Breast CancerNCT01287468
Academia Sinica Investigator Award 2010
An observational study of Breast Cancer, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Over the past five years, a spectrum of studies has shown that the stromal cell populations surrounding or embedding cancer cells in a variety of different tumor types are intrinsically involved in the mechanisms affecting tumor growth and metastasis. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 415 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2010to Dec 2014
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast Cancer patients
Who may be able to join
- adult
- breast cancer patient
- had signed the consent agreement, after your surgery, we will collect the sample from surgically removed breast tissue.
Who cannot join
- pregnancies
- minor children
- teenagers
- neonates
Trial locations and contacts
1 site in 1 country.
About this study
Over the past five years, a spectrum of studies has shown that the stromal cell populations surrounding or embedding cancer cells in a variety of different tumor types are intrinsically involved in the mechanisms affecting tumor growth and metastasis. Among these cells, fibroblasts and myeloid derived suppressor cells (MDSCs) have been shown to play key roles in the regulation of tumor cell behaviors, via differential gene expression, regulation and secretion of specific chemokines (e.g., RANTES, CXCL12 and CXCL14), cytokines (e.g., TNF-α, IL-1β, NF-κB) and control by inflammatory and immunomodulatory cells, molecules or potent growth factors. Of particular interest is that the various stromal immune cells (dendritic cells and T cells) and inflammatory MDSCs found in primary and metastatic tumors behave very differently from those present in normal or non-cancerous counterpart tissues. In light of these "new understandings" in cancer biology, the investigators believe that systematic and innovative approaches to further research are very much needed in Taiwan and at our Academy. Here the investigators propose to investigate the tumor suppressive effect of anti-inflammatory phytomedicines on regulation of stromal immune cells and fibroblasts in breast cancers. The investigators will employ the TS/A and 4T1 mouse mammary carcinoma system to conduct an in vivo study of several specific candidate phytomedicines (cytopiloyne, Wedelia chinensis, shikonin, emodin and others that the investigators have already identified as conferring anti-inflammation related activities) for inhibition of TS/A and 4T1 tumor growth and specific effects on inflammation-associated, cellular and molecular functions of stromal immune cells, fibroblasts and MDSCs. When potent and specific anti-tumor effects are detected, the investigators will extend our study to a three-dimensional collagen/Matrigel culture system for ex-vivo study focusing on the stromal cell-mediated or -associated anti-tumor effects of TS/A or 4T1 cells, using the "organoid" tissue culture systems the investigators have previously developed in our laboratory (JNCI, 1979; Cancer Res., 1981). The investigators will establish reconstituted TS/A or 4T1 tumor cells with the stromal immune cells in a co-cultivation system. When the investigators have achieved demonstrable success, the investigators will extend the mouse system to human breast cancers (including primary and metastatic tumors) by a close collaboration (which the investigators have already established) with Drs.
Read the detailed description
Ji-Hong Jhu (朱紀洪, Hospital President, M.D./surgeon) and Huey-Kong Sytwu (司徒惠康, M.D., Ph.D.) at the National Defense University Hospital. The investigators will then study the molecular signaling effect of specific phytocompounds already identified to confer in vivo (mouse), anti-tumor and anti-inflammatory activities, in primary/organoid cultures of human breast tumor cells under ex vivo conditions. Finally, the investigators intend to identify the key molecular regulators, immune-modulatory effectors of test stromal immune cells that are affected by the candidate phytomedicines, using molecular and cell biology assays to investigate the interplay between immune cells and tumor cells in the stromal tissues.
Our study is expected to reveal one or more highly specific, anti-inflammatory phytocompounds that mechanistically confer specific effects on stromal fibroblast or immune cell types, resulting in potent anti-tumor effects on test mammary carcinoma systems. Five Specific Aims are thus designed to investigate the immuno-modulating effects of specific medicinal constituents from TCM materials. The experimental findings obtained from this study would provide insights in the molecular, cellular and signaling mechanisms/effects of several medicinal phytocompounds that may have potential applications in chemoprevention or herbal medicine adjuvant treatment of human breast cancers.
- Conditions
- Breast Cancer
- Keywords
- phytomedicines, breast cancer, stromal fibroblasts, MDSCs, functional mechanism
- Medical subject headings
- Breast Neoplasms
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 |
|---|---|---|
| Experimental Group | Not described | |
| Control Group | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startJun 2010
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 415 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ning-Sun Yang, Principal investigator, Academia Sinica, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287468
- Sponsor's protocol ID
- 99052
- Status last verified
- Jan 2011
- First submitted
- 28 Jan 2011
- Last updated
- 1 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Academia Sinica Investigator Award 2010
- ClinicalTrials.gov ID
- NCT01287468
- Acronym / sponsor ID
- 99052
- Conditions
- Breast Cancer
- Keywords
- phytomedicines, breast cancer, stromal fibroblasts, MDSCs, functional mechanism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 415 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Study completion
- Dec 2014 (estimated)
- First posted
- 1 Feb 2011 (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.
Over the past five years, a spectrum of studies has shown that the stromal cell populations surrounding or embedding cancer cells in a variety of different tumor types are intrinsically involved in the mechanisms affecting tumor growth and metastasis. Among these cells, fibroblasts and myeloid derived suppressor cells (MDSCs) have been shown to play key roles in the regulation of tumor cell behaviors, via differential gene expression, regulation and secretion of specific chemokines (e.g., RANTES, CXCL12 and CXCL14), cytokines (e.g., TNF-α, IL-1β, NF-κB) and control by inflammatory and immunomodulatory cells, molecules or potent growth factors. Of particular interest is that the various stromal immune cells (dendritic cells and T cells) and inflammatory MDSCs found in primary and metastatic tumors behave very differently from those present in normal or non-cancerous counterpart tissues. In light of these "new understandings" in cancer biology, the investigators believe that systematic and innovative approaches to further research are very much needed in Taiwan and at our Academy. Here the investigators propose to investigate the tumor suppressive effect of anti-inflammatory phytomedicines on regulation of stromal immune cells and fibroblasts in breast cancers. The investigators will employ the TS/A and 4T1 mouse mammary carcinoma system to conduct an in vivo study of several specific candidate phytomedicines (cytopiloyne, Wedelia chinensis, shikonin, emodin and others that the investigators have already identified as conferring anti-inflammation related activities) for inhibition of TS/A and 4T1 tumor growth and specific effects on inflammation-associated, cellular and molecular functions of stromal immune cells, fibroblasts and MDSCs. When potent and specific anti-tumor effects are detected, the investigators will extend our study to a three-dimensional collagen/Matrigel culture system for ex-vivo study focusing on the stromal cell-mediated or -associated anti-tumor effects of TS/A or 4T1 cells, using the "organoid" tissue culture systems the investigators have previously developed in our laboratory (JNCI, 1979; Cancer Res., 1981). The investigators will establish reconstituted TS/A or 4T1 tumor cells with the stromal immune cells in a co-cultivation system. When the investigators have achieved demonstrable success, the investigators will extend the mouse system to human breast cancers (including primary and metastatic tumors) by a close collaboration (which the investigators have already established) with Drs.
Detailed description
Ji-Hong Jhu (朱紀洪, Hospital President, M.D./surgeon) and Huey-Kong Sytwu (司徒惠康, M.D., Ph.D.) at the National Defense University Hospital. The investigators will then study the molecular signaling effect of specific phytocompounds already identified to confer in vivo (mouse), anti-tumor and anti-inflammatory activities, in primary/organoid cultures of human breast tumor cells under ex vivo conditions. Finally, the investigators intend to identify the key molecular regulators, immune-modulatory effectors of test stromal immune cells that are affected by the candidate phytomedicines, using molecular and cell biology assays to investigate the interplay between immune cells and tumor cells in the stromal tissues.
Our study is expected to reveal one or more highly specific, anti-inflammatory phytocompounds that mechanistically confer specific effects on stromal fibroblast or immune cell types, resulting in potent anti-tumor effects on test mammary carcinoma systems. Five Specific Aims are thus designed to investigate the immuno-modulating effects of specific medicinal constituents from TCM materials. The experimental findings obtained from this study would provide insights in the molecular, cellular and signaling mechanisms/effects of several medicinal phytocompounds that may have potential applications in chemoprevention or herbal medicine adjuvant treatment of human breast cancers.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | – |
| Control Group | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast Cancer patients
Key inclusion criteria (3 listed)
- adult
- breast cancer patient
- had signed the consent agreement, after your surgery, we will collect the sample from surgically removed breast tissue.
Key exclusion criteria (4 listed)
- pregnancies
- minor children
- teenagers
- neonates
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2011.
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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.
Ning-Sun Yang principal investigator
Academia Sinica, Taiwan
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 Breast Cancer, run by Taipei Medical University WanFang 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 3 inclusion and 4 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 1 Feb 2011. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 1 Feb 2011.