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Circulating Fibrocytes in Non-small Cell Lung Cancer.

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ClinicalTrials.gov Identifier: NCT01998425
Recruitment Status : Unknown
Verified October 2013 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : November 28, 2013
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease
NSCLC

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : November 2013
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. treatment response of participants by RECIST. [ Time Frame: 18 months ]
    Correlation of circulating fibrocytes and treatment (chemotherapy, surgery, target treatment) response of patients with NSCLC.


Secondary Outcome Measures :
  1. Survival of participants. [ Time Frame: 24 months ]
    Correlation of circulating fibrocytes and survival (progression free survival, disease free survival and overall survival) of patients with NSCLC.


Other Outcome Measures:
  1. Staging status of patients with NSCLC. [ Time Frame: 18 months ]
    Correlation of circulating fibrocytes and stage of patients with NSCLC.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998425


Contacts
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Contact: Fu-Tsai Chung vikingchung@yahoo.com.tw

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Linkou, Taiwan
Contact: Fu-Tsai Chung       vikingchung@yahoo.com.tw   
Principal Investigator: Fu-Tsai Chung         
Sub-Investigator: Han-Pin Kuo         
Sub-Investigator: Chun-Hua Wang         
Sub-Investigator: Yueh-Fu Fang         
Sub-Investigator: Ting-Yu Lin         
Sub-Investigator: Chih-Teng Yu         
Chang Gung Memoral Hospital Recruiting
Taoyuan, Taiwan
Contact: Fu-Tsai Chung       vikingchung@yahoo.com.tw   
Principal Investigator: Fu-Tsai Chung         
Sub-Investigator: Meng-Heng Hsieh         
Sub-Investigator: Horng-Chyuan Lin         
Sub-Investigator: Chih-Hsi Kuo         
Sponsors and Collaborators
Chang Gung Memorial Hospital

Publications:

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01998425     History of Changes
Other Study ID Numbers: IRB100-2929B-FibLC-CGMH
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: October 2013

Keywords provided by Chang Gung Memorial Hospital:
circulating fibrocytes
fibrocyte
NSCLC
treatment response
survival
stage