Metastatic CancersGS_ZKMNCT06929910
Assessing Systemic Treatment and ctDNA Monitoring Efficacy in Metastatic Cancer Patients Using K4Care Testing.
An observational study of Metastatic Cancers, run by Gene Solutions at 1 site in Vietnam.
Trial summary
The goal of this observational study is to investigate the real-world treatment landscape of patients with metastatic cancer and determine the role of ctDNA in monitoring treatment response in patients with metastatic cancer who have undergone K4Care testing Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Cancers
- How many people
- 200 participants
- Where
- 1 siteVietnam
- Study dates
- 9 Apr 2025to 30 Jun 2027
- How long will I take part?
- 12 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with metastatic cancer who have had tumor tissue sequencing and have genetic mutation data from the K4Care test at Gene Solutions between [month/year] and [month/year], who consent to participate in the study and allow the use of their clinical and sequencing data for future research purposes, will be included. These patients will also receive free ctDNA monitoring using the K-Track N assay for 12 months.
Who may be able to join
- Pathological and imaging confirmation of metastatic or progressive stage IV cancer.
- Consent to the use of their clinical data.
- Diagnosis of one of the following common solid tumor types: lung, colorectal, breast, gastric, or cancer of unknown primary origin.
- Prior K4Care testing to identify tumor tissue (FFPE) mutations and consent to the use of their sequencing data.
Who cannot join
- Refusal to participate in the study.
- Absence of prior K4Care testing.
- Diagnosis of early-stage cancer or hematologic malignancy.
- Refusal to provide clinical information or blood samples.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lan N Tu, PhD contact
Vietnam1 site, 1 recruiting
- Recruiting
Medical Genetics Institute
Ho Chi Minh City, Hồ Chí Minh
Lan N Tu, PhD., +84 888843489, lantu@genesolutions.vn
HCMC
About this study
Official title: Evaluation of Systemic Therapy and the Effectiveness of Circulating Tumor DNA (ctDNA) Assays in Monitoring Treatment Response in Patients With Metastatic Cancer Undergoing K4Care Testing
The goal of this observational study is to investigate the real-world treatment landscape of patients with metastatic cancer and determine the role of ctDNA in monitoring treatment response in patients with metastatic cancer who have undergone K4Care testing
Read the detailed description
Study design: This is a prospective, longitudinal, non-interventional study. Samples will be collected from patients with metastatic cancer who have undergone K4Care testing at Gene Solutions from 03/2025 to 03/2026.
- Definition:
- Progression-free survival (PFS): The time from the start of treatment until disease progression, defined as the appearance of new tumor lesions or the spread of existing lesions to other organs or body parts.
- Overall survival (OS): The time from the start of the study (for non-randomized clinical trials) until death from any cause.
- Cell-free DNA (cfDNA) refers to DNA fragments released from cells into the bloodstream, with an average size of approximately 170 bp. A recent study showed that the concentration of cfDNA in the serum of cancer patients is elevated compared to healthy individuals. Circulating tumor DNA (ctDNA) refers to cfDNA released from cancer cells and carries tumor-associated mutations. The proportion of ctDNA within total cfDNA in cancer patients is highly variable, ranging from over 25% to as low as 0.01% (meaning that for every 10,000 cfDNA molecules in the blood, only 1 ctDNA molecule is released from cancer cells). This ratio is also known as the mutation allele fraction (MAF). MAF varies depending on the type and stage of cancer. The later the stage of the disease, the larger the tumor, and the more ctDNA is released into the blood. The presence of ctDNA in the serum indicates the presence of cancer in the body at the cellular level.
Due to the specificity of ctDNA for cancer, the correlation between ctDNA concentration and tumor size is less affected by other factors. Numerous studies have demonstrated that ctDNA levels change during treatment and correlate with early tumor response, which can be used as a companion biomarker and complement imaging response monitoring in patients treated with immunotherapy. Therefore, many studies have used ctDNA as a potential marker in monitoring tumor response in radical surgery, neoadjuvant chemoradiation, and evaluating treatment response in metastatic patients. NGS technology has brought tremendous value to the identification and treatment of cancer in recent years, helping to prolong the survival of patients and support the development of appropriate treatments for each patient with specific mutations. In addition, gene sequencing technology allows for the accurate detection of cancer-causing mutations in cfDNA samples, thereby identifying the composition of extracellular ctDNA released from the tumor.
- Blood sample: Each participant will have two times of 10mL blood sample collections, 1st blood sample collection is on the enrollment date and the 2nd blood sample collection is on the follow up visit date, from 3-6 months after the enrollment date or according to any participant follow-up visit during the study conduct.
- Clinical information to be collected: will be collected and supplemented (if missing) during the patient's follow-up visits as scheduled by the physician. The information to be collected includes:
- Basic patient demographics and medical history: age; sex; medical history (personal/family, viral infection status); diagnosis: time of diagnosis, cancer type (primary, secondary, metastatic), stage, location, histology, and other biochemical tests.
- Pathological results, immunohistochemical results, and biopsy site.
- Treatment regimen information: treatment types (surgery/chemotherapy/radiotherapy/targeted therapy), time points (start, mid-treatment, end of treatment):
- Curative surgery
- TKI/ICI or Chemotherapy for metastatic stage
- Palliative treatment for metastatic stage
- Patient status: RECIST 1.1 response assessment at time points of Progressive Disease, Stable Disease, Partial Response, and Complete Response, based on the clinical physician's assessment documented in the medical record and accompanied by imaging (if available).
- Time of progression and metastatic site
- Survival status (alive or deceased). Cause of death. Time of death.
- Information regarding death: the cause of death to evaluate whether it is related to cancer complications.
- Time of CT/MRI imaging, results, and clinical physician's interpretation (images can be provided if available)
- Conditions
- Metastatic Cancers
- Keywords
- ctDNA, metastatic cancer
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
This study aims to evaluate the correlation between ctDNA clearance and treatment response in metastatic cancer:
- ctDNA clearance during and after treatment will reflect the patient's response to the treatment regimen.
- Persistent positive ctDNA during and after treatment will reflect the patient's non-response to the treatment regimen and disease progression.
According to current scientific reports, this correlation is independent of cancer type and treatment regimen. Moreover, this is a preliminary, observational, and descriptive statistical study. The sample size for each cancer type depends on the actual number of patients tested at Gene Solutions. Therefore, this study is not limited to a specific cancer type; all patients with metastatic cancer will be included in the analysis (similar to others design. With an average treatment response rate in the metastatic stage of 10-50%, a sample size of 200 patients will allow us to collect data for at least 20 patients.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start9 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Metastatic CancersStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Gene Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Medical Genetics Institute (MGI) of HCMC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929910
- Sponsor's protocol ID
- GS_ZKM
- Acronym
- GS_ZKM
- Status last verified
- Jul 2025
- First submitted
- 8 Apr 2025
- 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
Kansara M, Bhardwaj N, Thavaneswaran S, Xu C, Lee JK, Chang LB, Madison RW, Lin F, Hsu E, Patel VK, Aleshin A, Oxnard GR, Simes J, Nimeiri H, Thomas DM. Early circulating tumor DNA dynamics as a pan-tumor biomarker for long-term clinical outcome in patients treated with durvalumab and tremelimumab. Mol Oncol. 2023 Feb;17(2):298-311. doi: 10.1002/1878-0261.13349. Epub 2022 Dec 13.
PubMed 36426653Bratman SV, Yang SYC, Iafolla MAJ, Liu Z, Hansen AR, Bedard PL, Lheureux S, Spreafico A, Razak AA, Shchegrova S, Louie M, Billings P, Zimmermann B, Sethi H, Aleshin A, Torti D, Marsh K, Eagles J, Cirlan I, Hanna Y, Clouthier DL, Lien SC, Ohashi PS, Xu W, Siu LL, Pugh TJ. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nat Cancer. 2020 Sep;1(9):873-881. doi: 10.1038/s43018-020-0096-5. Epub 2020 Aug 3.
PubMed 35121950Cabel L, Riva F, Servois V, Livartowski A, Daniel C, Rampanou A, Lantz O, Romano E, Milder M, Buecher B, Piperno-Neumann S, Bernard V, Baulande S, Bieche I, Pierga JY, Proudhon C, Bidard FC. Circulating tumor DNA changes for early monitoring of anti-PD1 immunotherapy: a proof-of-concept study. Ann Oncol. 2017 Aug 1;28(8):1996-2001. doi: 10.1093/annonc/mdx212.
PubMed 28459943Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.
PubMed 24553385Shuel SL. Targeted cancer therapies: Clinical pearls for primary care. Can Fam Physician. 2022 Jul;68(7):515-518. doi: 10.46747/cfp.6807515. No abstract available.
PubMed 35831091Kavun A, Veselovsky E, Lebedeva A, Belova E, Kuznetsova O, Yakushina V, Grigoreva T, Mileyko V, Fedyanin M, Ivanov M. Microsatellite Instability: A Review of Molecular Epidemiology and Implications for Immune Checkpoint Inhibitor Therapy. Cancers (Basel). 2023 Apr 13;15(8):2288. doi: 10.3390/cancers15082288.
PubMed 37190216Devarakonda S, Rotolo F, Tsao MS, Lanc I, Brambilla E, Masood A, Olaussen KA, Fulton R, Sakashita S, McLeer-Florin A, Ding K, Le Teuff G, Shepherd FA, Pignon JP, Graziano SL, Kratzke R, Soria JC, Seymour L, Govindan R, Michiels S. Tumor Mutation Burden as a Biomarker in Resected Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Oct 20;36(30):2995-3006. doi: 10.1200/JCO.2018.78.1963. Epub 2018 Aug 14.
PubMed 30106638Catalano M, Iannone LF, Nesi G, Nobili S, Mini E, Roviello G. Immunotherapy-related biomarkers: Confirmations and uncertainties. Crit Rev Oncol Hematol. 2023 Dec;192:104135. doi: 10.1016/j.critrevonc.2023.104135. Epub 2023 Sep 17.
PubMed 37717881Das S, Dey MK, Devireddy R, Gartia MR. Biomarkers in Cancer Detection, Diagnosis, and Prognosis. Sensors (Basel). 2023 Dec 20;24(1):37. doi: 10.3390/s24010037.
PubMed 38202898de Biase D, Fassan M, Malapelle U. Next-Generation Sequencing in Tumor Diagnosis and Treatment. Diagnostics (Basel). 2020 Nov 17;10(11):962. doi: 10.3390/diagnostics10110962.
PubMed 33212911Debela DT, Muzazu SG, Heraro KD, Ndalama MT, Mesele BW, Haile DC, Kitui SK, Manyazewal T. New approaches and procedures for cancer treatment: Current perspectives. SAGE Open Med. 2021 Aug 12;9:20503121211034366. doi: 10.1177/20503121211034366. eCollection 2021.
PubMed 34408877Anand U, Dey A, Chandel AKS, Sanyal R, Mishra A, Pandey DK, De Falco V, Upadhyay A, Kandimalla R, Chaudhary A, Dhanjal JK, Dewanjee S, Vallamkondu J, Perez de la Lastra JM. Cancer chemotherapy and beyond: Current status, drug candidates, associated risks and progress in targeted therapeutics. Genes Dis. 2022 Mar 18;10(4):1367-1401. doi: 10.1016/j.gendis.2022.02.007. eCollection 2023 Jul.
PubMed 37397557
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
- Evaluation of Systemic Therapy and the Effectiveness of Circulating Tumor DNA (ctDNA) Assays in Monitoring Treatment Response in Patients With Metastatic Cancer Undergoing K4Care Testing
- ClinicalTrials.gov ID
- NCT06929910
- Acronym / sponsor ID
- GS_ZKM / GS_ZKM
- Conditions
- Metastatic Cancers
- Keywords
- ctDNA, metastatic cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Gene SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- The Medical Genetics Institute (MGI) of HCMC
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Apr 2025 (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.
The goal of this observational study is to investigate the real-world treatment landscape of patients with metastatic cancer and determine the role of ctDNA in monitoring treatment response in patients with metastatic cancer who have undergone K4Care testing
Detailed description
Study design: This is a prospective, longitudinal, non-interventional study. Samples will be collected from patients with metastatic cancer who have undergone K4Care testing at Gene Solutions from 03/2025 to 03/2026.
- Definition:
- Progression-free survival (PFS): The time from the start of treatment until disease progression, defined as the appearance of new tumor lesions or the spread of existing lesions to other organs or body parts.
- Overall survival (OS): The time from the start of the study (for non-randomized clinical trials) until death from any cause.
- Cell-free DNA (cfDNA) refers to DNA fragments released from cells into the bloodstream, with an average size of approximately 170 bp. A recent study showed that the concentration of cfDNA in the serum of cancer patients is elevated compared to healthy individuals. Circulating tumor DNA (ctDNA) refers to cfDNA released from cancer cells and carries tumor-associated mutations. The proportion of ctDNA within total cfDNA in cancer patients is highly variable, ranging from over 25% to as low as 0.01% (meaning that for every 10,000 cfDNA molecules in the blood, only 1 ctDNA molecule is released from cancer cells). This ratio is also known as the mutation allele fraction (MAF). MAF varies depending on the type and stage of cancer. The later the stage of the disease, the larger the tumor, and the more ctDNA is released into the blood. The presence of ctDNA in the serum indicates the presence of cancer in the body at the cellular level.
Due to the specificity of ctDNA for cancer, the correlation between ctDNA concentration and tumor size is less affected by other factors. Numerous studies have demonstrated that ctDNA levels change during treatment and correlate with early tumor response, which can be used as a companion biomarker and complement imaging response monitoring in patients treated with immunotherapy. Therefore, many studies have used ctDNA as a potential marker in monitoring tumor response in radical surgery, neoadjuvant chemoradiation, and evaluating treatment response in metastatic patients. NGS technology has brought tremendous value to the identification and treatment of cancer in recent years, helping to prolong the survival of patients and support the development of appropriate treatments for each patient with specific mutations. In addition, gene sequencing technology allows for the accurate detection of cancer-causing mutations in cfDNA samples, thereby identifying the composition of extracellular ctDNA released from the tumor.
- Blood sample: Each participant will have two times of 10mL blood sample collections, 1st blood sample collection is on the enrollment date and the 2nd blood sample collection is on the follow up visit date, from 3-6 months after the enrollment date or according to any participant follow-up visit during the study conduct.
- Clinical information to be collected: will be collected and supplemented (if missing) during the patient's follow-up visits as scheduled by the physician. The information to be collected includes:
- Basic patient demographics and medical history: age; sex; medical history (personal/family, viral infection status); diagnosis: time of diagnosis, cancer type (primary, secondary, metastatic), stage, location, histology, and other biochemical tests.
- Pathological results, immunohistochemical results, and biopsy site.
- Treatment regimen information: treatment types (surgery/chemotherapy/radiotherapy/targeted therapy), time points (start, mid-treatment, end of treatment):
- Curative surgery
- TKI/ICI or Chemotherapy for metastatic stage
- Palliative treatment for metastatic stage
- Patient status: RECIST 1.1 response assessment at time points of Progressive Disease, Stable Disease, Partial Response, and Complete Response, based on the clinical physician's assessment documented in the medical record and accompanied by imaging (if available).
- Time of progression and metastatic site
- Survival status (alive or deceased). Cause of death. Time of death.
- Information regarding death: the cause of death to evaluate whether it is related to cancer complications.
- Time of CT/MRI imaging, results, and clinical physician's interpretation (images can be provided if available)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with metastatic cancer who have had tumor tissue sequencing and have genetic mutation data from the K4Care test at Gene Solutions between [month/year] and [month/year], who consent to participate in the study and allow the use of their clinical and sequencing data for future research purposes, will be included. These patients will also receive free ctDNA monitoring using the K-Track N assay for 12 months.
Key inclusion criteria (4 listed)
- Pathological and imaging confirmation of metastatic or progressive stage IV cancer.
- Consent to the use of their clinical data.
- Diagnosis of one of the following common solid tumor types: lung, colorectal, breast, gastric, or cancer of unknown primary origin.
- Prior K4Care testing to identify tumor tissue (FFPE) mutations and consent to the use of their sequencing data.
Key exclusion criteria (4 listed)
- Refusal to participate in the study.
- Absence of prior K4Care testing.
- Diagnosis of early-stage cancer or hematologic malignancy.
- Refusal to provide clinical information or blood samples.
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
This study aims to evaluate the correlation between ctDNA clearance and treatment response in metastatic cancer:
Time frame: 18 months
* ctDNA clearance during and after treatment will reflect the patient's response to the treatment regimen. * Persistent positive ctDNA during and after treatment will reflect the patient's non-response to the treatment regimen and disease progression. According to current scientific reports, this correlation is independent of cancer type and treatment regimen. Moreover, this is a preliminary, observational, and descriptive statistical study. The sample size for each cancer type depends on the actual number of patients tested at Gene Solutions. Therefore, this study is not limited to a specific cancer type; all patients with metastatic cancer will be included in the analysis (similar to others design. With an average treatment response rate in the metastatic stage of 10-50%, a sample size of 200 patients will allow us to collect data for at least 20 patients.
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 36426653Kansara M, Bhardwaj N, Thavaneswaran S, Xu C, Lee JK, Chang LB, Madison RW, Lin F, Hsu E, Patel VK, Aleshin A, Oxnard GR, Simes J, Nimeiri H, Thomas DM. Early circulating tumor DNA dynamics as a pan-tumor biomarker for long-term clinical outcome in patients treated with durvalumab and tremelimumab. Mol Oncol. 2023 Feb;17(2):298-311. doi: 10.1002/1878-0261.13349. Epub 2022 Dec 13.
- Background: PubMed 35121950Bratman SV, Yang SYC, Iafolla MAJ, Liu Z, Hansen AR, Bedard PL, Lheureux S, Spreafico A, Razak AA, Shchegrova S, Louie M, Billings P, Zimmermann B, Sethi H, Aleshin A, Torti D, Marsh K, Eagles J, Cirlan I, Hanna Y, Clouthier DL, Lien SC, Ohashi PS, Xu W, Siu LL, Pugh TJ. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nat Cancer. 2020 Sep;1(9):873-881. doi: 10.1038/s43018-020-0096-5. Epub 2020 Aug 3.
- Background: PubMed 28459943Cabel L, Riva F, Servois V, Livartowski A, Daniel C, Rampanou A, Lantz O, Romano E, Milder M, Buecher B, Piperno-Neumann S, Bernard V, Baulande S, Bieche I, Pierga JY, Proudhon C, Bidard FC. Circulating tumor DNA changes for early monitoring of anti-PD1 immunotherapy: a proof-of-concept study. Ann Oncol. 2017 Aug 1;28(8):1996-2001. doi: 10.1093/annonc/mdx212.
- Background: PubMed 24553385Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.
- Background: PubMed 35831091Shuel SL. Targeted cancer therapies: Clinical pearls for primary care. Can Fam Physician. 2022 Jul;68(7):515-518. doi: 10.46747/cfp.6807515. No abstract available.
- Background: PubMed 37190216Kavun A, Veselovsky E, Lebedeva A, Belova E, Kuznetsova O, Yakushina V, Grigoreva T, Mileyko V, Fedyanin M, Ivanov M. Microsatellite Instability: A Review of Molecular Epidemiology and Implications for Immune Checkpoint Inhibitor Therapy. Cancers (Basel). 2023 Apr 13;15(8):2288. doi: 10.3390/cancers15082288.
- Background: PubMed 30106638Devarakonda S, Rotolo F, Tsao MS, Lanc I, Brambilla E, Masood A, Olaussen KA, Fulton R, Sakashita S, McLeer-Florin A, Ding K, Le Teuff G, Shepherd FA, Pignon JP, Graziano SL, Kratzke R, Soria JC, Seymour L, Govindan R, Michiels S. Tumor Mutation Burden as a Biomarker in Resected Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Oct 20;36(30):2995-3006. doi: 10.1200/JCO.2018.78.1963. Epub 2018 Aug 14.
- Background: PubMed 37717881Catalano M, Iannone LF, Nesi G, Nobili S, Mini E, Roviello G. Immunotherapy-related biomarkers: Confirmations and uncertainties. Crit Rev Oncol Hematol. 2023 Dec;192:104135. doi: 10.1016/j.critrevonc.2023.104135. Epub 2023 Sep 17.
- Background: PubMed 38202898Das S, Dey MK, Devireddy R, Gartia MR. Biomarkers in Cancer Detection, Diagnosis, and Prognosis. Sensors (Basel). 2023 Dec 20;24(1):37. doi: 10.3390/s24010037.
- Background: PubMed 33212911de Biase D, Fassan M, Malapelle U. Next-Generation Sequencing in Tumor Diagnosis and Treatment. Diagnostics (Basel). 2020 Nov 17;10(11):962. doi: 10.3390/diagnostics10110962.
- Background: PubMed 34408877Debela DT, Muzazu SG, Heraro KD, Ndalama MT, Mesele BW, Haile DC, Kitui SK, Manyazewal T. New approaches and procedures for cancer treatment: Current perspectives. SAGE Open Med. 2021 Aug 12;9:20503121211034366. doi: 10.1177/20503121211034366. eCollection 2021.
- Background: PubMed 37397557Anand U, Dey A, Chandel AKS, Sanyal R, Mishra A, Pandey DK, De Falco V, Upadhyay A, Kandimalla R, Chaudhary A, Dhanjal JK, Dewanjee S, Vallamkondu J, Perez de la Lastra JM. Cancer chemotherapy and beyond: Current status, drug candidates, associated risks and progress in targeted therapeutics. Genes Dis. 2022 Mar 18;10(4):1367-1401. doi: 10.1016/j.gendis.2022.02.007. eCollection 2023 Jul.
- 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.
Lan N Tu, PhD contact
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 Metastatic Cancers, 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 Sinh D Nguyen, PhD. MD (+84 834105425, sinhnguyen@genesolutions.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This study aims to evaluate the correlation between ctDNA clearance and treatment response in metastatic cancer: (time frame: 18 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 NCT06929910, which also lists 12 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.