predict early response to Tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung cancer (NSCLC).
- Determine relationship between ctDNA dynamics and clinical response to TKI,
- No response/progressive disease = ctDNA levels increase from baseline
- Partial response/stable disease = ctDNA levels decrease from baseline
- Complete response = ctDNA clearance.
- Compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.
- Determine relationship between ctDNA dynamics and progression free survival, overall survival.
Read the detailed description
This study is recruiting female and male patients, aged 18 and older:
- Who are diagnosed with advanced non-small cell lung cancer and indicated for TKI (first or second line). TKI combined with chemotherapy is allowed,
- Who have not started TKI / chemotherapy before enrollment,
- Who have no medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol,
- FFPE/FNA sample is available,
- Compliant with treatment protocol,
- Patients consented to participate in the study. As part of the protocol, demographic data, medical and family history, and any relevant prior concomitant medication data will be recorded during follow-up visits. All patients are to be followed for 2 years from enrollment, with CT scan imaging measured every clinical visit for 24 months.
Sample collection:
- 10 mL of peripheral blood (in Streck tubes) is collected for ctDNA analysis at 8 time points: pre-treatment (<10 days before TKI), during TKI every 3 months until 21 months.
- 6-8 sections of formalin-fixed paraffin-embedded (FFPE) tumor samples before TKI/chemotherapy treatment.
- Conditions
- Non Small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IIIC Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Tyrosine Kinase Inhibitors
- Keywords
- Liquid Biopsy, Circulating Tumour DNA, Vietnam
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between ctDNA dynamics and clinical response to TKI
- No response/progressive disease = ctDNA levels increase from baseline
- Partial response/stable disease = ctDNA levels decrease from baseline
- Complete response = ctDNA clearance.
Measured: 24 months following up.
To compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.
- Correlation between ctDNA dynamics and clinical response
- Correlation between RECIST1.1 and clinical response
- Combination of ctDNA dynamics and RECIST v1.1 in the prognosis of clinical response.
Measured: 24 months following up.
To investigate the relationship between ctDNA dynamics and progression free survival, overall survival.
- Correlation between ctDNA dynamics and PFS
- Correlation between ctDNA dynamics and OS.
Measured: 24 months following up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start4 Dec 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gene Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sinh D Nguyen, PhD, Principal investigator, MGI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167460
- Sponsor's protocol ID
- GS_ZTKL
- Status last verified
- Jul 2025
- First submitted
- 21 Nov 2023
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data of this this study may be requested for publication by the journals, sharing anonymized data with suitable study 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/organization than authority in the study.
Publications
Yang J, Gong Y, Lam VK, Shi Y, Guan Y, Zhang Y, Ji L, Chen Y, Zhao Y, Qian F, Chen J, Li P, Zhang F, Wang J, Zhang X, Yang L, Kopetz S, Futreal PA, Zhang J, Yi X, Xia X, Yu P. Deep sequencing of circulating tumor DNA detects molecular residual disease and predicts recurrence in gastric cancer. Cell Death Dis. 2020 May 11;11(5):346. doi: 10.1038/s41419-020-2531-z.
PubMed 32393783Reinert T, Henriksen TV, Christensen E, Sharma S, Salari R, Sethi H, Knudsen M, Nordentoft I, Wu HT, Tin AS, Heilskov Rasmussen M, Vang S, Shchegrova S, Frydendahl Boll Johansen A, Srinivasan R, Assaf Z, Balcioglu M, Olson A, Dashner S, Hafez D, Navarro S, Goel S, Rabinowitz M, Billings P, Sigurjonsson S, Dyrskjot L, Swenerton R, Aleshin A, Laurberg S, Husted Madsen A, Kannerup AS, Stribolt K, Palmelund Krag S, Iversen LH, Gotschalck Sunesen K, Lin CJ, Zimmermann BG, Lindbjerg Andersen C. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019 Aug 1;5(8):1124-1131. doi: 10.1001/jamaoncol.2019.0528.
PubMed 31070691Magbanua MJM, Swigart LB, Wu HT, Hirst GL, Yau C, Wolf DM, Tin A, Salari R, Shchegrova S, Pawar H, Delson AL, DeMichele A, Liu MC, Chien AJ, Tripathy D, Asare S, Lin CJ, Billings P, Aleshin A, Sethi H, Louie M, Zimmermann B, Esserman LJ, van 't Veer LJ. Circulating tumor DNA in neoadjuvant-treated breast cancer reflects response and survival. Ann Oncol. 2021 Feb;32(2):229-239. doi: 10.1016/j.annonc.2020.11.007. Epub 2020 Nov 21.
PubMed 33232761Christensen E, Birkenkamp-Demtroder K, Sethi H, Shchegrova S, Salari R, Nordentoft I, Wu HT, Knudsen M, Lamy P, Lindskrog SV, Taber A, Balcioglu M, Vang S, Assaf Z, Sharma S, Tin AS, Srinivasan R, Hafez D, Reinert T, Navarro S, Olson A, Ram R, Dashner S, Rabinowitz M, Billings P, Sigurjonsson S, Andersen CL, Swenerton R, Aleshin A, Zimmermann B, Agerbaek M, Lin CJ, Jensen JB, Dyrskjot L. Early Detection of Metastatic Relapse and Monitoring of Therapeutic Efficacy by Ultra-Deep Sequencing of Plasma Cell-Free DNA in Patients With Urothelial Bladder Carcinoma. J Clin Oncol. 2019 Jun 20;37(18):1547-1557. doi: 10.1200/JCO.18.02052. Epub 2019 May 6.
PubMed 31059311Coombes RC, Page K, Salari R, Hastings RK, Armstrong A, Ahmed S, Ali S, Cleator S, Kenny L, Stebbing J, Rutherford M, Sethi H, Boydell A, Swenerton R, Fernandez-Garcia D, Gleason KLT, Goddard K, Guttery DS, Assaf ZJ, Wu HT, Natarajan P, Moore DA, Primrose L, Dashner S, Tin AS, Balcioglu M, Srinivasan R, Shchegrova SV, Olson A, Hafez D, Billings P, Aleshin A, Rehman F, Toghill BJ, Hills A, Louie MC, Lin CJ, Zimmermann BG, Shaw JA. Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence. Clin Cancer Res. 2019 Jul 15;25(14):4255-4263. doi: 10.1158/1078-0432.CCR-18-3663. Epub 2019 Apr 16.
PubMed 30992300Labgaa I, Villacorta-Martin C, D'Avola D, Craig AJ, von Felden J, Martins-Filho SN, Sia D, Stueck A, Ward SC, Fiel MI, Mahajan M, Tabrizian P, Thung SN, Ang C, Friedman SL, Llovet JM, Schwartz M, Villanueva A. A pilot study of ultra-deep targeted sequencing of plasma DNA identifies driver mutations in hepatocellular carcinoma. Oncogene. 2018 Jul;37(27):3740-3752. doi: 10.1038/s41388-018-0206-3. Epub 2018 Apr 9.
PubMed 29628508Nguyen HT, Nguyen TV, Nguyen Hoang VA, Tran DH, Le Trinh NA, Le MT, Nguyen Tran TA, Pham TH, Dinh TC, Nguyen TS, Nguyen The KC, Mai H, Chu MT, Pham DH, Nguyen XC, Ngo Ha TM, Nguyen DS, Nguyen DQ, Lu YT, Do Thi TT, Truong DK, Nguyen QT, Nguyen HN, Giang H, Tu LN. Tumor genomic profiling and personalized tracking of circulating tumor DNA in Vietnamese colorectal cancer patients. Front Oncol. 2022 Dec 12;12:1069296. doi: 10.3389/fonc.2022.1069296. eCollection 2022.
PubMed 36578946Nguyen Hoang VA, Nguyen ST, Nguyen TV, Pham TH, Doan PL, Nguyen Thi NT, Nguyen ML, Dinh TC, Pham DH, Nguyen NM, Nguyen DS, Nguyen DQ, Lu YT, Do TTT, Truong DK, Phan MD, Nguyen HN, Giang H, Tu LN. Genetic landscape and personalized tracking of tumor mutations in Vietnamese women with breast cancer. Mol Oncol. 2023 Apr;17(4):598-610. doi: 10.1002/1878-0261.13356. Epub 2023 Jan 15.
PubMed 36495126Wei YF, Huang WT, Liu TC, Shieh JM, Chian CF, Wu MF, Chang CC, Lin CH, Ko JC, Lin CM, Hsia TC. Factors associated with improvement in symptoms and quality of life for first-line EGFR-tyrosine kinase inhibitor treatment in patients with EGFR-mutated non-small-cell lung cancer - A multicenter prospective SMILE study. J Cancer. 2019 Jul 10;10(17):4151-4158. doi: 10.7150/jca.30507. eCollection 2019.
PubMed 31417660Michelotti A, de Scordilli M, Bertoli E, De Carlo E, Del Conte A, Bearz A. NSCLC as the Paradigm of Precision Medicine at Its Finest: The Rise of New Druggable Molecular Targets for Advanced Disease. Int J Mol Sci. 2022 Jun 17;23(12):6748. doi: 10.3390/ijms23126748.
PubMed 35743191Horn L, Whisenant JG, Wakelee H, Reckamp KL, Qiao H, Leal TA, Du L, Hernandez J, Huang V, Blumenschein GR, Waqar SN, Patel SP, Nieva J, Oxnard GR, Sanborn RE, Shaffer T, Garg K, Holzhausen A, Harrow K, Liang C, Lim LP, Li M, Lovly CM. Monitoring Therapeutic Response and Resistance: Analysis of Circulating Tumor DNA in Patients With ALK+ Lung Cancer. J Thorac Oncol. 2019 Nov;14(11):1901-1911. doi: 10.1016/j.jtho.2019.08.003. Epub 2019 Aug 22.
PubMed 31446141Tran HT, Lam VK, Elamin YY, Hong L, Colen R, Elshafeey NA, Hassan ISA, Altan M, Blumenschein GR, Rinsurongkawong W, Rivera MJ, Vasquez ME, Carter BW, Byers LE, Tsao AS, Gibbons DL, Fossella F, Glisson BS, Zhang J, Heymach JV. Clinical Outcomes in Non-Small-Cell Lung Cancer Patients Treated With EGFR-Tyrosine Kinase Inhibitors and Other Targeted Therapies Based on Tumor Versus Plasma Genomic Profiling. JCO Precis Oncol. 2021 Aug 5;5:PO.20.00532. doi: 10.1200/PO.20.00532. eCollection 2021 Aug.
PubMed 34377884Mack PC, Miao J, Redman MW, Moon J, Goldberg SB, Herbst RS, Melnick MA, Walther Z, Hirsch FR, Politi K, Kelly K, Gandara DR. Circulating Tumor DNA Kinetics Predict Progression-Free and Overall Survival in EGFR TKI-Treated Patients with EGFR-Mutant NSCLC (SWOG S1403). Clin Cancer Res. 2022 Sep 1;28(17):3752-3760. doi: 10.1158/1078-0432.CCR-22-0741.
PubMed 35713632Soo RA, Martini JF, van der Wekken AJ, Teraoka S, Ferrara R, Shaw AT, Shepard D, Calella AM, Polli A, Toffalorio F, Tomasini P, Chiu CH, Kowalski DM, Kim HR, Solomon BJ. Early Circulating Tumor DNA Dynamics and Efficacy of Lorlatinib in Patients With Treatment-Naive, Advanced, ALK-Positive NSCLC. J Thorac Oncol. 2023 Nov;18(11):1568-1580. doi: 10.1016/j.jtho.2023.05.021. Epub 2023 Jun 7.
PubMed 37295609Gray JE, Ahn MJ, Oxnard GR, Shepherd FA, Imamura F, Cheng Y, Okamoto I, Cho BC, Lin MC, Wu YL, Majem M, Gautschi O, Boyer M, Bulusu KC, Markovets A, Barrett JC, Hodge R, McKeown A, Hartmaier RJ, Chmielecki J, Papadimitrakopoulou VA, Ramalingam SS. Early Clearance of Plasma Epidermal Growth Factor Receptor Mutations as a Predictor of Outcome on Osimertinib in Advanced Non-Small Cell Lung Cancer; Exploratory Analysis from AURA3 and FLAURA. Clin Cancer Res. 2023 Sep 1;29(17):3340-3351. doi: 10.1158/1078-0432.CCR-22-3146.
PubMed 37379430
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to Tyrosine Kinase Inhibitors in Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06167460
- Acronym / sponsor ID
- GS_ZTKL
- Conditions
- Non Small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IIIC Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Tyrosine Kinase Inhibitors
- Keywords
- Liquid Biopsy, Circulating Tumour DNA, Vietnam
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gene SolutionsIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study, aiming to investigate whether the ctDNA dynamics analyzed by the K-TrackTM assay could predict early response to Tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung cancer (NSCLC).
- Determine relationship between ctDNA dynamics and clinical response to TKI,
- No response/progressive disease = ctDNA levels increase from baseline
- Partial response/stable disease = ctDNA levels decrease from baseline
- Complete response = ctDNA clearance.
- Compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.
- Determine relationship between ctDNA dynamics and progression free survival, overall survival.
Detailed description
This study is recruiting female and male patients, aged 18 and older:
- Who are diagnosed with advanced non-small cell lung cancer and indicated for TKI (first or second line). TKI combined with chemotherapy is allowed,
- Who have not started TKI / chemotherapy before enrollment,
- Who have no medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol,
- FFPE/FNA sample is available,
- Compliant with treatment protocol,
- Patients consented to participate in the study. As part of the protocol, demographic data, medical and family history, and any relevant prior concomitant medication data will be recorded during follow-up visits. All patients are to be followed for 2 years from enrollment, with CT scan imaging measured every clinical visit for 24 months.
Sample collection:
- 10 mL of peripheral blood (in Streck tubes) is collected for ctDNA analysis at 8 time points: pre-treatment (<10 days before TKI), during TKI every 3 months until 21 months.
- 6-8 sections of formalin-fixed paraffin-embedded (FFPE) tumor samples before TKI/chemotherapy treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study population will include female and male, aged 18 and older, who are diagnosed with stage IIIB-IV Non-small cell lung cancer and indicated for TKI or TKI combined with chemotherapy. Eligible participants will meet all of the inclusion and exclusion criteria to be recruited into this study.
Key inclusion criteria (4 listed)
- Patients are diagnosed with advanced non-small cell lung cancer and indicated for TKI (first or second line). TKI combined with chemotherapy is allowed.
- FFPE/FNA sample is available.
- Compliant with treatment protocol.
- Patients consented to participate in the study.
Key exclusion criteria (4 listed)
- Patients already started TKI before enrollment.
- Patients already started chemotherapy before enrollment.
- Medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol.
- Patients did not agree to participate in the studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship between ctDNA dynamics and clinical response to TKI
Time frame: 24 months following up.
* No response/progressive disease = ctDNA levels increase from baseline * Partial response/stable disease = ctDNA levels decrease from baseline * Complete response = ctDNA clearance.
To compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.
Time frame: 24 months following up.
* Correlation between ctDNA dynamics and clinical response * Correlation between RECIST1.1 and clinical response * Combination of ctDNA dynamics and RECIST v1.1 in the prognosis of clinical response.
To investigate the relationship between ctDNA dynamics and progression free survival, overall survival.
Time frame: 24 months following up.
* Correlation between ctDNA dynamics and PFS * Correlation between ctDNA dynamics and OS.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Background: PubMed 32393783Yang J, Gong Y, Lam VK, Shi Y, Guan Y, Zhang Y, Ji L, Chen Y, Zhao Y, Qian F, Chen J, Li P, Zhang F, Wang J, Zhang X, Yang L, Kopetz S, Futreal PA, Zhang J, Yi X, Xia X, Yu P. Deep sequencing of circulating tumor DNA detects molecular residual disease and predicts recurrence in gastric cancer. Cell Death Dis. 2020 May 11;11(5):346. doi: 10.1038/s41419-020-2531-z.
- Background: PubMed 31070691Reinert T, Henriksen TV, Christensen E, Sharma S, Salari R, Sethi H, Knudsen M, Nordentoft I, Wu HT, Tin AS, Heilskov Rasmussen M, Vang S, Shchegrova S, Frydendahl Boll Johansen A, Srinivasan R, Assaf Z, Balcioglu M, Olson A, Dashner S, Hafez D, Navarro S, Goel S, Rabinowitz M, Billings P, Sigurjonsson S, Dyrskjot L, Swenerton R, Aleshin A, Laurberg S, Husted Madsen A, Kannerup AS, Stribolt K, Palmelund Krag S, Iversen LH, Gotschalck Sunesen K, Lin CJ, Zimmermann BG, Lindbjerg Andersen C. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019 Aug 1;5(8):1124-1131. doi: 10.1001/jamaoncol.2019.0528.
- Background: PubMed 33232761Magbanua MJM, Swigart LB, Wu HT, Hirst GL, Yau C, Wolf DM, Tin A, Salari R, Shchegrova S, Pawar H, Delson AL, DeMichele A, Liu MC, Chien AJ, Tripathy D, Asare S, Lin CJ, Billings P, Aleshin A, Sethi H, Louie M, Zimmermann B, Esserman LJ, van 't Veer LJ. Circulating tumor DNA in neoadjuvant-treated breast cancer reflects response and survival. Ann Oncol. 2021 Feb;32(2):229-239. doi: 10.1016/j.annonc.2020.11.007. Epub 2020 Nov 21.
- Background: PubMed 31059311Christensen E, Birkenkamp-Demtroder K, Sethi H, Shchegrova S, Salari R, Nordentoft I, Wu HT, Knudsen M, Lamy P, Lindskrog SV, Taber A, Balcioglu M, Vang S, Assaf Z, Sharma S, Tin AS, Srinivasan R, Hafez D, Reinert T, Navarro S, Olson A, Ram R, Dashner S, Rabinowitz M, Billings P, Sigurjonsson S, Andersen CL, Swenerton R, Aleshin A, Zimmermann B, Agerbaek M, Lin CJ, Jensen JB, Dyrskjot L. Early Detection of Metastatic Relapse and Monitoring of Therapeutic Efficacy by Ultra-Deep Sequencing of Plasma Cell-Free DNA in Patients With Urothelial Bladder Carcinoma. J Clin Oncol. 2019 Jun 20;37(18):1547-1557. doi: 10.1200/JCO.18.02052. Epub 2019 May 6.
- Background: PubMed 30992300Coombes RC, Page K, Salari R, Hastings RK, Armstrong A, Ahmed S, Ali S, Cleator S, Kenny L, Stebbing J, Rutherford M, Sethi H, Boydell A, Swenerton R, Fernandez-Garcia D, Gleason KLT, Goddard K, Guttery DS, Assaf ZJ, Wu HT, Natarajan P, Moore DA, Primrose L, Dashner S, Tin AS, Balcioglu M, Srinivasan R, Shchegrova SV, Olson A, Hafez D, Billings P, Aleshin A, Rehman F, Toghill BJ, Hills A, Louie MC, Lin CJ, Zimmermann BG, Shaw JA. Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence. Clin Cancer Res. 2019 Jul 15;25(14):4255-4263. doi: 10.1158/1078-0432.CCR-18-3663. Epub 2019 Apr 16.
- Background: PubMed 29628508Labgaa I, Villacorta-Martin C, D'Avola D, Craig AJ, von Felden J, Martins-Filho SN, Sia D, Stueck A, Ward SC, Fiel MI, Mahajan M, Tabrizian P, Thung SN, Ang C, Friedman SL, Llovet JM, Schwartz M, Villanueva A. A pilot study of ultra-deep targeted sequencing of plasma DNA identifies driver mutations in hepatocellular carcinoma. Oncogene. 2018 Jul;37(27):3740-3752. doi: 10.1038/s41388-018-0206-3. Epub 2018 Apr 9.
