Breast CancerNCT01885039
Breast Tissue Study of Breast Diseases Among Women in Hong Kong
An observational study of Breast Cancer, run by National Cancer Institute (NCI) at 2 sites in China.
Trial summary
Background: The Chinese University of Hong Kong and the National Cancer Institute are conducting a breast tissue study in connection with another study on breast health. This larger study will look at breast health in women who live in Hong Kong. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- 12 Jun 2013to 31 Dec 2019
- 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 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female breast cancer patients identified from the Surgery or Oncology Departments of two hospitals in Hong Kong (North District Hospital and Yan Chai Hospital).
Who may be able to join
- Subjects who are participants in an ongoing breast cancer case-control study among Hong Kong women (Night shift and breast cancer: a case-control study among Hong Kong women, led by Dr. Tse at Chinese University in Hong Kong) and who will receive surgery at the North District Hospital, HK, age 18-100 years, inclusive.
Who cannot join
- Males, non-Asians, and children under 18 years will be excluded.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Characterization of Molecular Subtypes of Breast Cancer and Their Relationships With Known Breast Cancer Risk Factors Among Chinese Women in Hong Kong - A Pilot Study
Background:
- The Chinese University of Hong Kong and the National Cancer Institute are conducting a breast tissue study in connection with another study on breast health. This larger study will look at breast health in women who live in Hong Kong. Women in the breast health study will provide a breast tissue sample during biopsy surgery. Researchers want to use part of the sample to study changes in breast tissue that are related to breast diseases. This sample study is part of the larger study.
Read more
Objectives:
- To look at changes in breast tissue that are related to breast diseases.
Eligibility:
- Women who are participating in the Hong Kong breast health study.
- Participants must be having a biopsy to remove breast tissue for study.
Design:
- Participants will have a biopsy to remove a breast tissue sample. Most of the sample will be used for diagnosis. A portion of the leftover tissue will be used for this study.
- No extra surgery will be required.
- Treatment will not be provided as part of this study.
Read the detailed description
Background: Breast cancer incidence is increasing rapidly among many Asian populations primarily due to the adaptation of a Westernized lifestyle. However, Asian women seem to have a distinctive profile of breast cancer that differs from that seen in Western populations, such as earlier age at onset, more advanced stage, and higher frequency of ER-negative tumors. The disproportionally high rates among younger women were also seen among U.S.-born Asian women, such as Chinese, Filipina, Indian, and Pakistani women. These findings suggest that Asian breast cancer may have a distinct etiology that is not fully explained by adapting a westernized lifestyle. Recent molecular studies have suggested that breast cancers comprise several biologically and clinically distinct tumor subtypes. Epidemiologic evidence suggests that associations with breast cancer risk factors may vary by tumor subtype. However, most previous studies were conducted in Western populations; large, population-based epidemiologic studies characterizing molecular subtypes of breast cancer in Asian women are limited. In this study, we would like to characterize the molecular profile of breast cancer among Chinese women in Hong Kong and associate the molecular features with clinical and etiologic factors. An improved understanding of the inter-relationships among age, breast cancer subtypes, and race/ethnicity is critical for the development of targeted prevention and the best and most efficacious therapy.
Objectives: To assess the technical feasibility of 1) collecting fresh frozen tissues and fixed tissue blocks from breast cancer cases in Hong Kong, and 2) conducting tumor profiling analyses in the collected tissues.
Eligibility: Breast cancer cases who are participants in an ongoing breast cancer case control study among Hong Kong women (Night shift and breast cancer: a case-control study among Hong Kong women, led by Dr. Tse at Chinese University in Hong Kong) and who will receive surgery at the North District Hospital, HK, in 2013.
Design: In this feasibility study, we plan to collect fresh frozen and fixed tissues (tumor and adjacent normal) from approximately 100 breast cancer cases who have given consent to participate in our breast tissue collection pilot study. DNA and RNA will be extracted from frozen tumors and assessed for quality and yield. We will then conduct expression profiling analysis in a subset of cases (N approximately 10) to determine the quality of RNA in molecular profiling analysis. We will also determine whether there are enough epithelial benign and tumor tissues for the construction of tissue microarrays (TMAs). The results from this feasibility study will inform our decision on whether or not to pursue a large scale study.
