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Study of Hair Samples From Patients With Cancer

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ClinicalTrials.gov Identifier: NCT00899691
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : March 15, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

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.


Condition or disease Intervention/treatment
Unspecified Adult Solid Tumor, Protocol Specific Genetic: protein expression analysis

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 : Observational
Estimated Enrollment : 190 participants
Official Title: Detection and Quantification of Changes in Levels of Protein Expression and Phosphorylation Status Using Human Hair Samples
Study Start Date : March 2005
Actual Study Completion Date : October 2008



Primary Outcome Measures :
  1. 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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899691


Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven K. Libutti, MD NCI - Surgery Branch

ClinicalTrials.gov Identifier: NCT00899691     History of Changes
Other Study ID Numbers: 040138
04-C-0138
CDR0000363803
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012

Keywords provided by National Institutes of Health Clinical Center (CC):
unspecified adult solid tumor, protocol specific