Circulating Fibrocytes in Non-small Cell Lung Cancer.

NSCLC Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01998425
• Other study ID #: IRB100-2929B-FibLC-CGMH
• Status: Recruiting
• Phase: N/A
• First received: November 13, 2013
• Last updated: July 29, 2015
• Start date: November 2013
• Est. completion date: July 2017

Study information

• Verified date: October 2013
• Source: Chang Gung Memorial Hospital
• Contact: Fu-Tsai Chung
• Email: vikingchung[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The investigators will collect fibrocytes (CD45+Col-1+) in patients with non-small cell lung cancer (NSCLC). The investigators hypothesize that patients with NSCLC experience expansion of immunosuppressive fibrocytes, which are predicted to augment tumor growth by mediating immune escape in NSCLC patients.

Description:

Fibrocytes have been described in both mice and humans, where they bear a hematopoietic progenitor phenotype (CD45+Col-1+). Fibrocytes have previously been described in murine cancer, implicated as mediators of tumor immune escape. In this study, the investigators will collect fibrocytes including CD45+Col-1+ expression. The cells express indoleamine oxidase, which is primarily responsible for their immunosuppressive properties. The investigators hypothesize that patients with non-small cell lung cancer experience expansion of immunosuppressive fibrocytes, which are predicted to augment tumor growth by mediating immune escape in non-small cell lung cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).

Exclusion Criteria:

• Combination of other malignancy.

• Age less than 20 years (not include 20 years).

• Pregnancy.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• NSCLC

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Linkou
Taiwan	Chang Gung Memoral Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

Chung FT, Lee KY, Wang CW, Heh CC, Chan YF, Chen HW, Kuo CH, Feng PH, Lin TY, Wang CH, Chou CL, Chen HC, Lin SM, Kuo HP. Tumor-associated macrophages correlate with response to epidermal growth factor receptor-tyrosine kinase inhibitors in advanced non-small cell lung cancer. Int J Cancer. 2012 Aug 1;131(3):E227-35. doi: 10.1002/ijc.27403. Epub 2012 Jan 11. — View Citation

Feng PH, Lee KY, Chang YL, Chan YF, Kuo LW, Lin TY, Chung FT, Kuo CS, Yu CT, Lin SM, Wang CH, Chou CL, Huang CD, Kuo HP. CD14(+)S100A9(+) monocytic myeloid-derived suppressor cells and their clinical relevance in non-small cell lung cancer. Am J Respir Crit Care Med. 2012 Nov 15;186(10):1025-36. doi: 10.1164/rccm.201204-0636OC. Epub 2012 Sep 6. — View Citation

Liu CY, Wang YM, Wang CL, Feng PH, Ko HW, Liu YH, Wu YC, Chu Y, Chung FT, Kuo CH, Lee KY, Lin SM, Lin HC, Wang CH, Yu CT, Kuo HP. Population alterations of L-arginase- and inducible nitric oxide synthase-expressed CD11b+/CD14?/CD15+/CD33+ myeloid-derived suppressor cells and CD8+ T lymphocytes in patients with advanced-stage non-small cell lung cancer. J Cancer Res Clin Oncol. 2010 Jan;136(1):35-45. doi: 10.1007/s00432-009-0634-0. — View Citation

Wang CH, Huang CD, Lin HC, Huang TT, Lee KY, Lo YL, Lin SM, Chung KF, Kuo HP. Increased activation of fibrocytes in patients with chronic obstructive asthma through an epidermal growth factor receptor-dependent pathway. J Allergy Clin Immunol. 2012 May;129(5):1367-76. doi: 10.1016/j.jaci.2012.01.038. Epub 2012 Feb 9. — View Citation

Wang CH, Huang CD, Lin HC, Lee KY, Lin SM, Liu CY, Huang KH, Ko YS, Chung KF, Kuo HP. Increased circulating fibrocytes in asthma with chronic airflow obstruction. Am J Respir Crit Care Med. 2008 Sep 15;178(6):583-91. doi: 10.1164/rccm.200710-1557OC. Epub 2008 Jun 26. — View Citation

Weng CM, Chen BC, Wang CH, Feng PH, Lee MJ, Huang CD, Kuo HP, Lin CH. The endothelin A receptor mediates fibrocyte differentiation in chronic obstructive asthma. The involvement of connective tissue growth factor. Am J Respir Crit Care Med. 2013 Aug 1;188(3):298-308. doi: 10.1164/rccm.201301-0132OC. — View Citation

Zhang H, Maric I, DiPrima MJ, Khan J, Orentas RJ, Kaplan RN, Mackall CL. Fibrocytes represent a novel MDSC subset circulating in patients with metastatic cancer. Blood. 2013 Aug 15;122(7):1105-13. doi: 10.1182/blood-2012-08-449413. Epub 2013 Jun 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Staging status of patients with NSCLC.	Correlation of circulating fibrocytes and stage of patients with NSCLC.	18 months	No
Primary	treatment response of participants by RECIST.	Correlation of circulating fibrocytes and treatment (chemotherapy, surgery, target treatment) response of patients with NSCLC.	18 months	No
Secondary	Survival of participants.	Correlation of circulating fibrocytes and survival (progression free survival, disease free survival and overall survival) of patients with NSCLC.	24 months	No