NCT00898508

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
563

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2005

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2019

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

13.9 years

First QC Date

May 9, 2009

Last Update Submit

June 23, 2025

Conditions

Breast Cancer

Keywords

invasive ductal breast carcinomainvasive lobular breast carcinomaductal breast carcinoma in situlobular breast carcinoma in situstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancer

Outcome Measures

Primary Outcomes (5)

  • Establishment of a specimen bank

    5 Years of specimen collection

  • Ability of the quantitative real-time reverse-transcriptase PCR (qRT-PCR) to distinguish between biopsy benign and malignant results

    5 years

  • Ability of the qRT-PCR to predict treatment response

    5 years

  • Ability of the qRT-PCR to predict relapse

    5 years

  • Ability of the qRT-PCR to perform as an independent prognostic factor

    5 years

Study Arms (2)

Normal benign breast disease or ductal carcinoma in situ

Genetic: gene expression analysisGenetic: mutation analysisGenetic: proteomic profilingGenetic: reverse transcriptase-polymerase chain reactionOther: fluorescent antibody techniqueOther: immunohistochemistry staining methodOther: laboratory biomarker analysisOther: liquid chromatographyOther: mass spectrometryOther: medical chart reviewProcedure: quality-of-life assessment

Invasive breast cancer

Genetic: gene expression analysisGenetic: mutation analysisGenetic: proteomic profilingGenetic: reverse transcriptase-polymerase chain reactionOther: fluorescent antibody techniqueOther: laboratory biomarker analysisOther: liquid chromatographyOther: mass spectrometryOther: medical chart reviewProcedure: quality-of-life assessment

Interventions

quality-of-life assessmentPROCEDURE
Invasive breast cancerNormal benign breast disease or ductal carcinoma in situ
gene expression analysisGENETIC
Invasive breast cancerNormal benign breast disease or ductal carcinoma in situ
mutation analysisGENETIC
Invasive breast cancerNormal benign breast disease or ductal carcinoma in situ
proteomic profilingGENETIC
Invasive breast cancerNormal benign breast disease or ductal carcinoma in situ
reverse transcriptase-polymerase chain reactionGENETIC
Invasive breast cancerNormal benign breast disease or ductal carcinoma in situ
fluorescent antibody techniqueOTHER
Invasive breast cancerNormal benign breast disease or ductal carcinoma in situ
immunohistochemistry staining methodOTHER
Normal benign breast disease or ductal carcinoma in situ
laboratory biomarker analysisOTHER
Invasive breast cancerNormal benign breast disease or ductal carcinoma in situ
liquid chromatographyOTHER
Invasive breast cancerNormal benign breast disease or ductal carcinoma in situ
mass spectrometryOTHER
Invasive breast cancerNormal benign breast disease or ductal carcinoma in situ
medical chart reviewOTHER
Invasive breast cancerNormal benign breast disease or ductal carcinoma in situ

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Tower Cancer Research Foundation

Beverly Hills, California, 90211, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

City of Hope Medical Group

Pasadena, California, 91105, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood sample and biopsy tissue

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, LobularCarcinoma, Intraductal, NoninfiltratingBreast Carcinoma In Situ

Interventions

Gene Expression ProfilingReverse Transcriptase Polymerase Chain ReactionFluorescent Antibody TechniqueImmunohistochemistryChromatography, LiquidMass Spectrometry

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma, DuctalAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Ductal, Lobular, and MedullaryCarcinoma in Situ

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic TechniquesChromatographyChemistry Techniques, Analytical

Study Officials

  • Robert Hickey, Ph.D.

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

August 1, 2005

Primary Completion

June 6, 2019

Study Completion

June 6, 2019

Last Updated

June 25, 2025

Record last verified: 2025-06

Locations

US(3)