AgingPhase 1NCT00173251
The Difference in Presentation Level of Variant Receptors in Female Breast Tissue in Macromastia and Micromastia
A Phase 1 study testing obtain surgical specimen for analysis in people with Aging, run by National Taiwan University Hospital.
Trial summary
There are more and more macromastic women in Taiwan, which may due to the high cholesterol foods. Patients with macromastia not only suffered from physical problems but also psychological discomforts. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- obtain surgical specimen for analysis
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Aug 2006
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients receiving reduction mammoplasty
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
There are more and more macromastic women in Taiwan, which may due to the high cholesterol foods. Patients with macromastia not only suffered from physical problems but also psychological discomforts.
Read the detailed description
Large breasts cause neck and back pain, irritating grooves, cut in the skin of the shoulders by the pressure of brassiere straps, breast pain, and maceration and dermatoses in the inframammary region. From a psychological point of view, excessively large breasts can be troublesome focus of embarrassment for the teenager as well as the woman in her senior years. Unilateral hypertrophy with asymmetry heightens embarrassment. Thus, patients seek to reduce the size of their breasts.
In the human female, variant receptors were detected in epithelial cells in normal breast tissue, benign breast lesions, breast carcinoma tissue, and breast cancer cell lines2-11. The cause of the difference in breast development status is still unclear. Abnormalities at the tissue receptor level may be important in the pathophysiology of macromastia. This study aimed to make clear the difference in variant receptor levels between breast hypertrophy patients and macromastia ones by examining the receptor levels in breast tissue. Then, we could explore the possible etiology of mammary hypertrophy and macromastia.
- Conditions
- Aging
- Being tested
- obtain surgical specimen for analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obtain surgical specimen for analysisProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in receptor expression level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hao-Chih Tai, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173251
- Sponsor's protocol ID
- 9461700605
- Status last verified
- Jun 2005
- First submitted
- 12 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference in Presentation Level of Variant Receptors in Female Breast Tissue in Macromastia and Micromastia
- ClinicalTrials.gov ID
- NCT00173251
- Acronym / sponsor ID
- 9461700605
- Conditions
- Aging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Aug 2006
- First posted
- 15 Sep 2005 (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.
There are more and more macromastic women in Taiwan, which may due to the high cholesterol foods. Patients with macromastia not only suffered from physical problems but also psychological discomforts.
Detailed description
Large breasts cause neck and back pain, irritating grooves, cut in the skin of the shoulders by the pressure of brassiere straps, breast pain, and maceration and dermatoses in the inframammary region. From a psychological point of view, excessively large breasts can be troublesome focus of embarrassment for the teenager as well as the woman in her senior years. Unilateral hypertrophy with asymmetry heightens embarrassment. Thus, patients seek to reduce the size of their breasts.
In the human female, variant receptors were detected in epithelial cells in normal breast tissue, benign breast lesions, breast carcinoma tissue, and breast cancer cell lines2-11. The cause of the difference in breast development status is still unclear. Abnormalities at the tissue receptor level may be important in the pathophysiology of macromastia. This study aimed to make clear the difference in variant receptor levels between breast hypertrophy patients and macromastia ones by examining the receptor levels in breast tissue. Then, we could explore the possible etiology of mammary hypertrophy and macromastia.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients receiving reduction mammoplasty
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| obtain surgical specimen for analysis | Procedure or surgery | – |
Primary outcome
difference in receptor expression level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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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.
Hao-Chih Tai, M.D. principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing obtain surgical specimen for analysis in people with Aging, run by National Taiwan University Hospital.
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 15 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hao-Chih Tai, M.D. (886-2-23123456 ext. 5109, phoebe@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in receptor expression level. 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 15 Sep 2005.