Clinical Trial: Studying Blood and Tumor Tissue Samples in Women With Invasive Breast Cancer, Ductal or Lobular Carcinoma in Situ, or Benign Breast Disease

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Blood Tumor Markers for Molecular Diagnosis of Breast Diseases and Monitoring of Breast Cancer Treatment and Follow-up

Brief Summary:

RATIONALE: Collecting and storing samples of blood and tumor tissue from patients with cancer to test in the laboratory may help the study of cancer in the future.

PURPOSE: This clinical trial is studying blood and tumor tissue samples in women with invasive breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or benign breast disease.


Detailed Summary:

OBJECTIVES:

Primary

  • To establish a specimen bank from peripheral blood specimens collected from women with a full spectrum of breast disease (invasive breast cancer [IBC], ductal or lobular carcinoma in situ [CIS], or benign breast disease [BBD]) with standardized clinical follow up and serial specimen collection for those with IBC.
  • To determine the ability of quantitative real-time reverse-transcriptase PCR (qRT-PCR) to discriminate between patients with IBC, CIS, and BBD by comparing baseline assay values from pre-biopsy specimens to the histologic diagnosis.
  • To determine the ability of qRT-PCR to predict treatment response by comparing serial assay values from patients with evaluable IBC to their objective response.
  • To determine the ability of qRT-PCR to predict relapse by comparing the serial assay values from all patients with IBC to their disease status.
  • To determine the ability of qRT-PCR to perform as an independent prognostic factor by comparing baseline assay values from all patients with IBC to their disease status, stratified by known breast cancer prognostic factors.

Secondary

  • To perform exploratory studies identifying potential targets for novel nucleic acid and proteomic-based early detection assays.

OUTLINE: Patients undergo baseline peripheral blood specimen collection pre-biopsy and then periodically for up to 10 years. Specimens are analyzed for circulating tumor cells via quantitative real-time reverse-transcriptase PCR, immunofluorescence, a
Sponsor: City of Hope Medical Center

Current Primary Outcome:

  • Establishment of a specimen bank [ Time Frame: 5 Years of specimen collection ]
  • Ability of the quantitative real-time reverse-transcriptase PCR (qRT-PCR) to distinguish between biopsy benign and malignant results [ Time Frame: 5 years ]
  • Ability of the qRT-PCR to predict treatment response [ Time Frame: 5 years ]
  • Ability of the qRT-PCR to predict relapse [ Time Frame: 5 years ]
  • Ability of the qRT-PCR to perform as an independent prognostic factor [ Time Frame: 5 years ]


Original Primary Outcome:

  • Establishment of a specimen bank
  • Ability of the quantitative real-time reverse-transcriptase PCR (qRT-PCR) to distinguish between biopsy benign and malignant results
  • Ability of the qRT-PCR to predict treatment response
  • Ability of the qRT-PCR to predict relapse
  • Ability of the qRT-PCR to perform as an independent prognostic factor


Current Secondary Outcome:

Original Secondary Outcome:

Information By: City of Hope Medical Center

Dates:
Date Received: May 9, 2009
Date Started: August 2005
Date Completion:
Last Updated: December 7, 2016
Last Verified: December 2016