Study of Circulating and Tumor Biomarkers in Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01866202|
Recruitment Status : Unknown
Verified December 2013 by National University Hospital, Singapore.
Recruitment status was: Recruiting
First Posted : May 31, 2013
Last Update Posted : December 11, 2013
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 or disease|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||February 2016|
- Detection of cancer specific antigens in blood and tumor tissue [ Time Frame: 1 year ]
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
|Contact: Soo Chin Lee, MBBS, MRCP||+65 6779 5555||Soo_Chin_Lee@nuhs.edu.sg|
|Nationa University Hospital||Recruiting|
|Contact: Soo Chin Lee, MBBS, MRCP +65 6779 5555 Soo_Chin_Lee@nuhs.edu.sg|
|Principal Investigator: Soo Chin Lee, MBBS, MRCP|