NCT00373191

Brief Summary

RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at the effects of surgery, radiation therapy, chemotherapy, and hormone therapy on biomarkers in women with stage I, stage II, stage III breast cancer, or ductal carcinoma in situ that can be removed by surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

May 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

2.8 years

First QC Date

September 6, 2006

Last Update Submit

October 9, 2015

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerductal breast carcinoma in situ

Outcome Measures

Primary Outcomes (1)

  • Change in high-sensitivity C-reactive protein and gene methylation over time

    indefinite

Interventions

chemotherapyDRUG

N/A- not dictated by study

endocrine therapyDRUG

N/A- not dictated by study

DNA methylation analysisGENETIC

laboratory analysis

protein analysisGENETIC

laboratory analysis

laboratory biomarker analysisOTHER

laboratory analysis

questionnaire administrationOTHER

questionnaire

adjuvant therapyPROCEDURE

N/A- not dictated by study

conventional surgeryPROCEDURE

N/A- not dictated by study

radiation therapyRADIATION

N/A- not dictated by study

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with newly diagnosed ductal carcinoma in situ or invastive breast cancer.

DISEASE CHARACTERISTICS: * Histologically and/or cytologically confirmed stage I-III invasive breast carcinoma or ductal carcinoma in situ * Newly diagnosed disease * Patient must be initiating a new course of treatment for breast carcinoma, including surgery (mastectomy or lumpectomy with or without nodal evaluation) with or without any of the following: * Radiation therapy * Chemotherapy * Endocrine therapy * No known or suspected metastatic disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * No infectious or inflammatory condition, at the discretion of the principal investigator * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: * More than 6 months since prior surgery * Fine-needle aspirate or biopsy allowed * More than 6 months since prior radiotherapy * More than 6 months since prior chemotherapy * More than 6 months since prior endocrine therapy * No neoadjuvant endocrine therapy or chemotherapy * More than 2 weeks since prior and no concurrent regular use of any of the following: * Hydroxymethyl glutaryl coenzyme A reductase inhibitor (statin) * Nonsteroidal anti-inflammatory drug (NSAID)\* * Cyclooxygenase-2 (COX-2) inhibitor * Aspirin\* * Acetaminophen and opioid use is permitted as needed NOTE: \*Use of these products ≤ 2 times per week at standard over-the-counter doses allowed

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

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Interventions

Drug TherapyDNA MethylationChemotherapy, AdjuvantRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

TherapeuticsMethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic PhenomenaCombined Modality Therapy

Study Officials

  • Vered Stearns, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 7, 2006

Study Start

May 1, 2006

Primary Completion

February 1, 2009

Study Completion

December 1, 2013

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

US(1)