Lung CancerLM2NCT06105177
Implementation of Up-front ctDNA Into Lung Cancer Care and Development of Liquid Biopsy-based Decision Support Models - LM² Study
An observational study of Lung Cancer, run by Catharina Ziekenhuis Eindhoven at 5 sites in Netherlands.
Trial summary
Despite scientific evidence, use of liquid biopsy (LB) in diagnosis and monitoring of lung cancer (LC) is limited since it requires major changes in diagnostic and care pathways. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 800 participants
- Where
- 5 sitesNetherlands
- Study dates
- 31 Oct 2023to Oct 2026
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 800 individuals, >18 years of age, suspected of lung cancer and referred to a lung physician in one of the participating centers are included in the study.
Who may be able to join
- Aged 18 or above and suspected of having lung cancer
Who cannot join
- Presence of another malignant tumor, i.e. diagnosed with a tumor in the past 5 years
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites, 5 recruiting
- Recruiting
Catharina Ziekenhuis Eindhoven
Eindhoven, North Brabant, 5623EJ
Hao Cao, MSc, +31402398644, hao.cao@catharinaziekenhuis.nl
- Not yet recruiting
St. Anna Ziekenhuis
Geldrop, North Brabant, 5664EH
Gerben Stege, MD, PhD
- Not yet recruiting
Zuyderland Medical Center
Heerlen, Limburg, 6419PC
Michiel Gronenschild, MD
- Not yet recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6229HX
Lizza Hendriks, MD, PhD
- Not yet recruiting
Máxima Medisch Centrum
Veldhoven, North Brabant, 5504DB
Magdolen El Soud-Youssef, MD
About this study
Official title: Implementation of Up-front ctDNA Analysis Into Lung Cancer Care and Development of Liquid Biopsy-based Decision Support Models - the Lungmarker² Study
Despite scientific evidence, use of liquid biopsy (LB) in diagnosis and monitoring of lung cancer (LC) is limited since it requires major changes in diagnostic and care pathways. Analyzing tumor markers (TMs), circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in blood (LB) can inform about the nature of the tumor, the most appropriate therapy, therapy response and resistance.
Lungmarker2 is a multicenter, prospective, implementation and diagnostic cohort study. This study aims to implement up-front ctDNA analysis ('plasma first approach') into routine diagnostic work-up of all advanced stage LC patients in the Southeast of the Netherlands (the participating hospitals in the OncoZON region). Thereby, additional information about the molecular make-up of the tumor becomes available, the number of tissue Next-Generation Sequencing (NGS) analyses will decrease and time to therapeutic decision making is shortened. Next, using ctDNA, TM and other information, multi-parametric decision support models are built and validated that may support diagnosis, predict the outcome of the next imaging procedure and progression-free survival during follow-up. The final goal is to develop a super-resolution microscopy test that can detect PD-L1 expression on CTCs.
Read the detailed description
RATIONALE: Despite scientific evidence, use of liquid biopsy (LB) in diagnosis and monitoring of lung cancer (LC) is limited since it requires major changes in diagnostic and care pathways. Analyzing tumor markers (TMs), circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in blood (LB) can inform about the nature of the tumor, the most appropriate therapy, therapy response and resistance.
OBJECTIVE: To implement up-front ctDNA analysis ('plasma first approach') into routine diagnostic work-up of all advanced stage LC patients in the Southeast of the Netherlands (the participating hospitals in the OncoZON region) and to thereby validate that significantly more information about the molecular make-up of the tumor becomes available by introduction of up-front ctDNA. To establish that the number of tissue NGS analyses decreases and time to therapeutic decision making is shortened. To build and to validate, using ctDNA, TM and other information, multiparametric decision support models that may support diagnosis, predict the outcome of the next imaging procedure and survival during follow up. The final goal is to develop a super-resolution microscopy test that can detect PD-L1 expression on CTCs.
STUDY DESIGN: Multicenter, prospective, implementation and diagnostic cohort study.
STUDY POPULATION: 800 patients suspected of having lung cancer.
MAIN STUDY PARAMETERS/ENDPOINTS: ctDNA analysis, as additional source of genetic information, has been integrated into the diagnostic workup of LC patients and the medical benefits thereof are quantified, e.g. a significant higher percentage of patients with a driver mutation is identified by introduction of the plasma first approach. Multiparametric decision support algorithms based on imaging, TM and ctDNA analyses that identify small-cell LC (SCLC) and non-small-cell LC (NSCLC) have been developed and validated. Multiparametric decision support models have been developed that enable patient-specific timing of imaging procedures and predict survival during follow-up of LC patients. A super-resolution microscopy test for PD-L1 is developed and correlation with tumor tissue PD-L1 expression has been established.
NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT AND GROUP RELATEDNESS: At diagnosis, an extra 10 mL of blood are drawn during a routine venipuncture. Patients with advanced stage LC (stage IIIb/c or IV) undergo an extra venipuncture (40 mL).The longest follow up period for a patient is 36 months with a maximum of 20 blood draws. The volume per draw ranges from 10-40 mL. The risks of a venipuncture are negligible and the burden minimal. Those patients for whom a targetable mutation is found by ctDNA analysis benefit from the advantages of targeted therapy, i.e. better survival and less side effects of the treatment.
- Conditions
- Lung Cancer
- Keywords
- lungmarker2 study, lung cancer, liquid biopsy, ctDNA, CTCs, tumormarkers
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Up-front ctDNA analysis is implemented into routine clinical care in the participating OncoZoN hospitals
After the Lungmarker2 study has proven up-front ctDNA analysis to be feasible and successful for diagnosis and monitoring of lung cancer, hospitals participating in this project will adopt this as routine practice. Up-front ctDNA analysis will be adopted by the other OncoZON hospitals outside the consortium through transfer of the clinical practice during the regular tumor board meetings where shared care decisions are made for individual patients.
Measured: Up to 3 years
Evaluate the number of driver mutations detected by up-front ctDNA analysis compared to tumor NGS analysis
Determine and compare the number of driver mutations detected by up-front ctDNA analysis with the number of driver mutations detected by tumor NGS analysis.
Measured: Up to 3 years
Develop decision support algorithms for the diagnosis and monitoring of lung cancer patients
Develop decision support algorithms using information from CT scans, measured tumor markers (CA125, CA15.3, CEA, CYFRA 21.1, HE-4, NSE, proGRP, SCCA) and ctDNA analysis to identify small-cell lung cancer and non-small-cell lung cancer patients (classification, diagnosis).
Develop decision support algorithms to predict therapy response, expressed as a threshold for durable clinical benefit: the progression free survival (PFS) at 6 months (as probability %), in lung cancer patients (monitoring).
Different metrics regarding model performances will be reported: area under the receiver operating characteristic curve (AUC), area under the precision- recall curve (AUC-PR), sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV).
Measured: Up to 3 years
Secondary outcomes (2)
Develop an analytical protocol for the analysis of PD-L1 expression on circulating tumor cells (CTCs) by super-resolution microscopy
Develop an analytical protocol for the isolation of CTCs from whole blood samples (measured as the number of cells per mL) and to quantify PD-L1 expression (reported as a percentage on a scale of 0% to 100%) on the isolated CTCs using super-resolution microscopy.
Measured: Up to 3 years
Evaluate the number of tumor NGS analyses and time to diagnosis when up-front ctDNA analysis is introduced
Determine the time to diagnosis (in days) of lung cancer (e.g., time between first visit at lung physician and the diagnosis) when using up-front ctDNA analysis compared to tumor NGS analysis, and determine the number of tumor NGS analyses that can be replaced by up-front ctDNA analysis.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start31 Oct 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for 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
- 800 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Eindhoven University of Technology, Roche BV Netherlands, Maxima Medical Center, Zuyderland Medisch Centrum, Maastricht University Medical Center, St. Anna Ziekenhuis, Geldrop, Netherlands, The Netherlands Cancer Institute
- Responsible party
- Principal investigator, Volkher Scharnhorst, Catharina Ziekenhuis Eindhoven
- Investigators
- Volkher Scharnhorst, Prof.Dr., Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105177
- Sponsor's protocol ID
- NL83276.100.22
- Acronym
- LM2
- Status last verified
- Sep 2024
- First submitted
- 17 Oct 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ignatiadis M, Sledge GW, Jeffrey SS. Liquid biopsy enters the clinic - implementation issues and future challenges. Nat Rev Clin Oncol. 2021 May;18(5):297-312. doi: 10.1038/s41571-020-00457-x. Epub 2021 Jan 20.
