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AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Taiwan1 site
  • Taipei Medical University - WanFang Hospital

    Taipei

Other trials in Taiwan

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 groups in NCT01287468
Study groupRoleWhat they receive
Experimental GroupNot described
Control GroupNot described

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2011 (estimated)
  2. Study startJun 2010
  3. Study completionDec 2014 (estimated)

Resources

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)
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

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.

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