NCT01132560

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in tissue samples from patients with ductal breast carcinoma in situ.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Shorter than P25 for all trials

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

March 5, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1 month

First QC Date

May 26, 2010

Last Update Submit

May 16, 2017

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situ

Outcome Measures

Primary Outcomes (1)

  • Ipsilateral local failure (first event of invasive or DCIS recurrence)

    1 month

Secondary Outcomes (1)

  • Contralateral breast cancer (invasive or DCIS)

    1 month

Interventions

RNA analysisGENETIC
gene expression analysisGENETIC
reverse transcriptase-polymerase chain reactionGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples submitted for research from patient enrolled on E5194

DISEASE CHARACTERISTICS: * Diagnosis of ductal breast carcinoma in situ * Enrolled on clinical trial ECOG-E5194 * Local surgery without radiotherapy * Treated or not treated with tamoxifen * Available tissue samples * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

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

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Interventions

Gene Expression ProfilingReverse Transcriptase Polymerase Chain Reaction

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)

Genetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Lawrence J. Solin, MD, FACR

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2010

First Posted

May 28, 2010

Study Start

March 5, 2010

Primary Completion

April 5, 2010

Study Completion

April 5, 2010

Last Updated

May 17, 2017

Record last verified: 2017-05