PubMed 33473219IJzerman MJ, de Boer J, Azad A, Degeling K, Geoghegan J, Hewitt C, Hollande F, Lee B, To YH, Tothill RW, Wright G, Tie J, Dawson SJ. Towards Routine Implementation of Liquid Biopsies in Cancer Management: It Is Always Too Early, until Suddenly It Is Too Late. Diagnostics (Basel). 2021 Jan 11;11(1):103. doi: 10.3390/diagnostics11010103.
PubMed 33440749Rolfo C, Mack P, Scagliotti GV, Aggarwal C, Arcila ME, Barlesi F, Bivona T, Diehn M, Dive C, Dziadziuszko R, Leighl N, Malapelle U, Mok T, Peled N, Raez LE, Sequist L, Sholl L, Swanton C, Abbosh C, Tan D, Wakelee H, Wistuba I, Bunn R, Freeman-Daily J, Wynes M, Belani C, Mitsudomi T, Gandara D. Liquid Biopsy for Advanced NSCLC: A Consensus Statement From the International Association for the Study of Lung Cancer. J Thorac Oncol. 2021 Oct;16(10):1647-1662. doi: 10.1016/j.jtho.2021.06.017. Epub 2021 Jul 8.
PubMed 34246791de Kock R, Deiman B, Kraaijvanger R, Scharnhorst V. Optimized (Pre) Analytical Conditions and Workflow for Droplet Digital PCR Analysis of Cell-Free DNA from Patients with Suspected Lung Carcinoma. J Mol Diagn. 2019 Sep;21(5):895-902. doi: 10.1016/j.jmoldx.2019.05.003. Epub 2019 Jun 21.
PubMed 31229652Genet SAAM, Visser E, van den Borne BEEM, Soud MY, Belderbos HNA, Stege G, de Saegher MEA, Eduati F, Broeren MAC, van Dongen J, Brunsveld L, van de Kerkhof D, Scharnhorst V. Correction of the NSE concentration in hemolyzed serum samples improves its diagnostic accuracy in small-cell lung cancer. Oncotarget. 2020 Jul 7;11(27):2660-2668. doi: 10.18632/oncotarget.27664. eCollection 2020 Jul 7.
PubMed 32676167de Kock R, van den Borne B, Youssef-El Soud M, Belderbos H, Brunsveld L, Scharnhorst V, Deiman B. Therapy Monitoring of EGFR-Positive Non-Small-Cell Lung Cancer Patients Using ddPCR Multiplex Assays. J Mol Diagn. 2021 Apr;23(4):495-505. doi: 10.1016/j.jmoldx.2021.01.003. Epub 2021 Jan 22.
PubMed 33486072de Kock R, Knoops C, Baselmans M, Borne BVD, Brunsveld L, Scharnhorst V, Deiman B. Sensitive cell-free tumor DNA analysis in supernatant pleural effusions supports therapy selection and disease monitoring of lung cancer patients. Cancer Treat Res Commun. 2021;29:100449. doi: 10.1016/j.ctarc.2021.100449. Epub 2021 Aug 25.
PubMed 34481168de Kock R, Borne BVD, Soud MY, Belderbos H, Stege G, de Saegher M, van Dongen-Schrover C, Genet S, Brunsveld L, Scharnhorst V, Deiman B. Circulating biomarkers for monitoring therapy response and detection of disease progression in lung cancer patients. Cancer Treat Res Commun. 2021;28:100410. doi: 10.1016/j.ctarc.2021.100410. Epub 2021 Jun 1.
PubMed 34107412Visser E, de Kock R, Genet S, Borne BVD, Soud MY, Belderbos H, Stege G, de Saegher M, 't Westeinde SV, Broeren M, Eduati F, Deiman B, Scharnhorst V. Up-front mutation detection in circulating tumor DNA by droplet digital PCR has added diagnostic value in lung cancer. Transl Oncol. 2023 Jan;27:101589. doi: 10.1016/j.tranon.2022.101589. Epub 2022 Nov 19.
PubMed 36413862Visser E, Genet SAAM, de Kock RPPA, van den Borne BEEM, Youssef-El Soud M, Belderbos HNA, Stege G, de Saegher MEA, van 't Westeinde SC, Brunsveld L, Broeren MAC, van de Kerkhof D, Deiman BALM, Eduati F, Scharnhorst V. Liquid biopsy-based decision support algorithms for diagnosis and subtyping of lung cancer. Lung Cancer. 2023 Apr;178:28-36. doi: 10.1016/j.lungcan.2023.01.014. Epub 2023 Feb 1.
PubMed 36773458Hendriks LE, Kerr KM, Menis J, Mok TS, Nestle U, Passaro A, Peters S, Planchard D, Smit EF, Solomon BJ, Veronesi G, Reck M; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Apr;34(4):339-357. doi: 10.1016/j.annonc.2022.12.009. Epub 2023 Jan 23. No abstract available.
PubMed 36872130Hendriks LE, Kerr KM, Menis J, Mok TS, Nestle U, Passaro A, Peters S, Planchard D, Smit EF, Solomon BJ, Veronesi G, Reck M; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Non-oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Apr;34(4):358-376. doi: 10.1016/j.annonc.2022.12.013. Epub 2023 Jan 17. No abstract available.
PubMed 36669645Finall A, Davies G, Jones T, Emlyn G, Huey P, Mullard A. Integration of rapid PCR testing as an adjunct to NGS in diagnostic pathology services within the UK: evidence from a case series of non-squamous, non-small cell lung cancer (NSCLC) patients with follow-up. J Clin Pathol. 2023 Jun;76(6):391-399. doi: 10.1136/jclinpath-2021-207987. Epub 2022 Jan 18.
PubMed 35042754Thompson JC, Aggarwal C, Wong J, Nimgaonkar V, Hwang WT, Andronov M, Dibardino DM, Hutchinson CT, Ma KC, Lanfranco A, Moon E, Haas AR, Singh AP, Ciunci CA, Marmarelis M, D'Avella C, Cohen JV, Bauml JM, Cohen RB, Langer CJ, Vachani A, Carpenter EL. Plasma Genotyping at the Time of Diagnostic Tissue Biopsy Decreases Time-to-Treatment in Patients With Advanced NSCLC-Results From a Prospective Pilot Study. JTO Clin Res Rep. 2022 Mar 8;3(4):100301. doi: 10.1016/j.jtocrr.2022.100301. eCollection 2022 Apr.
PubMed 35392653Hendriks LEL, Dingemans AC, De Ruysscher DKM, Aarts MJ, Barberio L, Cornelissen R, Hartemink KJ, van den Heuvel M, Schuuring E, Smit HJM, van der Wekken AJ, Smit EF. Lung Cancer in the Netherlands. J Thorac Oncol. 2021 Mar;16(3):355-365. doi: 10.1016/j.jtho.2020.10.012. No abstract available.
PubMed 33641718
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Up-front ctDNA Analysis Into Lung Cancer Care and Development of Liquid Biopsy-based Decision Support Models - the Lungmarker² Study
- ClinicalTrials.gov ID
- NCT06105177
- Acronym / sponsor ID
- LM2 / NL83276.100.22
- Conditions
- Lung Cancer
- Keywords
- lungmarker2 study, lung cancer, liquid biopsy, ctDNA, CTCs, tumormarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Eindhoven University of Technology, Roche BV Netherlands, Maxima Medical Center, Zuyderland Medisch Centrum, Maastricht University Medical Center, St. Anna Ziekenhuis, Geldrop, Netherlands, The Netherlands Cancer Institute
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 27 Oct 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.
Despite scientific evidence, use of liquid biopsy (LB) in diagnosis and monitoring of lung cancer (LC) is limited since it requires major changes in diagnostic and care pathways. Analyzing tumor markers (TMs), circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in blood (LB) can inform about the nature of the tumor, the most appropriate therapy, therapy response and resistance.
Lungmarker2 is a multicenter, prospective, implementation and diagnostic cohort study. This study aims to implement up-front ctDNA analysis ('plasma first approach') into routine diagnostic work-up of all advanced stage LC patients in the Southeast of the Netherlands (the participating hospitals in the OncoZON region). Thereby, additional information about the molecular make-up of the tumor becomes available, the number of tissue Next-Generation Sequencing (NGS) analyses will decrease and time to therapeutic decision making is shortened. Next, using ctDNA, TM and other information, multi-parametric decision support models are built and validated that may support diagnosis, predict the outcome of the next imaging procedure and progression-free survival during follow-up. The final goal is to develop a super-resolution microscopy test that can detect PD-L1 expression on CTCs.
Detailed description
RATIONALE: Despite scientific evidence, use of liquid biopsy (LB) in diagnosis and monitoring of lung cancer (LC) is limited since it requires major changes in diagnostic and care pathways. Analyzing tumor markers (TMs), circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in blood (LB) can inform about the nature of the tumor, the most appropriate therapy, therapy response and resistance.
OBJECTIVE: To implement up-front ctDNA analysis ('plasma first approach') into routine diagnostic work-up of all advanced stage LC patients in the Southeast of the Netherlands (the participating hospitals in the OncoZON region) and to thereby validate that significantly more information about the molecular make-up of the tumor becomes available by introduction of up-front ctDNA. To establish that the number of tissue NGS analyses decreases and time to therapeutic decision making is shortened. To build and to validate, using ctDNA, TM and other information, multiparametric decision support models that may support diagnosis, predict the outcome of the next imaging procedure and survival during follow up. The final goal is to develop a super-resolution microscopy test that can detect PD-L1 expression on CTCs.
STUDY DESIGN: Multicenter, prospective, implementation and diagnostic cohort study.
STUDY POPULATION: 800 patients suspected of having lung cancer.
MAIN STUDY PARAMETERS/ENDPOINTS: ctDNA analysis, as additional source of genetic information, has been integrated into the diagnostic workup of LC patients and the medical benefits thereof are quantified, e.g. a significant higher percentage of patients with a driver mutation is identified by introduction of the plasma first approach. Multiparametric decision support algorithms based on imaging, TM and ctDNA analyses that identify small-cell LC (SCLC) and non-small-cell LC (NSCLC) have been developed and validated. Multiparametric decision support models have been developed that enable patient-specific timing of imaging procedures and predict survival during follow-up of LC patients. A super-resolution microscopy test for PD-L1 is developed and correlation with tumor tissue PD-L1 expression has been established.
NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT AND GROUP RELATEDNESS: At diagnosis, an extra 10 mL of blood are drawn during a routine venipuncture. Patients with advanced stage LC (stage IIIb/c or IV) undergo an extra venipuncture (40 mL).The longest follow up period for a patient is 36 months with a maximum of 20 blood draws. The volume per draw ranges from 10-40 mL. The risks of a venipuncture are negligible and the burden minimal. Those patients for whom a targetable mutation is found by ctDNA analysis benefit from the advantages of targeted therapy, i.e. better survival and less side effects of the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 800 individuals, >18 years of age, suspected of lung cancer and referred to a lung physician in one of the participating centers are included in the study.
Key inclusion criteria (1 listed)
- Aged 18 or above and suspected of having lung cancer
Key exclusion criteria (1 listed)
- Presence of another malignant tumor, i.e. diagnosed with a tumor in the past 5 years
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
Up-front ctDNA analysis is implemented into routine clinical care in the participating OncoZoN hospitals
Time frame: Up to 3 years
After the Lungmarker2 study has proven up-front ctDNA analysis to be feasible and successful for diagnosis and monitoring of lung cancer, hospitals participating in this project will adopt this as routine practice. Up-front ctDNA analysis will be adopted by the other OncoZON hospitals outside the consortium through transfer of the clinical practice during the regular tumor board meetings where shared care decisions are made for individual patients.
Evaluate the number of driver mutations detected by up-front ctDNA analysis compared to tumor NGS analysis
Time frame: Up to 3 years
Determine and compare the number of driver mutations detected by up-front ctDNA analysis with the number of driver mutations detected by tumor NGS analysis.
Develop decision support algorithms for the diagnosis and monitoring of lung cancer patients
Time frame: Up to 3 years
Develop decision support algorithms using information from CT scans, measured tumor markers (CA125, CA15.3, CEA, CYFRA 21.1, HE-4, NSE, proGRP, SCCA) and ctDNA analysis to identify small-cell lung cancer and non-small-cell lung cancer patients (classification, diagnosis). Develop decision support algorithms to predict therapy response, expressed as a threshold for durable clinical benefit: the progression free survival (PFS) at 6 months (as probability %), in lung cancer patients (monitoring). Different metrics regarding model performances will be reported: area under the receiver operating characteristic curve (AUC), area under the precision- recall curve (AUC-PR), sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV).
2 secondary outcomes
Develop an analytical protocol for the analysis of PD-L1 expression on circulating tumor cells (CTCs) by super-resolution microscopy
Time frame: Up to 3 years
Evaluate the number of tumor NGS analyses and time to diagnosis when up-front ctDNA analysis is introduced
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 33473219Ignatiadis M, Sledge GW, Jeffrey SS. Liquid biopsy enters the clinic - implementation issues and future challenges. Nat Rev Clin Oncol. 2021 May;18(5):297-312. doi: 10.1038/s41571-020-00457-x. Epub 2021 Jan 20.
- Background: PubMed 33440749IJzerman MJ, de Boer J, Azad A, Degeling K, Geoghegan J, Hewitt C, Hollande F, Lee B, To YH, Tothill RW, Wright G, Tie J, Dawson SJ. Towards Routine Implementation of Liquid Biopsies in Cancer Management: It Is Always Too Early, until Suddenly It Is Too Late. Diagnostics (Basel). 2021 Jan 11;11(1):103. doi: 10.3390/diagnostics11010103.
- Background: PubMed 34246791Rolfo C, Mack P, Scagliotti GV, Aggarwal C, Arcila ME, Barlesi F, Bivona T, Diehn M, Dive C, Dziadziuszko R, Leighl N, Malapelle U, Mok T, Peled N, Raez LE, Sequist L, Sholl L, Swanton C, Abbosh C, Tan D, Wakelee H, Wistuba I, Bunn R, Freeman-Daily J, Wynes M, Belani C, Mitsudomi T, Gandara D. Liquid Biopsy for Advanced NSCLC: A Consensus Statement From the International Association for the Study of Lung Cancer. J Thorac Oncol. 2021 Oct;16(10):1647-1662. doi: 10.1016/j.jtho.2021.06.017. Epub 2021 Jul 8.
- Background: PubMed 31229652de Kock R, Deiman B, Kraaijvanger R, Scharnhorst V. Optimized (Pre) Analytical Conditions and Workflow for Droplet Digital PCR Analysis of Cell-Free DNA from Patients with Suspected Lung Carcinoma. J Mol Diagn. 2019 Sep;21(5):895-902. doi: 10.1016/j.jmoldx.2019.05.003. Epub 2019 Jun 21.
- Background: PubMed 32676167Genet SAAM, Visser E, van den Borne BEEM, Soud MY, Belderbos HNA, Stege G, de Saegher MEA, Eduati F, Broeren MAC, van Dongen J, Brunsveld L, van de Kerkhof D, Scharnhorst V. Correction of the NSE concentration in hemolyzed serum samples improves its diagnostic accuracy in small-cell lung cancer. Oncotarget. 2020 Jul 7;11(27):2660-2668. doi: 10.18632/oncotarget.27664. eCollection 2020 Jul 7.
- Background: PubMed 33486072de Kock R, van den Borne B, Youssef-El Soud M, Belderbos H, Brunsveld L, Scharnhorst V, Deiman B. Therapy Monitoring of EGFR-Positive Non-Small-Cell Lung Cancer Patients Using ddPCR Multiplex Assays. J Mol Diagn. 2021 Apr;23(4):495-505. doi: 10.1016/j.jmoldx.2021.01.003. Epub 2021 Jan 22.
- Background: PubMed 34481168de Kock R, Knoops C, Baselmans M, Borne BVD, Brunsveld L, Scharnhorst V, Deiman B. Sensitive cell-free tumor DNA analysis in supernatant pleural effusions supports therapy selection and disease monitoring of lung cancer patients. Cancer Treat Res Commun. 2021;29:100449. doi: 10.1016/j.ctarc.2021.100449. Epub 2021 Aug 25.
- Background: PubMed 34107412de Kock R, Borne BVD, Soud MY, Belderbos H, Stege G, de Saegher M, van Dongen-Schrover C, Genet S, Brunsveld L, Scharnhorst V, Deiman B. Circulating biomarkers for monitoring therapy response and detection of disease progression in lung cancer patients. Cancer Treat Res Commun. 2021;28:100410. doi: 10.1016/j.ctarc.2021.100410. Epub 2021 Jun 1.
- Background: PubMed 36413862Visser E, de Kock R, Genet S, Borne BVD, Soud MY, Belderbos H, Stege G, de Saegher M, 't Westeinde SV, Broeren M, Eduati F, Deiman B, Scharnhorst V. Up-front mutation detection in circulating tumor DNA by droplet digital PCR has added diagnostic value in lung cancer. Transl Oncol. 2023 Jan;27:101589. doi: 10.1016/j.tranon.2022.101589. Epub 2022 Nov 19.
- Background: PubMed 36773458Visser E, Genet SAAM, de Kock RPPA, van den Borne BEEM, Youssef-El Soud M, Belderbos HNA, Stege G, de Saegher MEA, van 't Westeinde SC, Brunsveld L, Broeren MAC, van de Kerkhof D, Deiman BALM, Eduati F, Scharnhorst V. Liquid biopsy-based decision support algorithms for diagnosis and subtyping of lung cancer. Lung Cancer. 2023 Apr;178:28-36. doi: 10.1016/j.lungcan.2023.01.014. Epub 2023 Feb 1.
- Background: PubMed 36872130Hendriks LE, Kerr KM, Menis J, Mok TS, Nestle U, Passaro A, Peters S, Planchard D, Smit EF, Solomon BJ, Veronesi G, Reck M; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Apr;34(4):339-357. doi: 10.1016/j.annonc.2022.12.009. Epub 2023 Jan 23. No abstract available.
- Background: PubMed 36669645Hendriks LE, Kerr KM, Menis J, Mok TS, Nestle U, Passaro A, Peters S, Planchard D, Smit EF, Solomon BJ, Veronesi G, Reck M; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Non-oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Apr;34(4):358-376. doi: 10.1016/j.annonc.2022.12.013. Epub 2023 Jan 17. No abstract available.
- de Kock RPPAW. Tumor markers in diagnosis and therapy monitoring of lung cancer. Technische Universiteit Eindhoven; 2021.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Volkher Scharnhorst, Prof.Dr. principal investigator
Catharina Ziekenhuis Eindhoven
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Catharina Ziekenhuis Eindhoven at 5 sites in Netherlands.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Cao, MSc (+31402398644, hao.cao@catharinaziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Up-front ctDNA analysis is implemented into routine clinical care in the participating OncoZoN hospitals (time frame: Up to 3 years). 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 NCT06105177, which also lists 35 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 19 Sep 2024.