- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00899691
Study of Hair Samples From Patients With Cancer
Detection and Quantification of Changes in Levels of Protein Expression and Phosphorylation Status Using Human Hair Samples
RATIONALE: Studying samples of hair in the laboratory from patients with cancer may help doctors identify biomarkers related to cancer and predict how well patients will respond to treatment.
PURPOSE: This laboratory study is looking at hair samples from patients with cancer.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine whether layered membrane technology can quantitatively measure the expression, activity, and localization of cell growth control and signaling proteins in hair samples from patients with cancer.
- Correlate changes in protein expression with expected changes based on planned therapy in these patients.
OUTLINE: This is a pilot, multicenter study.
Hair samples are obtained from patients at baseline and at the end of study. The samples are assayed for proteins and phosphorylation status using layered membrane technology. Proteins analyzed may include vascular endothelial growth factor receptor (VEGFR), Erk1/2, Akt, epidermal growth factor receptor (EGFR), and c-KIT.
PROJECTED ACCRUAL: A total of 190 patients will be accrued for this study within 3 years.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Diagnosis of malignancy
- Undergoing treatment at the National Cancer Institute's Clinical Center
- Must have scalp hair
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Study Plan
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Obtain data on the detection and quantification of changes in levels of protein expression and phosphorylation status using human hair samples at baseline and after completion of study
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 040138
- 04-C-0138
- CDR0000363803
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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