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Study of Circulating and Tumor Biomarkers in Breast Cancer Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01866202
First Posted: May 31, 2013
Last Update Posted: December 11, 2013
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.
Information provided by (Responsible Party):
National University Hospital, Singapore
  Purpose

Aims: To evaluate the role of monoclonal antibodies in the detection of cancer specific antigens in blood and tumor tissue, and the potential use of these antibodies for future evaluation for therapy. Also, to evaluate the presence of circulating tumor cells (CTCs) and to study EMT (epithelial-mesenchymal) signature changes during chemotherapy.

Methods: To take 20mls of blood from advanced breast cancer patients before a new course of anti-cancer therapy, and another 20mls of blood 3 weeks after treatment. In addition, Consent will be obtained to cut 10-15 tissue sections from their archival tumor specimens. Whenever possible, the blood taking will be timed such that no additional needle prick will be done specifically for the purpose of the study, by coinciding it with standard blood taking which is required for the patient's treatment.

Importance of proposed research to science or medicine:Detection of tumor specific antigens in the blood may potentially reduce the need for more invasive biopsies for confirmation of diagnosis of cancer or follow-up of cancer in the future. The identification and development of antibodies specific to these tumor antigens or markers may offer future therapeutic options, or as a vehicle to deliver cytotoxic therapy. Identification of CTCs as well as understanding the changes that occur in EMT signature in these circulating tumor cells may serve as a means of potential means of prognostication and modification of therapy in the future.

Potential Benefits and Risks: Potential risks to the patient include that of blood taking (pain, feeling faint, infection). Patients will not benefit directly from the study but the knowledge gained may help the management of future patients.

Cancer biomarkers, such as antigens and circulating tumor cells, may be a potential area to developing new methods of diagnosis and treatment of cancer. Monoclonal antibiotics are now able to be identified and isolated that may specifically target progenitors of breast cancer as well as CTCs. The changes that occur to CTCs during treatment may serve as a means of prognostication, as well as allow for therapeutic modifications. Clinical correlative studies into these areas (MAbs and CTCs) will serve to determine the role of these in clinical application in the future.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Detection of cancer specific antigens in blood and tumor tissue [ Time Frame: 1 year ]

Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
  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:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients being treated with Breast Cancer at National University Hospital (Singapore)
Criteria

Inclusion Criteria:

  • Advanced breast cancer patients whose cancer have progressed and are due to start a new course of anti-cancer therapy.The patient needs to have had previous breast cancer surgery at NUH (lumpectomy or mastectomy) or a diagnostic core biopsy for breast cancer, and consent to allow for blood taking and access to archival tissue.

Exclusion Criteria:

  • No available archival tumor specimen at NUH.
  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): NCT01866202


Contacts
Contact: Soo Chin Lee, MBBS, MRCP +65 6779 5555 Soo_Chin_Lee@nuhs.edu.sg

Locations
Singapore
Nationa University Hospital Recruiting
Singapore, Singapore
Contact: Soo Chin Lee, MBBS, MRCP    +65 6779 5555    Soo_Chin_Lee@nuhs.edu.sg   
Principal Investigator: Soo Chin Lee, MBBS, MRCP         
Sponsors and Collaborators
National University Hospital, Singapore
  More Information

Publications:
Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01866202     History of Changes
Other Study ID Numbers: 2012/00105
First Submitted: April 4, 2012
First Posted: May 31, 2013
Last Update Posted: December 11, 2013
Last Verified: December 2013

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