NSCLCNCT01998425
Circulating Fibrocytes in Non-small Cell Lung Cancer.
An observational study of NSCLC, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- NSCLC
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- Nov 2013to Jul 2017
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
Who cannot join
- Combination of other malignancy.
- Age less than 20 years (not include 20 years).
- Pregnancy.
Trial locations and contacts
2 sites in 1 country.
Fu-Tsai Chung contact
Taiwan2 sites, 2 recruiting
- Recruiting
Chang Gung Memorial Hospital
Linkou District
Fu-Tsai Chung, vikingchung@yahoo.com.tw
Fu-Tsai Chung
- Recruiting
Chang Gung Memoral Hospital
Taoyuan
Fu-Tsai Chung, vikingchung@yahoo.com.tw
Fu-Tsai Chung
About this study
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.
Read the 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.
- Conditions
- NSCLC
- Keywords
- circulating fibrocytes, fibrocyte, NSCLC, treatment response, survival, stage
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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment response of participants by RECIST.
Correlation of circulating fibrocytes and treatment (chemotherapy, surgery, target treatment) response of patients with NSCLC.
Measured: 18 months
Secondary outcomes (1)
Survival of participants.
Correlation of circulating fibrocytes and survival (progression free survival, disease free survival and overall survival) of patients with NSCLC.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998425
- Sponsor's protocol ID
- IRB100-2929B-FibLC-CGMH
- Status last verified
- Oct 2013
- First submitted
- 13 Nov 2013
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23795584Wang 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.
PubMed 22325070Wang 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.
PubMed 18583572Chung 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.
PubMed 22174092Zhang 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.
PubMed 23757729Feng 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.
PubMed 22955317Liu 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.
PubMed 19572148
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Fibrocytes in Non-small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT01998425
- Acronym / sponsor ID
- IRB100-2929B-FibLC-CGMH
- Conditions
- NSCLC
- Keywords
- circulating fibrocytes, fibrocyte, NSCLC, treatment response, survival, stage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 28 Nov 2013 (estimated)
- 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
Key exclusion criteria (3 listed)
- Combination of other malignancy.
- Age less than 20 years (not include 20 years).
- Pregnancy.
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
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.
1 secondary outcome
Survival of participants.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
- Background: PubMed 23795584Weng 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.
- Background: PubMed 22325070Wang 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.
- Background: PubMed 18583572Wang 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.
- Background: PubMed 22174092Chung 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.
- Background: PubMed 23757729Zhang 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.
- Background: PubMed 22955317Feng 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.
- Background: PubMed 19572148Liu 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.
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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.
Fu-Tsai Chung contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
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 1 inclusion and 3 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 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
Contact Fu-Tsai Chung (vikingchung@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment response of participants by RECIST. (time frame: 18 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 NCT01998425, which also lists 7 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 31 Jul 2015.