- Background: PubMed 36578946Nguyen HT, Nguyen TV, Nguyen Hoang VA, Tran DH, Le Trinh NA, Le MT, Nguyen Tran TA, Pham TH, Dinh TC, Nguyen TS, Nguyen The KC, Mai H, Chu MT, Pham DH, Nguyen XC, Ngo Ha TM, Nguyen DS, Nguyen DQ, Lu YT, Do Thi TT, Truong DK, Nguyen QT, Nguyen HN, Giang H, Tu LN. Tumor genomic profiling and personalized tracking of circulating tumor DNA in Vietnamese colorectal cancer patients. Front Oncol. 2022 Dec 12;12:1069296. doi: 10.3389/fonc.2022.1069296. eCollection 2022.
- Background: PubMed 36495126Nguyen Hoang VA, Nguyen ST, Nguyen TV, Pham TH, Doan PL, Nguyen Thi NT, Nguyen ML, Dinh TC, Pham DH, Nguyen NM, Nguyen DS, Nguyen DQ, Lu YT, Do TTT, Truong DK, Phan MD, Nguyen HN, Giang H, Tu LN. Genetic landscape and personalized tracking of tumor mutations in Vietnamese women with breast cancer. Mol Oncol. 2023 Apr;17(4):598-610. doi: 10.1002/1878-0261.13356. Epub 2023 Jan 15.
- Background: PubMed 31417660Wei YF, Huang WT, Liu TC, Shieh JM, Chian CF, Wu MF, Chang CC, Lin CH, Ko JC, Lin CM, Hsia TC. Factors associated with improvement in symptoms and quality of life for first-line EGFR-tyrosine kinase inhibitor treatment in patients with EGFR-mutated non-small-cell lung cancer - A multicenter prospective SMILE study. J Cancer. 2019 Jul 10;10(17):4151-4158. doi: 10.7150/jca.30507. eCollection 2019.
- Background: PubMed 35743191Michelotti A, de Scordilli M, Bertoli E, De Carlo E, Del Conte A, Bearz A. NSCLC as the Paradigm of Precision Medicine at Its Finest: The Rise of New Druggable Molecular Targets for Advanced Disease. Int J Mol Sci. 2022 Jun 17;23(12):6748. doi: 10.3390/ijms23126748.
- Background: PubMed 31446141Horn L, Whisenant JG, Wakelee H, Reckamp KL, Qiao H, Leal TA, Du L, Hernandez J, Huang V, Blumenschein GR, Waqar SN, Patel SP, Nieva J, Oxnard GR, Sanborn RE, Shaffer T, Garg K, Holzhausen A, Harrow K, Liang C, Lim LP, Li M, Lovly CM. Monitoring Therapeutic Response and Resistance: Analysis of Circulating Tumor DNA in Patients With ALK+ Lung Cancer. J Thorac Oncol. 2019 Nov;14(11):1901-1911. doi: 10.1016/j.jtho.2019.08.003. Epub 2019 Aug 22.
- Background: PubMed 34377884Tran HT, Lam VK, Elamin YY, Hong L, Colen R, Elshafeey NA, Hassan ISA, Altan M, Blumenschein GR, Rinsurongkawong W, Rivera MJ, Vasquez ME, Carter BW, Byers LE, Tsao AS, Gibbons DL, Fossella F, Glisson BS, Zhang J, Heymach JV. Clinical Outcomes in Non-Small-Cell Lung Cancer Patients Treated With EGFR-Tyrosine Kinase Inhibitors and Other Targeted Therapies Based on Tumor Versus Plasma Genomic Profiling. JCO Precis Oncol. 2021 Aug 5;5:PO.20.00532. doi: 10.1200/PO.20.00532. eCollection 2021 Aug.
- Individual participant dataSharing planned: Yes. Anonymized data of this this study may be requested for publication by the journals, sharing anonymized data with suitable study 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/organization than authority in the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sinh D Nguyen, PhD principal investigator
MGI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, 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 4 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: looking for participants now, 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?
Contact Lan NL Tu, PhD (+84888843489, lantu@genesolutions.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between ctDNA dynamics and clinical response to TKI (time frame: 24 months following up.). The study lists 3 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 NCT06167460, which also lists 15 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.