- Conditions
- Breast Cancer
- Keywords
- Cancer, Breast Cancer, Molecular Subtypes, Asian Breast Cancer
- Medical subject headings
- Breast Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect fresh frozen breast tissues and 500 formalin-fixed parafin-embedded (FFPE) tissue blocks from 500 Hong Kong breast cancer cases
Breast Cancer
Measured: 12/31/2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study start12 Jun 2013
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Cancer Institute (NCI)The 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Rose Yang, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885039
- Sponsor's protocol ID
- 999913137
- Other IDs
- 13-C-N137
- Status last verified
- Mar 2020
- First submitted
- 20 Jun 2013
- Last updated
- 13 Mar 2020
- Results posted
- No
Publications
Sung H, Rosenberg PS, Chen WQ, Hartman M, Lim WY, Chia KS, Wai-Kong Mang O, Chiang CJ, Kang D, Ngan RK, Tse LA, Anderson WF, Yang XR. Female breast cancer incidence among Asian and Western populations: more similar than expected. J Natl Cancer Inst. 2015 Apr 13;107(7):djv107. doi: 10.1093/jnci/djv107. Print 2015 Jul.
PubMed 25868578Sung H, Rosenberg PS, Chen WQ, Hartman M, Lim WY, Chia KS, Wai-Kong Mang O, Tse L, Anderson WF, Yang XR. The impact of breast cancer-specific birth cohort effects among younger and older Chinese populations. Int J Cancer. 2016 Aug 1;139(3):527-34. doi: 10.1002/ijc.30095. Epub 2016 Apr 9.
PubMed 26992019Li M, Tse LA, Chan WC, Kwok CH, Leung SL, Wu C, Yu WC, Yu IT, Yu CH, Wang F, Sung H, Yang XR. Evaluation of breast cancer risk associated with tea consumption by menopausal and estrogen receptor status among Chinese women in Hong Kong. Cancer Epidemiol. 2016 Feb;40:73-8. doi: 10.1016/j.canep.2015.11.013. Epub 2015 Dec 8.
PubMed 26680603
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Molecular Subtypes of Breast Cancer and Their Relationships With Known Breast Cancer Risk Factors Among Chinese Women in Hong Kong - A Pilot Study
- ClinicalTrials.gov ID
- NCT01885039
- Acronym / sponsor ID
- 999913137
- Conditions
- Breast Cancer
- Keywords
- Cancer, Breast Cancer, Molecular Subtypes, Asian Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- Chinese University of Hong Kong
- Study start
- 12 Jun 2013 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Jun 2013 (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.
Background:
- The Chinese University of Hong Kong and the National Cancer Institute are conducting a breast tissue study in connection with another study on breast health. This larger study will look at breast health in women who live in Hong Kong. Women in the breast health study will provide a breast tissue sample during biopsy surgery. Researchers want to use part of the sample to study changes in breast tissue that are related to breast diseases. This sample study is part of the larger study.
Objectives:
- To look at changes in breast tissue that are related to breast diseases.
Eligibility:
- Women who are participating in the Hong Kong breast health study.
- Participants must be having a biopsy to remove breast tissue for study.
Design:
- Participants will have a biopsy to remove a breast tissue sample. Most of the sample will be used for diagnosis. A portion of the leftover tissue will be used for this study.
- No extra surgery will be required.
- Treatment will not be provided as part of this study.
Detailed description
Background: Breast cancer incidence is increasing rapidly among many Asian populations primarily due to the adaptation of a Westernized lifestyle. However, Asian women seem to have a distinctive profile of breast cancer that differs from that seen in Western populations, such as earlier age at onset, more advanced stage, and higher frequency of ER-negative tumors. The disproportionally high rates among younger women were also seen among U.S.-born Asian women, such as Chinese, Filipina, Indian, and Pakistani women. These findings suggest that Asian breast cancer may have a distinct etiology that is not fully explained by adapting a westernized lifestyle. Recent molecular studies have suggested that breast cancers comprise several biologically and clinically distinct tumor subtypes. Epidemiologic evidence suggests that associations with breast cancer risk factors may vary by tumor subtype. However, most previous studies were conducted in Western populations; large, population-based epidemiologic studies characterizing molecular subtypes of breast cancer in Asian women are limited. In this study, we would like to characterize the molecular profile of breast cancer among Chinese women in Hong Kong and associate the molecular features with clinical and etiologic factors. An improved understanding of the inter-relationships among age, breast cancer subtypes, and race/ethnicity is critical for the development of targeted prevention and the best and most efficacious therapy.
