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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00898508
First received: May 9, 2009
Last updated: October 9, 2014
Last verified: October 2014

May 9, 2009
October 9, 2014
August 2005
November 2020   (final data collection date for primary outcome measure)
  • Establishment of a specimen bank [ Designated as safety issue: No ]
  • Ability of the quantitative real-time reverse-transcriptase PCR (qRT-PCR) to distinguish between biopsy benign and malignant results [ Designated as safety issue: No ]
  • Ability of the qRT-PCR to predict treatment response [ Designated as safety issue: No ]
  • Ability of the qRT-PCR to predict relapse [ Designated as safety issue: No ]
  • Ability of the qRT-PCR to perform as an independent prognostic factor [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00898508 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Studying Blood and Tumor Tissue Samples in Women With Invasive Breast Cancer, Ductal or Lobular Carcinoma in Situ, or Benign Breast Disease
Blood Tumor Markers for Molecular Diagnosis of Breast Diseases and Monitoring of Breast Cancer Treatment and Follow-up

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.

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, and bidirectional pyrophosphorolysis-activated polymerization allele-specific amplification; and for protein profiles via mass spectometry, liquid chromatography, enzyme digestion, and tandem mass spectometry. Patients' tumor tissue (invasive breast cancer [IBC] only) is analyzed for p53 via IHC. Medical records are reviewed periodically.

Patients with IBC complete a quality of life assessment at baseline and every 6 months for up to 10 years.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Peripheral blood sample and biopsy tissue

Probability Sample

City of Hope New patients

Breast Cancer
  • Genetic: gene expression analysis
  • Genetic: mutation analysis
  • Genetic: proteomic profiling
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: fluorescent antibody technique
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
  • Other: liquid chromatography
  • Other: mass spectrometry
  • Other: medical chart review
  • Procedure: quality-of-life assessment
  • Normal benign breast disease or ductal carcinoma in situ
    Interventions:
    • Genetic: gene expression analysis
    • Genetic: mutation analysis
    • Genetic: proteomic profiling
    • Genetic: reverse transcriptase-polymerase chain reaction
    • Other: fluorescent antibody technique
    • Other: immunohistochemistry staining method
    • Other: laboratory biomarker analysis
    • Other: liquid chromatography
    • Other: mass spectrometry
    • Other: medical chart review
    • Procedure: quality-of-life assessment
  • Invasive breast cancer
    Interventions:
    • Genetic: gene expression analysis
    • Genetic: mutation analysis
    • Genetic: proteomic profiling
    • Genetic: reverse transcriptase-polymerase chain reaction
    • Other: fluorescent antibody technique
    • Other: laboratory biomarker analysis
    • Other: liquid chromatography
    • Other: mass spectrometry
    • Other: medical chart review
    • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
910
Not Provided
November 2020   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Biopsy-confirmed diagnosis of one of the following:

    • Stage I-IV infiltrating ductal or infiltrating lobular carcinoma

      • Patients with early-stage disease must not have started systemic treatment; if no systemic treatment is planned, patients must be either preoperative or ≤ 120 days since definitive breast surgery
      • Patients with locally advanced disease must be scheduled for neoadjuvant chemotherapy prior to initiation of systemic treatment
    • Ductal carcinoma in situ
    • Lobular carcinoma in situ
    • Benign breast disease

      • Proliferative or non-proliferative
      • With or without atypia

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 50-100%
  • Not pregnant
  • No prior invasive cancer diagnosis within the past 5 years except for squamous cell or basal cell carcinoma of the skin

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior systemic therapy (chemotherapy or hormonal therapy) for patients with stage I-III disease
Female
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00898508
04125, P30CA033572, CHNMC-04125, CDR0000628766
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Melanie R. Palomares, MD, MS Beckman Research Institute
City of Hope Medical Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP