TumorNCT00690261
The Impact of M1/M2 Tumor Associated Macrophage (TAM) Polarization on Cancer Progression and Prognosis Prediction
An observational study of Tumor and Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the correlation between M1/M2 phenotype of tumor associated macrophage (TAM) in lung cancer patients and clinical outcome. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tumor, Lung Cancer
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2007to Aug 2010
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients diagnosed of lung cancer with malignant pleural effusions
Who may be able to join
- lung cancer with malignant pleural effusions
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Ang Yuan, Ph.D. contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chao-Chi Ho, 886-2-2356-2905, ccho1203@ntu.edu.tw
About this study
The purpose of this study is to evaluate the correlation between M1/M2 phenotype of tumor associated macrophage (TAM) in lung cancer patients and clinical outcome.
Read the detailed description
Inflammatory response in the tumor micro-environment may facilitate the metastatic process (1). Macrophages are pivotal members of the inflammatory cells and the innate immune system within the tumor stroma. Tumor-associated macrophages can release growth factors, cytokines and inflammatory mediators that may facilitate cancer cell invasion, migration, angiogenesis, tumor progression or metastasis (1-5). A lot of studies showed TAM encounter factors that most frequently polarize them toward M2 type macrophage (1,4-5). It is interesting that in vitro studies macrophages have the potential to kill tumor by appropriate stimulation but these macrophage belonged to M1 and were not present in most tumor tissue (6). Some drugs target to suppress TAM have the promising results in animal models (7-9). Switching the TAM phenotype from M2 to M1 may promote anti-tumor activity (10). In this study we will correlate TAM M1/M2 ratio and patients' prognosis, the gene expression pattern of TAM.
References
- Coussens LM, Werb Z. Inflammation and cancer. Nature 2002;420(6917):860-867.
- Crowther M, Brown NJ, Bishop ET, Lewis CE. Microenvironmental influence on macrophage regulation of angiogenesis in wounds and malignant tumors. J Leukoc Biol 2001;70(4):478-490.
- Lin EY, Nguyen AV, Russell RG, Pollard JW. Colony-stimulating Factor 1 Promotes Progression of Mammary Tumors to Malignancy. J. Exp. Med. 2001;193(6):727-740.
- Mantovani A. Cancer Inflammation by remote control. Nature 2005;435(7043):752-753.
- Pollard JW. Tumor-educated macrophages promote tumour progression and metastasis. Nature Reviews Cancer 2004;4(1):71-78.
- Sica A, Schippa T, Mantovani A, Allavena P. Tumor-associated macrophage are distinct M2 polarized population promoting tumor progression: potential targets of anti-tumor therapy. Eur J of Cancer 2006;42:717-27
- Sessa C, De Braud F, Perotti A, et al. Trabectedin for women with ovarian carcinoma after treatment with platinum and taxanes fails. J Clin Oncol 2005;23:1867-74.
- Wahl L, Kleinman HK. Tumor-associated macrophages as targets for cancer therapy. J Natl Cancer Inst 1998;90:1583-4.
- Giraudo E, Inoue M, Hanahan D. An amino-bisphosphonate targets MMP-9-expressing macrophages and angiogenesis to impair cervical carcinogenesis. J Clin Invest 2004;114:623-33.
- Guiducci C, Vicari AP, Sangaletti S, Trinchieri G, Colombo MP. Redirecting in vivo elicited tumor infiltrating macrophages and dendritic cells towards tumor rejection. Cancer Res 2005;65:3437-46.
- Conditions
- Tumor, Lung Cancer
- Keywords
- tumor associated macrophage, lung cancer, outcome
- Medical subject headings
- Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
Also called No intervention in this study
No intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| lung cancer | patients diagnosed of lung cancer with malignant pleural effusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
outcome (treatment response and mortality)
Measured: 3 years
Secondary outcomes (1)
clinical presentation
Measured: at enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startSep 2007
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Chao-Chi Ho, Principal investigator, Department of Internal Medicine and Emergency Medicine, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690261
- Sponsor's protocol ID
- 200709004R
- Status last verified
- May 2008
- First submitted
- 1 Jun 2008
- Last updated
- 4 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of M1/M2 Tumor Associated Macrophage (TAM) Polarization on Cancer Progression and Prognosis Prediction
- ClinicalTrials.gov ID
- NCT00690261
- Acronym / sponsor ID
- 200709004R
- Conditions
- Tumor, Lung Cancer
- Keywords
- tumor associated macrophage, lung cancer, outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Sep 2007
- Study completion
- Aug 2010 (estimated)
- First posted
- 4 Jun 2008 (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 purpose of this study is to evaluate the correlation between M1/M2 phenotype of tumor associated macrophage (TAM) in lung cancer patients and clinical outcome.
Detailed description
Inflammatory response in the tumor micro-environment may facilitate the metastatic process (1). Macrophages are pivotal members of the inflammatory cells and the innate immune system within the tumor stroma. Tumor-associated macrophages can release growth factors, cytokines and inflammatory mediators that may facilitate cancer cell invasion, migration, angiogenesis, tumor progression or metastasis (1-5). A lot of studies showed TAM encounter factors that most frequently polarize them toward M2 type macrophage (1,4-5). It is interesting that in vitro studies macrophages have the potential to kill tumor by appropriate stimulation but these macrophage belonged to M1 and were not present in most tumor tissue (6). Some drugs target to suppress TAM have the promising results in animal models (7-9). Switching the TAM phenotype from M2 to M1 may promote anti-tumor activity (10). In this study we will correlate TAM M1/M2 ratio and patients' prognosis, the gene expression pattern of TAM.
References
- Coussens LM, Werb Z. Inflammation and cancer. Nature 2002;420(6917):860-867.
- Crowther M, Brown NJ, Bishop ET, Lewis CE. Microenvironmental influence on macrophage regulation of angiogenesis in wounds and malignant tumors. J Leukoc Biol 2001;70(4):478-490.
- Lin EY, Nguyen AV, Russell RG, Pollard JW. Colony-stimulating Factor 1 Promotes Progression of Mammary Tumors to Malignancy. J. Exp. Med. 2001;193(6):727-740.
- Mantovani A. Cancer Inflammation by remote control. Nature 2005;435(7043):752-753.
- Pollard JW. Tumor-educated macrophages promote tumour progression and metastasis. Nature Reviews Cancer 2004;4(1):71-78.
- Sica A, Schippa T, Mantovani A, Allavena P. Tumor-associated macrophage are distinct M2 polarized population promoting tumor progression: potential targets of anti-tumor therapy. Eur J of Cancer 2006;42:717-27
- Sessa C, De Braud F, Perotti A, et al. Trabectedin for women with ovarian carcinoma after treatment with platinum and taxanes fails. J Clin Oncol 2005;23:1867-74.
- Wahl L, Kleinman HK. Tumor-associated macrophages as targets for cancer therapy. J Natl Cancer Inst 1998;90:1583-4.
- Giraudo E, Inoue M, Hanahan D. An amino-bisphosphonate targets MMP-9-expressing macrophages and angiogenesis to impair cervical carcinogenesis. J Clin Invest 2004;114:623-33.
- Guiducci C, Vicari AP, Sangaletti S, Trinchieri G, Colombo MP. Redirecting in vivo elicited tumor infiltrating macrophages and dendritic cells towards tumor rejection. Cancer Res 2005;65:3437-46.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung cancer | – | –patients diagnosed of lung cancer with malignant pleural effusions |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed of lung cancer with malignant pleural effusions
Key inclusion criteria (1 listed)
- lung cancer with malignant pleural effusions
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Also: No intervention in this studyNo intervention in this study | Other | lung cancer |
Primary outcome
outcome (treatment response and mortality)
Time frame: 3 years
1 secondary outcome
clinical presentation
Time frame: at enrollement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2008.
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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.
Ang Yuan, Ph.D. contact
Chao-Chi Ho principal investigator
Department of Internal Medicine and Emergency Medicine, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor and Lung Cancer, run by National Taiwan University Hospital at 1 site 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 1 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 4 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Chao-Chi Ho, Ph.D. (886-2-2356-2905, ccho1203@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
outcome (treatment response and mortality) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2008.