NCT00477139

Completed

A Pilot Study Evaluating the Immunologic Status of Patients ...

Stanford University Source

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Other study identifiers

Sponsor study identifier

BRSADJ0009

Secondary identifiers

97811

OTHER · Stanford University Alternate IRB Approval Number

BRSADJ0009

OTHER · Stanford University

Study Type

observational

Actual enrollment (reported)

4

Locations

1 country

Sites

1

Timeline

Study Start

January 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2010

Actual (reported)

Study Completion

September 2010

Actual (reported)

Brief Summary

This is a pilot study to gather preliminary data on the baseline immunologic status of patients with HER-2(+) breast cancer and to establish an immune monitoring laboratory for future clinical trial.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 4 participants
Study completion date: September 2010
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
May 18, 2007
Actual (reported)
First Posted
May 22, 2007
Actual (reported)
Study Start
January 2009
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
September 2010
Actual (reported)
Study Completion
September 2010
Actual (reported)

Last Updated: April 13, 2011
Status Verified: April 2011
Last Update Submitted: April 11, 2011

Conditions

Breast Cancer

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

individuals with HER-2 positive breast cancer.

You may qualify if:

Age \>= 18 years of age
Histologically documented breast cancer (hormone receptor (ER/PR) status may be either positive or negative) with or without metastatic disease.
HER-2(+) as determined by one of the following measurements. NOTE: HER-2(+) assessment may have been on initial diagnosis and need not be repeated for metastatic lesions
Immunohistochemistry (IHC) 3+, or
FISH + (HER-2 gene signal to centromere 17 signal \>2)

Sponsors & Collaborators

Stanford University
Otherlead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Dr. Ellie Guardino MD/PhD
Stanford University
PRINCIPAL INVESTIGATOR

Enrollment

4 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER

Study Record Dates

First Submitted

May 18, 2007

First Posted

May 22, 2007

Study Start

January 2009

Date type not reported

This date has not been verified as actual or estimated.

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No transfusion dependent patients and no transfusion within 30 days of leukopheresis

Documented labs within 7 days of donation consisting of:

WBC \> 4.0 K/ul \& \< 11.0 K/ul

platelet count \> 150,000/mm3

hemoglobin \> 11.0 g/dl.

Hematocrit \> 33 %

Weight \> 110 lbs

No blood donation in last 8 weeks (blood samples taken for standard of care less then 30 cc/week are acceptable)

Patients must not have active or unresolved infection.

No cold or flu sympton at time of donation

+4 more criteria

You may not qualify if:

The presence of another active malignancy
Pregnant, lactating, or nursing
Patients with prior myocardial infarction or active cardiac disease (e.g. congestive heart failure, clinically significant cardiac valvular disease or arrhythmia requiring medications, angina pectoris, uncontrolled hypertension, clinically significant pericardial effusion)

Contact the study team to confirm eligibility.

Primary Completion

September 2010

Actual (reported)

Study Completion

September 2010

Actual (reported)

Last Updated

April 13, 2011

Record last verified: 2011-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00477139
Data provider: ClinicalTrials.gov
Source updated: 2011-04-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:48 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations