We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Breast Tissue Study of Breast Diseases Among Women in Hong Kong

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01885039
First Posted: June 24, 2013
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Chinese University of Hong Kong
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
  Purpose

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.

Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):

Primary Outcome Measures:
  • To assess technical feasibility of collecting fresh frozen breast tissues and formalin-fixed parafin-embedded (FFPE) tissue blocks from Hong Kong breast cancer cases [ Time Frame: 12/30/2018 ]

Estimated Enrollment: 500
Study Start Date: June 20, 2013
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

Males, non-Asians, and children under 18 years will be excluded.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885039


Locations
China
North District Hospital
Hong Kong, China
Yan Chai Hospital
Hong Kong, China
Sponsors and Collaborators
National Cancer Institute (NCI)
Chinese University of Hong Kong
Investigators
Principal Investigator: Rose Yang, Ph.D. National Cancer Institute (NCI)
  More Information

Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01885039     History of Changes
Other Study ID Numbers: 999913137
13-C-N137
First Submitted: June 20, 2013
First Posted: June 24, 2013
Last Update Posted: October 19, 2017
Last Verified: October 6, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Cancer
Breast Cancer
Molecular Subtypes
Asian Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases