Lung CancerLUNGCANCT03317080
Dynamic Monitoring Circulating Tumor DNA in Surgical Patients With Lung Cancer
An observational study of Lung Cancer, run by West China Hospital at 1 site in China.
Trial summary
This study aims to promote the rational use of liquid biopsy in the clinical detection of lung cancer. Lung cancer is a malignant tumor with high morbidity and mortality worldwide. The incidence of lung cancer in China is expected to increase in the next few years with the aging population and environmental pollution. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2017to Sep 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with stage I-III lung cancer eligible for surgery.
Who may be able to join
- Patients with stage I-III lung cancer who are eligible for surgery(with no restriction of age, gender, or smoking history).
- ECOG score:0-1.
- Patients in the group will be allowed to collect whole blood or tissue samples at specific time points.
- Patients will be regularly tested according to the doctor's advice.
- Signed informed consent.
Who cannot join
- The tumor manifests as pure GGO on chest CT scan.
- Patients for surgical biopsy.
- Patients with serious mental disease.
- Surgery is contraindicated for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Value of Dynamic Monitoring Circulating Tumor DNA in Patients With Lung Cancer for Post-Operative Evaluation,Therapy Response Assessment,Relapse Prediction and Defining Molecular Phenotypes.
This study aims to promote the rational use of liquid biopsy in the clinical detection of lung cancer. Lung cancer is a malignant tumor with high morbidity and mortality worldwide. The incidence of lung cancer in China is expected to increase in the next few years with the aging population and environmental pollution. Early diagnosis and effective intervention are necessary in the clinical treatment of lung cancer. Surgical resection could achieve a better prognosis for patients with early lung cancer. However, for advanced lung cancer, individualized treatment based on the pathological classification, molecular genetic characteristics, and body conditions of patients could effectively prolong the lifetime. The prevention, diagnosis, and intervention strategies for lung cancer depend on the oncology information of patients. The techniques and methods used for detecting lung cancer in clinic include imaging technology, pathological biopsy, screening of blood tumor markers, and liquid biopsy technology, which has been developed recently. The liquid biopsy can capture the oncology information, including tumor load, tumor gene mutation, and so on, from the blood of patients with cancer by detecting circulating tumor cells, tumor exosome, circulating tumor DNA, and circulating tumor RNA. Moreover, it has become an important direction for clinical tumor detection because of its noninvasiveness, convenient sampling, and potential for overcoming tumor heterogeneity. This study intends to include 400 patients with stage I-III lung cancer to research on lung cancer diagnosis, drug efficacy, surgical effect evaluation, recurrence monitoring, prognosis judgment, medication guidance, and molecular classification differentiation through the dynamic detection of blood ctDNA using the second-generation sequencing technology. The study also intends to analyze and establish the database with a large sample size.
Read the detailed description
Lung cancer is a malignant tumor with high morbidity and mortality worldwide. The incidence and mortality of lung cancer in China have topped the list of malignant tumors since 2010.Early diagnosis and effective intervention are extremely important in the clinical treatment of lung cancer. Surgical resection could achieve better prognosis in patients with early lung cancer (stages IA and IB).For patients with advanced lung cancer (stages II, III, and IV), individualized treatment with molecular classification researches and the application of targeted drugs based on the pathological classification, molecular genetic characteristics, and body conditions of patients has been confirmed to effectively prolong the lifetime. However, the lack of effective and convenient detection approaches for capturing oncology information of patients, promoting early diagnosis and effective intervention of lung cancer, and ultimately improving the prognosis of lung cancer are limitations in achieving successful clinical treatment of lung cancer.
