NCT01998425

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 31, 2015

Status Verified

October 1, 2013

Enrollment Period

3.3 years

First QC Date

November 13, 2013

Last Update Submit

July 29, 2015

Conditions

NSCLC

Keywords

circulating fibrocytesfibrocyteNSCLCtreatment responsesurvivalstage

Outcome Measures

Primary Outcomes (1)

  • treatment response of participants by RECIST.

    Correlation of circulating fibrocytes and treatment (chemotherapy, surgery, target treatment) response of patients with NSCLC.

    18 months

Secondary Outcomes (1)

  • Survival of participants.

    24 months

Other Outcomes (1)

  • Staging status of patients with NSCLC.

    18 months

Study Arms (1)

Non-small cell lung cancer

The cohort data of patients with NSCLC will follow up from diagnosis, treatment response and final survival. Fibrocytes will be checked on the date of diagnsis (before treatment), re-staing (3months after treatment) and disease progression.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with histologically or cytologically confirmed non-small cell lung cancer (NSCLC) will be enrolled and evaluated from 2013 to 2016. Disease in all cases was staged with computed tomography (CT) of the chest, breast (if resectable) and positron emission tomography (PET, if resectable) within 3 months before enrollment.

You may qualify if:

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

You may not qualify if:

  • Combination of other malignancy.
  • Age less than 20 years (not include 20 years).
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chang Gung Memorial Hospital

Linkou District, Taiwan

RECRUITING

Chang Gung Memoral Hospital

Taoyuan District, Taiwan

RECRUITING

Related Publications (7)

  • 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.

    PMID: 23795584BACKGROUND

  • 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.

    PMID: 22325070BACKGROUND

  • 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.

    PMID: 18583572BACKGROUND

  • 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.

    PMID: 22174092BACKGROUND

  • 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.

    PMID: 23757729BACKGROUND

  • 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.

    PMID: 22955317BACKGROUND

  • 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.

    PMID: 19572148BACKGROUND

Central Study Contacts

Fu-Tsai Chung

CONTACT

vikingchung@yahoo.com.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2013

First Posted

November 28, 2013

Study Start

November 1, 2013

Primary Completion

February 1, 2017

Study Completion

July 1, 2017

Last Updated

July 31, 2015

Record last verified: 2013-10

Locations

TW(2)