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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

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.
 
ClinicalTrials.gov Identifier: NCT00898508
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : December 26, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

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.


Condition or disease Intervention/treatment
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

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 563 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Blood Tumor Markers for Molecular Diagnosis of Breast Diseases and Monitoring of Breast Cancer Treatment and Follow-up
Study Start Date : August 2005
Actual Primary Completion Date : June 6, 2019
Actual Study Completion Date : June 6, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Normal benign breast disease or ductal carcinoma in situ 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 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



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

Biospecimen Retention:   Samples With DNA
Peripheral blood sample and biopsy tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
City of Hope New patients
Criteria

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

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): NCT00898508


Locations
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United States, California
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
City of Hope Medical Group
Pasadena, California, United States, 91105
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Robert Hickey, Ph.D. City of Hope Comprehensive Cancer Center
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00898508    
Other Study ID Numbers: 04125
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-04125 ( Registry Identifier: NCI PDQ )
CDR0000628766 ( Registry Identifier: NCI )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2018
Keywords provided by City of Hope Medical Center:
invasive ductal breast carcinoma
invasive lobular breast carcinoma
ductal breast carcinoma in situ
lobular breast carcinoma in situ
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Carcinoma in Situ
Breast Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Skin Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs