Dynamic Monitoring Circulating Tumor DNA in Surgical Patients With Lung Cancer

NCT03317080 | Unknown DMC

• 1 other identifier: TSCI003
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lung Cancer

Keywords

lung cancer; circulating tumor DNA; molecular classification; dynamic monitoring; next generation sequencing; diagnosis; postoperative relapse

Outcome Measures

Primary Outcomes (1)

• recurrence-free survival

  from the date of surgery until the date of first verified recurrence or death from any cause

  up to 36 months

Secondary Outcomes (2)

• overall survival

  up to 36 months

• heterogeneity of lung cancer

  up to 36 months

Study Arms (1)

patients with lung cancer

patients with stages I-III lung cancer eligible for surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stage I-III lung cancer eligible for surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead
• GeneCast Biotechnology Co., Ltd.: collaborator
• Sichuan Provincial People's Hospital: collaborator

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (16)

• 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.

  PMID: 22752881 BACKGROUND

• Tsoi 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.

  PMID: 27913398 BACKGROUND

• Guo 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.

  PMID: 27913022 BACKGROUND

• Chansky 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.

  PMID: 19458556 BACKGROUND

• Perez-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.

  PMID: 27826533 BACKGROUND

• Groome 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.

  PMID: 17762335 BACKGROUND

• Su 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.

  PMID: 27652202 BACKGROUND

• Rolfo 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.

  PMID: 25444714 BACKGROUND

• Stroun 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.

  PMID: 11694251 BACKGROUND

• van 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.

  PMID: 18267930 BACKGROUND

• van 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.

  PMID: 18837919 BACKGROUND

• Torre 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.

  PMID: 25651787 BACKGROUND

• Schwarzenbach 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.

  PMID: 21562580 BACKGROUND

• Leon 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.

  PMID: 837366 BACKGROUND

• Ueda 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.

  PMID: 27556701 BACKGROUND

• Tie J, Wang Y, Tomasetti C, Li L, Springer S, Kinde I, Silliman N, Tacey M, Wong HL, Christie M, Kosmider S, Skinner I, Wong R, Steel M, Tran B, Desai J, Jones I, Haydon A, Hayes T, Price TJ, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016 Jul 6;8(346):346ra92. doi: 10.1126/scitranslmed.aaf6219.

  PMID: 27384348 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

tissue,blood and plasma

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lunxu Liu, M.D.,Ph.D.

  Department of Thoracic Surgery, West China Hospital, Sichuan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Department of Thoracic surgery

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 23, 2017
• Study Start: September 27, 2017
• Primary Completion: December 1, 2022
• Study Completion: September 1, 2023
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)