NCT00185809

Brief Summary

The purpose of this study is to examine breast cancers that express the protein (NIS) that may be found in malignant breast tissues and to evaluate proteins found in blood and their relationship to NIS, to test whether iodide can be concentrated by breast cells to possibly treat some breast cancers with radioactive iodine, and to calculate the amount of radioactive iodine entering breast cancer cells, how long your cancer retains the agent as well as how much is taken up by other organs, particularly the thyroid gland.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2000

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

November 1, 2000

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

July 20, 2010

Status Verified

July 1, 2010

Enrollment Period

7.8 years

First QC Date

September 12, 2005

Last Update Submit

July 16, 2010

Conditions

Breast Cancer

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligibility criteria include histological proof of invasive breast cancer and current radiological evidence of metastatic disease.

You may qualify if:

  • years of age or older
  • From whom informed consent can be obtained
  • Patient is able to provide a fluid (e.g. cyst fluid)
  • Patient with blood test that shows protein may allow iodide to accumulate in breast tissue

You may not qualify if:

  • Children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Archival tissue blocks and blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Irene L. Wapnir

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

November 1, 2000

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

July 20, 2010

Record last verified: 2010-07

Locations

US(1)