Breast CancerNCT00155038
Imaging Characteristics of Breast Cancer in Women Under 40 Years of Age
An observational study of Breast Cancer and Breast Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To evaluate if there is any imaging characteristic of breast cancers in women younger than 40 years of age. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- How many people
- 75 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 1998to Dec 2005
- 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 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 20-39 years women with breast cancers
Who cannot join
- pregnant women
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Jane Wang, MD, 886-2-23123456 ext. 5565, hstjen@yahoo.com.tw
Jane Wang, MD
About this study
To evaluate if there is any imaging characteristic of breast cancers in women younger than 40 years of age.
Read the detailed description
In Western countries, breast cancer is the most commonly diagnosed cancer in women and breast cancer screening using mammography has reduced breast cancer mortality by 18-29%. In Taiwan, breast cancer is the second most common cancer in women and the Bureau of Health Promotion, Department of Health has started breast cancer screening using mammography in women between 50 and 69 years old since 2002, between 40 and 49 years old since early 2004. However, young women at 20 to 39 years of age have never been enrolled in the mass screening mammography program because of their relatively young age and mammographic findings of breast cancer in young women were seldom reported.Some authors found out that breast cancer in young women is more advanced and more often presents with a mass, has higher grade, more extensively proliferating and vessel invading disease when compared with those in older age groups. Most intraductal carcinomas (>80%) present as clustered microcalcifications on mammograms, and the sensitivity of mammography can be reduced in younger, denser breasts. Given these, mammography seems not to be a proper diagnostic tool for breast cancer women at a younger age. However, this presumption needs to be clarified since there are neither definite documented facts regarding breast cancer manifestation of young women on mammograms, nor documented sensitivity and false-negative rate of mammography in detecting of breast cancer among young women, at whom mammography is seldom used to be a diagnostic imaging tool. Our study is conducted to analyze the mammographic findings of breast cancers in young women between 20 and 39 years of age, regarding tumor size, location, major finding type, pathology type and grade. We will compare all of the above issues between younger age group and older age groups (40 to 49 and 50 to 69 years old).The breast ultrasound findings of the breast cancer among young women will be also compared with their corresponding mammographic findings, regarding the sensitivity, specificity, false-negative rate and accuracy.
- Conditions
- Breast Cancer, Breast Neoplasms
- Keywords
- Breast neoplasms, breast radiography, young women.
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 1998
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Defined population
- Time perspective
- Other
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jane Wang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155038
- Sponsor's protocol ID
- 9361700630
- Status last verified
- May 2004
- First submitted
- 9 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Publications
Colleoni M, Rotmensz N, Robertson C, Orlando L, Viale G, Renne G, Luini A, Veronesi P, Intra M, Orecchia R, Catalano G, Galimberti V, Nole F, Martinelli G, Goldhirsch A. Very young women (<35 years) with operable breast cancer: features of disease at presentation. Ann Oncol. 2002 Feb;13(2):273-9. doi: 10.1093/annonc/mdf039.
PubMed 11886005
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Characteristics of Breast Cancer in Women Under 40 Years of Age
- ClinicalTrials.gov ID
- NCT00155038
- Acronym / sponsor ID
- 9361700630
- Conditions
- Breast Cancer, Breast Neoplasms
- Keywords
- Breast neoplasms, breast radiography, young women.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 1998
- Study completion
- Dec 2005
- First posted
- 12 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.
To evaluate if there is any imaging characteristic of breast cancers in women younger than 40 years of age.
Detailed description
In Western countries, breast cancer is the most commonly diagnosed cancer in women and breast cancer screening using mammography has reduced breast cancer mortality by 18-29%. In Taiwan, breast cancer is the second most common cancer in women and the Bureau of Health Promotion, Department of Health has started breast cancer screening using mammography in women between 50 and 69 years old since 2002, between 40 and 49 years old since early 2004. However, young women at 20 to 39 years of age have never been enrolled in the mass screening mammography program because of their relatively young age and mammographic findings of breast cancer in young women were seldom reported.Some authors found out that breast cancer in young women is more advanced and more often presents with a mass, has higher grade, more extensively proliferating and vessel invading disease when compared with those in older age groups. Most intraductal carcinomas (>80%) present as clustered microcalcifications on mammograms, and the sensitivity of mammography can be reduced in younger, denser breasts. Given these, mammography seems not to be a proper diagnostic tool for breast cancer women at a younger age. However, this presumption needs to be clarified since there are neither definite documented facts regarding breast cancer manifestation of young women on mammograms, nor documented sensitivity and false-negative rate of mammography in detecting of breast cancer among young women, at whom mammography is seldom used to be a diagnostic imaging tool. Our study is conducted to analyze the mammographic findings of breast cancers in young women between 20 and 39 years of age, regarding tumor size, location, major finding type, pathology type and grade. We will compare all of the above issues between younger age group and older age groups (40 to 49 and 50 to 69 years old).The breast ultrasound findings of the breast cancer among young women will be also compared with their corresponding mammographic findings, regarding the sensitivity, specificity, false-negative rate and accuracy.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 20-39 years women with breast cancers
Key exclusion criteria (1 listed)
- pregnant women
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 12 Sep 2005.
- Results publication: PubMed 11886005Colleoni M, Rotmensz N, Robertson C, Orlando L, Viale G, Renne G, Luini A, Veronesi P, Intra M, Orecchia R, Catalano G, Galimberti V, Nole F, Martinelli G, Goldhirsch A. Very young women (<35 years) with operable breast cancer: features of disease at presentation. Ann Oncol. 2002 Feb;13(2):273-9. doi: 10.1093/annonc/mdf039.
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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.
Jane Wang, MD principal investigator
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 Breast Cancer and Breast Neoplasms, 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 12 Sep 2005. 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 Jane Wang, MD (886-2-23123456 ext. 5565, hstjen@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00155038, which also lists 1 linked publication.
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 12 Sep 2005.