Breast CancerNCT00898508
Studying Blood and Tumor Tissue Samples in Women With Invasive Breast Cancer, Ductal or Lobular Carcinoma in Situ, or Benign Breast Disease
An observational study of Breast Cancer, run by City of Hope Medical Center at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- gene expression analysis, mutation analysis and proteomic profiling
- Type of treatment
- Surgery or procedure
- How many people
- 563 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Aug 2005to 6 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: City of Hope New patients
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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tower Cancer Research Foundation
Beverly Hills, California, 90211
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
City of Hope Medical Group
Pasadena, California, 91105
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- gene expression analysis, mutation analysis, proteomic profiling, reverse transcriptase-polymerase chain reaction, fluorescent antibody technique
- Keywords
- 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
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ductal, Breast, Carcinoma, Lobular, Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
mutation analysisGenetic
proteomic profilingGenetic
reverse transcriptase-polymerase chain reactionGenetic
fluorescent antibody techniqueOther
laboratory biomarker analysisOther
liquid chromatographyOther
mass spectrometryOther
medical chart reviewOther
quality-of-life assessmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Normal benign breast disease or ductal carcinoma in situ | Not described Receives: 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 | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of a specimen bank
Measured: 5 Years of specimen collection
Ability of the quantitative real-time reverse-transcriptase PCR (qRT-PCR) to distinguish between biopsy benign and malignant results
Measured: 5 years
Ability of the qRT-PCR to predict treatment response
Measured: 5 years
Ability of the qRT-PCR to predict relapse
Measured: 5 years
Ability of the qRT-PCR to perform as an independent prognostic factor
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start19 Aug 2005
- Primary completion6 Jun 2019
- Study completion6 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert Hickey, Ph.D., Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898508
- Sponsor's protocol ID
- 04125
- Other IDs
- P30CA033572, CHNMC-04125, CDR0000628766
- Status last verified
- Oct 2026
- First submitted
- 9 May 2009
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Tumor Markers for Molecular Diagnosis of Breast Diseases and Monitoring of Breast Cancer Treatment and Follow-up
- ClinicalTrials.gov ID
- NCT00898508
- Acronym / sponsor ID
- 04125
- Conditions
- Breast Cancer
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Aug 2005 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- City of Hope New patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene expression analysis | Genetic | Invasive breast cancer, Normal benign breast disease or ductal carcinoma in situ |
| mutation analysis | Genetic | Invasive breast cancer, Normal benign breast disease or ductal carcinoma in situ |
| proteomic profiling | Genetic | Invasive breast cancer, Normal benign breast disease or ductal carcinoma in situ |
| reverse transcriptase-polymerase chain reaction | Genetic | Invasive breast cancer, Normal benign breast disease or ductal carcinoma in situ |
| fluorescent antibody technique | Other | Invasive breast cancer, Normal benign breast disease or ductal carcinoma in situ |
| immunohistochemistry staining method | Other | Normal benign breast disease or ductal carcinoma in situ |
| laboratory biomarker analysis | Other | Invasive breast cancer, Normal benign breast disease or ductal carcinoma in situ |
| liquid chromatography | Other | Invasive breast cancer, Normal benign breast disease or ductal carcinoma in situ |
| mass spectrometry | Other | Invasive breast cancer, Normal benign breast disease or ductal carcinoma in situ |
| medical chart review | Other | Invasive breast cancer, Normal benign breast disease or ductal carcinoma in situ |
| quality-of-life assessment | Procedure or surgery | Invasive breast cancer, Normal benign breast disease or ductal carcinoma in situ |
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Hickey, Ph.D. principal investigator
City of Hope Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by City of Hope Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of a specimen bank (time frame: 5 Years of specimen collection). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.