Study of Calgranulin A/B Levels in Patients With Newly Di... | NCT00900133

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

NCT00900133

Sponsor

Case Comprehensive Cancer Center

Status

Completed

Last Update Posted

Oct 2, 2015Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

immunoenzyme technique
laboratory biomarker analysis

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P30CA043703	U.S. NIH Grant/Contract		View source
CASE-7104	Other Identifier	Case Comprehensive Cancer Center

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Apr 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

May 9, 2009

First Submission Date that Met QC Criteria

May 9, 2009

First Posted Date

May 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2015

Last Update Posted Date

Oct 2, 2015Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
immunoenzyme technique	Other	Serum samples are evaluated by enzyme-linked immunosorbent assay for tumor marker expression.
laboratory biomarker analysis	Other	Blood draw following diagnosis of breast cancer to assess levels of circulating tumor markers, calgranulin A and calgranulin B.

Measure	Description	Time Frame
Correlation between circulating levels of calgranulin A and calgranulin B and the presence of estrogen receptor negative breast cancer		upon diagnosis

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Pink, PhD	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center		Cleveland	Ohio	44106	United States

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D007118	Immunoassay
D007158	Immunologic Techniques
D008919	Investigative Techniques
D007150	Immunohistochemistry