NCT01885039

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

6.6 years

First QC Date

June 20, 2013

Last Update Submit

March 12, 2020

Conditions

Breast Cancer

Keywords

CancerBreast CancerMolecular SubtypesAsian Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • To collect fresh frozen breast tissues and 500 formalin-fixed parafin-embedded (FFPE) tissue blocks from 500 Hong Kong breast cancer cases

    Breast Cancer

    12/31/2018

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North District Hospital

Hong Kong, China

Location

Yan Chai Hospital

Hong Kong, China

Location

Related Publications (3)

  • 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.

    PMID: 25868578BACKGROUND

  • Sung 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.

    PMID: 26992019BACKGROUND

  • Li 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.

    PMID: 26680603BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens: Fresh frozen and fixed tissues (breast tumor and adjacent normal tissue)

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Rose Yang, Ph.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2013

First Posted

June 24, 2013

Study Start

June 12, 2013

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 13, 2020

Record last verified: 2020-03

Locations

CN(2)