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, 2013
Last verified: October 2013
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Peripheral blood sample and biopsy tissue


Estimated Enrollment: 910
Study Start Date: August 2005
Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898508

Locations
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
Investigators
Principal Investigator: Melanie R. Palomares, MD, MS Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00898508     History of Changes
Other Study ID Numbers: 04125, P30CA033572, CHNMC-04125, CDR0000628766
Study First Received: May 9, 2009
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board

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:
Breast Neoplasms
Breast Diseases
Carcinoma in Situ
Fibrocystic Breast Disease
Carcinoma, Lobular
Neoplasms by Site
Neoplasms
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014