Objectives: To assess the technical feasibility of 1) collecting fresh frozen tissues and fixed tissue blocks from breast cancer cases in Hong Kong, and 2) conducting tumor profiling analyses in the collected tissues.
Eligibility: Breast cancer cases who are participants in an ongoing breast cancer case control study among Hong Kong women (Night shift and breast cancer: a case-control study among Hong Kong women, led by Dr. Tse at Chinese University in Hong Kong) and who will receive surgery at the North District Hospital, HK, in 2013.
Design: In this feasibility study, we plan to collect fresh frozen and fixed tissues (tumor and adjacent normal) from approximately 100 breast cancer cases who have given consent to participate in our breast tissue collection pilot study. DNA and RNA will be extracted from frozen tumors and assessed for quality and yield. We will then conduct expression profiling analysis in a subset of cases (N approximately 10) to determine the quality of RNA in molecular profiling analysis. We will also determine whether there are enough epithelial benign and tumor tissues for the construction of tissue microarrays (TMAs). The results from this feasibility study will inform our decision on whether or not to pursue a large scale study.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female breast cancer patients identified from the Surgery or Oncology Departments of two hospitals in Hong Kong (North District Hospital and Yan Chai Hospital).
Key inclusion criteria (1 listed)
- Subjects who are participants in an ongoing breast cancer case-control study among Hong Kong women (Night shift and breast cancer: a case-control study among Hong Kong women, led by Dr. Tse at Chinese University in Hong Kong) and who will receive surgery at the North District Hospital, HK, age 18-100 years, inclusive.
Key exclusion criteria (1 listed)
- Males, non-Asians, and children under 18 years will be excluded.
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
To collect fresh frozen breast tissues and 500 formalin-fixed parafin-embedded (FFPE) tissue blocks from 500 Hong Kong breast cancer cases
Time frame: 12/31/2018
Breast Cancer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Background: PubMed 25868578Sung H, Rosenberg PS, Chen WQ, Hartman M, Lim WY, Chia KS, Wai-Kong Mang O, Chiang CJ, Kang D, Ngan RK, Tse LA, Anderson WF, Yang XR. Female breast cancer incidence among Asian and Western populations: more similar than expected. J Natl Cancer Inst. 2015 Apr 13;107(7):djv107. doi: 10.1093/jnci/djv107. Print 2015 Jul.
- Background: PubMed 26992019Sung H, Rosenberg PS, Chen WQ, Hartman M, Lim WY, Chia KS, Wai-Kong Mang O, Tse L, Anderson WF, Yang XR. The impact of breast cancer-specific birth cohort effects among younger and older Chinese populations. Int J Cancer. 2016 Aug 1;139(3):527-34. doi: 10.1002/ijc.30095. Epub 2016 Apr 9.
- Background: PubMed 26680603Li M, Tse LA, Chan WC, Kwok CH, Leung SL, Wu C, Yu WC, Yu IT, Yu CH, Wang F, Sung H, Yang XR. Evaluation of breast cancer risk associated with tea consumption by menopausal and estrogen receptor status among Chinese women in Hong Kong. Cancer Epidemiol. 2016 Feb;40:73-8. doi: 10.1016/j.canep.2015.11.013. Epub 2015 Dec 8.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Rose Yang, Ph.D. principal investigator
National Cancer Institute (NCI)
2 sites 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 National Cancer Institute (NCI) at 2 sites in China.
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: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
To collect fresh frozen breast tissues and 500 formalin-fixed parafin-embedded (FFPE) tissue blocks from 500 Hong Kong breast cancer cases (time frame: 12/31/2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01885039, which also lists 3 linked publications.
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 13 Mar 2020.