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CompletedNCT00900133Updated Oct 2, 2015

Study of Calgranulin A/B Levels in Patients With Newly Diagnosed Stage I,II,III Breast Cancer

An observational study in Breast Cancer, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-02.

Sponsored by Case Comprehensive Cancer Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Measuring levels of calgranulin A and calgranulin B in the blood of patients with breast cancer in the laboratory may help doctors identify and learn more about biomarkers related to breast cancer.

PURPOSE: This laboratory study is measuring calgranulin A and calgranulin B levels in the blood of patients with newly diagnosed stage I, stage II, or stage III breast cancer.

Read the detailed description

OBJECTIVES:

  • Determine circulating levels of calgranulin A and calgranulin B in patients with estrogen receptor negative or estrogen receptor positive, newly diagnosed, primary stage I-III adenocarcinoma of the breast.

OUTLINE: This is a pilot study.

Patients undergo a blood draw following diagnosis of breast cancer to assess levels of circulating tumor markers, calgranulin A and calgranulin B. Serum samples are evaluated by enzyme-linked immunosorbent assay for tumor marker expression.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

02

Conditions studied

  • Breast Cancer

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Keywords

  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
03

In context

Breast Neoplasms

12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's enrollment of 60 is below the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Case Comprehensive Cancer Center is the lead sponsor of 493 studies on the registry; 59 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients With Newly Diagnosed Stage I,II,III Breast Cancer. Primary care clinic

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary adenocarcinoma of the breast

    • Stage I-III disease
    • No evidence of metastatic disease
    • Newly diagnosed disease
  • Hormone receptor status:

    • Estrogen receptor-positive- or -negative tumor

PATIENT CHARACTERISTICS:

Sex

  • Not specified

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant
  • No Crohn's disease
  • No arthritis
  • No psoriasis
  • No lupus erythematosus
  • No multiple sclerosis
  • No other severe active inflammation
  • Not C-reactive protein positive
  • No HIV positivity
  • No other serious medical or psychiatric illness

PRIOR CONCURRENT THERAPY:

Radiotherapy

  • No prior radiotherapy for breast cancer

Surgery

  • No prior organ transplantation

Other

  • No prior systemic therapy for breast cancer
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
60 participants (actual)
Biospecimen retention
Samples with dna

Interventions

  • Otherimmunoenzyme technique

    Serum samples are evaluated by enzyme-linked immunosorbent assay for tumor marker expression.

  • Otherlaboratory biomarker analysis

    Blood draw following diagnosis of breast cancer to assess levels of circulating tumor markers, calgranulin A and calgranulin B.

06

What researchers measure

Primary outcomes

  1. Correlation between circulating levels of calgranulin A and calgranulin B and the presence of estrogen receptor negative breast cancer

    Time frame: upon diagnosis

07

Study locations

1 site
  • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
    Cleveland, Ohio 44106, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2005, a primary completion of Apr 2006 and a completion of Dec 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2009
First posted
May 12, 2009
Start
Jan 2005
Primary completionActual
Apr 2006
CompletionActual
Dec 2006
Last update
Oct 2, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00900133
First posted
May 12, 2009
Start date
Jan 2005
Primary completion
Apr 2006
Completion
Dec 2006
Last update
Oct 2, 2015

Study contacts

John Pink, PhD
principal investigator · Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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