At present, methods used in clinical screening of lung cancer,including detection of serological markers, imaging technology, and biopsy ,have some limitations:in the absence of imaging evidence, the serological assessment could not be used as the evidence for diagnosis and treatment strategy alteration for lung cancer. The application of low-dose computed tomography scan for lung cancer screening shows a high false-positive rate, which is liable to require excessive medical treatment. Biopsy does greater harm to patients with lung cancer; sampling is difficult, and effective information may be missed because of tumor heterogeneity. With the development of molecular pathology in cancer research in recent years, liquid biopsy has become an important developmental direction for clinical tumor detection because of its noninvasiveness, convenient sampling, and potential for overcoming tumor heterogeneity.Liquid biopsies include the detection of circulating tumor cells (CTCs), tumor exosome (exosome), circulating tumor RNA (ctRNA), and circulating tumor DNA (ctDNA) in peripheral blood.
ctDNA is a part of circulating free DNA (cfDNA), which is released by tumor cell necrosis, apoptosis, micrometastasis, or the cleavage of CTCs and proliferated tumor cells.ctDNA includes genetic information of tumor cells, such as mutation, recombination, and deletion (15). ctDNA was approved by the European Medicines Agency in 2014 and the National Comprehensive Cancer Network Guidelines for NSCLC in 2017 as a supplement sample to assess genetic variation when tumor tissue samples were difficult to obtain. Clinical studies have shown that ctDNA can effectively reflect tumor load, malignant degree, metastasis ability, and real-time information of genetic mutation, which has a certain correlation with the genetic information of tumor tissues. Moreover, the content of cfDNA in patients with cancer was significantly higher than that in healthy people. Also, ctDNA has been used for detecting tumor load, monitoring tumor recurrence, and assessing minimal residual disease in a number of cancer types. Some studies have suggested that ctDNA can be used to estimate tumor recurrence, even before imaging. Therefore, ctDNA detection has an important value in the clinical application of lung cancer diagnosis, drug efficacy, surgical effect evaluation, recurrence monitoring, prognosis judgment, medication guidance, and molecular classification differentiation.
This study intends to include 400 patients with stage I-III lung cancer. The capture sequencing of lung cancer-related genes in peripheral blood ctDNA and tumor tissue DNA will be performed during the diagnosis and treatment process using the liquid-phase hybridization approach. Thus, the study will establish a large sample size database of the genetic variants in patients with lung cancer during the diagnosis and treatment process, and promoted the development of an individualized diagnostic model of the lung cancer population. The patients with lung cancer undergoing surgery will be followed up, and the plasma concentration of cfDNA and genetic mutation of ctDNA will be detected to evaluate the postoperative residual cancer, monitor tumor recurrence, and timely guide the clinical treatment and intervention. The molecular classification differentiation analysis and screening of tumor recurrence-related genetic mutations will be performed after the surgery and during the course of disease progression to provide the referential clinical research model and ideas for the application of ctDNA detection-based liquid biopsy technique in tumor therapy.
- Conditions
- Lung Cancer
- Keywords
- lung cancer, circulating tumor DNA, molecular classification, dynamic monitoring, next generation sequencing, diagnosis, postoperative relapse
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with lung cancer | patients with stages I-III lung cancer eligible for surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence-free survival
from the date of surgery until the date of first verified recurrence or death from any cause
Measured: up to 36 months
Secondary outcomes (2)
overall survival
from the date of surgery until the date of death from any cause
Measured: up to 36 months
heterogeneity of lung cancer
the relationship between heterogeneity of lung cancer and clinical results following surgery and adjuvant therapy
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start27 Sep 2017
- Primary completionDec 2022 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GeneCast Biotechnology Co., Ltd., Sichuan Provincial People's Hospital
- Responsible party
- Principal investigator, Lunxu Liu, West China Hospital
- Investigators
- Lunxu Liu, M.D.,Ph.D., Principal investigator, Department of Thoracic Surgery, West China Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317080
- Sponsor's protocol ID
- TSCI003
- Acronym
- LUNGCA
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2017
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bray F, Ren JS, Masuyer E, Ferlay J. Global estimates of cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013 Mar 1;132(5):1133-45. doi: 10.1002/ijc.27711. Epub 2012 Jul 26.
PubMed 22752881Tsoi KK, Hirai HW, Chan FC, Griffiths S, Sung JJ. Cancer burden with ageing population in urban regions in China: projection on cancer registry data from World Health Organization. Br Med Bull. 2017 Jan 1;121(1):83-94. doi: 10.1093/bmb/ldw050.
