Biomarker Study of Breast Tumors

NCT00941408 | Unknown

• 1 other identifier: BR03/17/08
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol aims to create a tissue bank of breast tumors obtained at the time of diagnosis for the identification of biomarkers for diagnosis, prognostication, and prediction of treatment response in breast cancer. While tissue banks now exist in major hospitals in Singapore to collect tumor specimens at the time of surgery, specimens collected at surgery from patients who had undergone pre-operative treatment represent a post-treatment sample and not a baseline, untreated sample. Such samples are intrinsically different from untreated samples, and have to be analyzed separately from untreated samples. However, they remain valuable samples, particularly if a pre-treatment sample has been obtained, providing paired pre- and post-treatment samples, which could provide valuable information on treatment-related tumor biomarker changes. A tissue bank comprising of samples collected during the diagnostic core biopsy thus represents a valuable supplement to existing tissue banks. Approximately 10-20% of patients diagnosed with non-metastatic breast cancer will require neoadjuvant chemotherapy. In addition, future clinical trials may include 'window-of-opportunity' studies during which biological therapy is administered for a short period (2-3 weeks) while an operable breast cancer patient is awaiting definitive surgery. The majority of early-stage breast cancer patients would be eligible for such trials, allowing the rapid recruitment of breast cancer patients. When coupled with analysis of surrogate markers of response (eg apoptosis, anti-angiogenic effects, etc), these unique clinical trials could provide valuable insights into the biological effects of new therapeutic agents in evaluation.

Conditions

Breast Tumors

Study Arms (1)

Diagnostic tumor core biopsy

Procedure: Diagnostic tumor core biopsy

Interventions

Diagnostic tumor core biopsy PROCEDURE

Diagnostic tumor core biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast lesions for whom a diagnostic core biopsy is planned

You may qualify if:

• Age \>= 18 years.
• Suspicious breast lesion for which diagnostic core biopsy is planned.
• Patients must not have received prior or scheduled to receive chemotherapy, hormonal therapy, radiotherapy, targeted therapy, or immunotherapy for the treatment of breast cancer.
• Signed informed consent from patient or legal representative.

You may not qualify if:

• Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

RECRUITING

Related Publications (2)

• Mouridsen HT, Andersen AP, Brincker H, Dombernowsky P, Rose C, Andersen KW. Adjuvant tamoxifen in postmenopausal high-risk breast cancer patients: present status of Danish Breast Cancer Cooperative Group trials. NCI Monogr. 1986;(1):115-8.

  PMID: 3534583 BACKGROUND

• Gaskell DJ, Hawkins RA, Sangsterl K, Chetty U, Forrest AP. Relation between immunocytochemical estimation of oestrogen receptor in elderly patients with primary breast cancer and response to tamoxifen. Lancet. 1989 May 13;1(8646):1044-6. doi: 10.1016/s0140-6736(89)92445-8.

  PMID: 2566000 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

During the diagnostic tumor core biopsy, 3-4 additional tumor samples will be obtained through the same needle track for the purpose of this study. The tumor cores will be stored in liquid nitrogen for subsequent histopathological analysis; DNA, RNA and protein will be extracted from tumor cores for genetic, gene expression and proteomics studies.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Soo Chin Lee, MBBS, MRCP

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo Chin Lee, MBBS, MRCP

CONTACT

65 6672 4629; Soo_Chin_Lee@nuhs.edu.sg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 17, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

SG (1)