PubMed 27913398Guo Y, Zeng H, Zheng R, Li S, Pereira G, Liu Q, Chen W, Huxley R. The burden of lung cancer mortality attributable to fine particles in China. Sci Total Environ. 2017 Feb 1;579:1460-1466. doi: 10.1016/j.scitotenv.2016.11.147. Epub 2016 Nov 29.
PubMed 27913022Chansky K, Sculier JP, Crowley JJ, Giroux D, Van Meerbeeck J, Goldstraw P; International Staging Committee and Participating Institutions. The International Association for the Study of Lung Cancer Staging Project: prognostic factors and pathologic TNM stage in surgically managed non-small cell lung cancer. J Thorac Oncol. 2009 Jul;4(7):792-801. doi: 10.1097/JTO.0b013e3181a7716e.
PubMed 19458556Perez-Ramirez C, Canadas-Garre M, Robles AI, Molina MA, Faus-Dader MJ, Calleja-Hernandez MA. Liquid biopsy in early stage lung cancer. Transl Lung Cancer Res. 2016 Oct;5(5):517-524. doi: 10.21037/tlcr.2016.10.15.
PubMed 27826533Groome PA, Bolejack V, Crowley JJ, Kennedy C, Krasnik M, Sobin LH, Goldstraw P; IASLC International Staging Committee; Cancer Research and Biostatistics; Observers to the Committee; Participating Institutions. The IASLC Lung Cancer Staging Project: validation of the proposals for revision of the T, N, and M descriptors and consequent stage groupings in the forthcoming (seventh) edition of the TNM classification of malignant tumours. J Thorac Oncol. 2007 Aug;2(8):694-705. doi: 10.1097/JTO.0b013e31812d05d5.
PubMed 17762335Su C, Meyer M, Pirker R, Voigt W, Shi J, Pilz L, Huber RM, Wu Y, Wang J, He Y, Wang X, Zhang J, Zhi X, Shi M, Zhu B, Schoenberg SS, Henzler T, Manegold C, Zhou C, Roessner ED. From diagnosis to therapy in lung cancer: management of CT detected pulmonary nodules, a summary of the 2015 Chinese-German Lung Cancer Expert Panel. Transl Lung Cancer Res. 2016 Aug;5(4):377-88. doi: 10.21037/tlcr.2016.07.09.
PubMed 27652202Rolfo C, Castiglia M, Hong D, Alessandro R, Mertens I, Baggerman G, Zwaenepoel K, Gil-Bazo I, Passiglia F, Carreca AP, Taverna S, Vento R, Santini D, Peeters M, Russo A, Pauwels P. Liquid biopsies in lung cancer: the new ambrosia of researchers. Biochim Biophys Acta. 2014 Dec;1846(2):539-46. doi: 10.1016/j.bbcan.2014.10.001. Epub 2014 Oct 16.
PubMed 25444714Stroun M, Lyautey J, Lederrey C, Olson-Sand A, Anker P. About the possible origin and mechanism of circulating DNA apoptosis and active DNA release. Clin Chim Acta. 2001 Nov;313(1-2):139-42. doi: 10.1016/s0009-8981(01)00665-9.
PubMed 11694251van der Vaart M, Pretorius PJ. The origin of circulating free DNA. Clin Chem. 2007 Dec;53(12):2215. doi: 10.1373/clinchem.2007.092734. No abstract available.
PubMed 18267930van der Vaart M, Pretorius PJ. Circulating DNA. Its origin and fluctuation. Ann N Y Acad Sci. 2008 Aug;1137:18-26. doi: 10.1196/annals.1448.022.
PubMed 18837919Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
PubMed 25651787Schwarzenbach H, Hoon DS, Pantel K. Cell-free nucleic acids as biomarkers in cancer patients. Nat Rev Cancer. 2011 Jun;11(6):426-37. doi: 10.1038/nrc3066. Epub 2011 May 12.
PubMed 21562580Leon SA, Shapiro B, Sklaroff DM, Yaros MJ. Free DNA in the serum of cancer patients and the effect of therapy. Cancer Res. 1977 Mar;37(3):646-50.
PubMed 837366Ueda M, Iguchi T, Masuda T, Nakahara Y, Hirata H, Uchi R, Niida A, Momose K, Sakimura S, Chiba K, Eguchi H, Ito S, Sugimachi K, Yamasaki M, Suzuki Y, Miyano S, Doki Y, Mori M, Mimori K. Somatic mutations in plasma cell-free DNA are diagnostic markers for esophageal squamous cell carcinoma recurrence. Oncotarget. 2016 Sep 20;7(38):62280-62291. doi: 10.18632/oncotarget.11409.
PubMed 27556701
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Value of Dynamic Monitoring Circulating Tumor DNA in Patients With Lung Cancer for Post-Operative Evaluation,Therapy Response Assessment,Relapse Prediction and Defining Molecular Phenotypes.
- ClinicalTrials.gov ID
- NCT03317080
- Acronym / sponsor ID
- LUNGCA / TSCI003
- Conditions
- Lung Cancer
- Keywords
- lung cancer, circulating tumor DNA, molecular classification, dynamic monitoring, next generation sequencing, diagnosis, postoperative relapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- GeneCast Biotechnology Co., Ltd., Sichuan Provincial People's Hospital
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 23 Oct 2017 (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 study aims to promote the rational use of liquid biopsy in the clinical detection of lung cancer. Lung cancer is a malignant tumor with high morbidity and mortality worldwide. The incidence of lung cancer in China is expected to increase in the next few years with the aging population and environmental pollution. Early diagnosis and effective intervention are necessary in the clinical treatment of lung cancer. Surgical resection could achieve a better prognosis for patients with early lung cancer. However, for advanced lung cancer, individualized treatment based on the pathological classification, molecular genetic characteristics, and body conditions of patients could effectively prolong the lifetime. The prevention, diagnosis, and intervention strategies for lung cancer depend on the oncology information of patients. The techniques and methods used for detecting lung cancer in clinic include imaging technology, pathological biopsy, screening of blood tumor markers, and liquid biopsy technology, which has been developed recently. The liquid biopsy can capture the oncology information, including tumor load, tumor gene mutation, and so on, from the blood of patients with cancer by detecting circulating tumor cells, tumor exosome, circulating tumor DNA, and circulating tumor RNA. Moreover, it has become an important direction for clinical tumor detection because of its noninvasiveness, convenient sampling, and potential for overcoming tumor heterogeneity. This study intends to include 400 patients with stage I-III lung cancer to research on lung cancer diagnosis, drug efficacy, surgical effect evaluation, recurrence monitoring, prognosis judgment, medication guidance, and molecular classification differentiation through the dynamic detection of blood ctDNA using the second-generation sequencing technology. The study also intends to analyze and establish the database with a large sample size.
Detailed description
Lung cancer is a malignant tumor with high morbidity and mortality worldwide. The incidence and mortality of lung cancer in China have topped the list of malignant tumors since 2010.Early diagnosis and effective intervention are extremely important in the clinical treatment of lung cancer. Surgical resection could achieve better prognosis in patients with early lung cancer (stages IA and IB).For patients with advanced lung cancer (stages II, III, and IV), individualized treatment with molecular classification researches and the application of targeted drugs based on the pathological classification, molecular genetic characteristics, and body conditions of patients has been confirmed to effectively prolong the lifetime. However, the lack of effective and convenient detection approaches for capturing oncology information of patients, promoting early diagnosis and effective intervention of lung cancer, and ultimately improving the prognosis of lung cancer are limitations in achieving successful clinical treatment of lung cancer.
At present, methods used in clinical screening of lung cancer,including detection of serological markers, imaging technology, and biopsy ,have some limitations:in the absence of imaging evidence, the serological assessment could not be used as the evidence for diagnosis and treatment strategy alteration for lung cancer. The application of low-dose computed tomography scan for lung cancer screening shows a high false-positive rate, which is liable to require excessive medical treatment. Biopsy does greater harm to patients with lung cancer; sampling is difficult, and effective information may be missed because of tumor heterogeneity. With the development of molecular pathology in cancer research in recent years, liquid biopsy has become an important developmental direction for clinical tumor detection because of its noninvasiveness, convenient sampling, and potential for overcoming tumor heterogeneity.Liquid biopsies include the detection of circulating tumor cells (CTCs), tumor exosome (exosome), circulating tumor RNA (ctRNA), and circulating tumor DNA (ctDNA) in peripheral blood.
ctDNA is a part of circulating free DNA (cfDNA), which is released by tumor cell necrosis, apoptosis, micrometastasis, or the cleavage of CTCs and proliferated tumor cells.ctDNA includes genetic information of tumor cells, such as mutation, recombination, and deletion (15). ctDNA was approved by the European Medicines Agency in 2014 and the National Comprehensive Cancer Network Guidelines for NSCLC in 2017 as a supplement sample to assess genetic variation when tumor tissue samples were difficult to obtain. Clinical studies have shown that ctDNA can effectively reflect tumor load, malignant degree, metastasis ability, and real-time information of genetic mutation, which has a certain correlation with the genetic information of tumor tissues. Moreover, the content of cfDNA in patients with cancer was significantly higher than that in healthy people. Also, ctDNA has been used for detecting tumor load, monitoring tumor recurrence, and assessing minimal residual disease in a number of cancer types. Some studies have suggested that ctDNA can be used to estimate tumor recurrence, even before imaging. Therefore, ctDNA detection has an important value in the clinical application of lung cancer diagnosis, drug efficacy, surgical effect evaluation, recurrence monitoring, prognosis judgment, medication guidance, and molecular classification differentiation.
This study intends to include 400 patients with stage I-III lung cancer. The capture sequencing of lung cancer-related genes in peripheral blood ctDNA and tumor tissue DNA will be performed during the diagnosis and treatment process using the liquid-phase hybridization approach. Thus, the study will establish a large sample size database of the genetic variants in patients with lung cancer during the diagnosis and treatment process, and promoted the development of an individualized diagnostic model of the lung cancer population. The patients with lung cancer undergoing surgery will be followed up, and the plasma concentration of cfDNA and genetic mutation of ctDNA will be detected to evaluate the postoperative residual cancer, monitor tumor recurrence, and timely guide the clinical treatment and intervention. The molecular classification differentiation analysis and screening of tumor recurrence-related genetic mutations will be performed after the surgery and during the course of disease progression to provide the referential clinical research model and ideas for the application of ctDNA detection-based liquid biopsy technique in tumor therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with lung cancer | – | –patients with stages I-III lung cancer eligible for surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with stage I-III lung cancer eligible for surgery.
Key inclusion criteria (5 listed)
- Patients with stage I-III lung cancer who are eligible for surgery(with no restriction of age, gender, or smoking history).
- ECOG score:0-1.
- Patients in the group will be allowed to collect whole blood or tissue samples at specific time points.
- Patients will be regularly tested according to the doctor's advice.
- Signed informed consent.
Key exclusion criteria (4 listed)
- The tumor manifests as pure GGO on chest CT scan.
- Patients for surgical biopsy.
- Patients with serious mental disease.
- Surgery is contraindicated for any reason.
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
recurrence-free survival
Time frame: up to 36 months
from the date of surgery until the date of first verified recurrence or death from any cause
2 secondary outcomes
overall survival
Time frame: up to 36 months
heterogeneity of lung cancer
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Background: PubMed 22752881Bray F, Ren JS, Masuyer E, Ferlay J. Global estimates of cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013 Mar 1;132(5):1133-45. doi: 10.1002/ijc.27711. Epub 2012 Jul 26.
- Background: PubMed 27913398Tsoi KK, Hirai HW, Chan FC, Griffiths S, Sung JJ. Cancer burden with ageing population in urban regions in China: projection on cancer registry data from World Health Organization. Br Med Bull. 2017 Jan 1;121(1):83-94. doi: 10.1093/bmb/ldw050.
- Background: PubMed 27913022Guo Y, Zeng H, Zheng R, Li S, Pereira G, Liu Q, Chen W, Huxley R. The burden of lung cancer mortality attributable to fine particles in China. Sci Total Environ. 2017 Feb 1;579:1460-1466. doi: 10.1016/j.scitotenv.2016.11.147. Epub 2016 Nov 29.
- Background: PubMed 19458556Chansky K, Sculier JP, Crowley JJ, Giroux D, Van Meerbeeck J, Goldstraw P; International Staging Committee and Participating Institutions. The International Association for the Study of Lung Cancer Staging Project: prognostic factors and pathologic TNM stage in surgically managed non-small cell lung cancer. J Thorac Oncol. 2009 Jul;4(7):792-801. doi: 10.1097/JTO.0b013e3181a7716e.
- Background: PubMed 27826533Perez-Ramirez C, Canadas-Garre M, Robles AI, Molina MA, Faus-Dader MJ, Calleja-Hernandez MA. Liquid biopsy in early stage lung cancer. Transl Lung Cancer Res. 2016 Oct;5(5):517-524. doi: 10.21037/tlcr.2016.10.15.
- Background: PubMed 17762335Groome PA, Bolejack V, Crowley JJ, Kennedy C, Krasnik M, Sobin LH, Goldstraw P; IASLC International Staging Committee; Cancer Research and Biostatistics; Observers to the Committee; Participating Institutions. The IASLC Lung Cancer Staging Project: validation of the proposals for revision of the T, N, and M descriptors and consequent stage groupings in the forthcoming (seventh) edition of the TNM classification of malignant tumours. J Thorac Oncol. 2007 Aug;2(8):694-705. doi: 10.1097/JTO.0b013e31812d05d5.
- Background: PubMed 27652202Su C, Meyer M, Pirker R, Voigt W, Shi J, Pilz L, Huber RM, Wu Y, Wang J, He Y, Wang X, Zhang J, Zhi X, Shi M, Zhu B, Schoenberg SS, Henzler T, Manegold C, Zhou C, Roessner ED. From diagnosis to therapy in lung cancer: management of CT detected pulmonary nodules, a summary of the 2015 Chinese-German Lung Cancer Expert Panel. Transl Lung Cancer Res. 2016 Aug;5(4):377-88. doi: 10.21037/tlcr.2016.07.09.
- Background: PubMed 25444714Rolfo C, Castiglia M, Hong D, Alessandro R, Mertens I, Baggerman G, Zwaenepoel K, Gil-Bazo I, Passiglia F, Carreca AP, Taverna S, Vento R, Santini D, Peeters M, Russo A, Pauwels P. Liquid biopsies in lung cancer: the new ambrosia of researchers. Biochim Biophys Acta. 2014 Dec;1846(2):539-46. doi: 10.1016/j.bbcan.2014.10.001. Epub 2014 Oct 16.
- Background: PubMed 11694251Stroun M, Lyautey J, Lederrey C, Olson-Sand A, Anker P. About the possible origin and mechanism of circulating DNA apoptosis and active DNA release. Clin Chim Acta. 2001 Nov;313(1-2):139-42. doi: 10.1016/s0009-8981(01)00665-9.
- Background: PubMed 18267930van der Vaart M, Pretorius PJ. The origin of circulating free DNA. Clin Chem. 2007 Dec;53(12):2215. doi: 10.1373/clinchem.2007.092734. No abstract available.
- Background: PubMed 18837919van der Vaart M, Pretorius PJ. Circulating DNA. Its origin and fluctuation. Ann N Y Acad Sci. 2008 Aug;1137:18-26. doi: 10.1196/annals.1448.022.
- Background: PubMed 25651787Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
- Individual participant dataSharing planned: No
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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.
Lunxu Liu, M.D.,Ph.D. principal investigator
Department of Thoracic Surgery, West China Hospital, Sichuan University
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 Lung Cancer, run by West China Hospital at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 17 Oct 2022. 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 China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence-free survival (time frame: up to 36 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 NCT03317080, which also lists 16 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 Oct 2022.