Protocol Number: 04-C-0138

Title:

Detection and Quantification of Changes in Levels of Protein Expression and Phosphorylation Status Using Human Hair Samples

Number:

04-C-0138

Summary:

This study will measure protein levels in hair follicles of patients with cancer to see if these levels can indicate the effectiveness of cancer treatment. Treatments such as chemotherapy, radiation therapy, immunotherapy or anti-angiogenic therapy (treatment that prevents formation of new blood vessels) may cause changes in protein levels or in the way proteins are regulated. Following these changes might help doctors determine if a treatment is effective or if a different dose or drug might be needed. If such measurements accurately reflect treatment response, they may be used in place of other, more difficult, tests, such as tumor biopsies.

Patients 18 years of age and older being treated at the NIH Clinical Center for a malignancy may enroll in this study. Participants have about 10 hair samples taken (5 from each side of the head) before they begin treatment and again at each Clinical Center visit. Additionally, information about the patients' medical history, current treatments and medications, and other factors that may affect protein levels is obtained from the patient or the patient's medical records.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Patients with a malignancy undergoing treatment at the Clinical Center are eligible.

Patients must have scalp hair.

Age greater than or equal to 18 years.

Patients must be willing to return to NIH for follow-up.

Patients must be able to sign informed consent.

EXCLUSION CRITERIA:

Patients unable to give informed consent.

Patients unwilling to return to the NIH for follow-up.

Patients less than 18 years of age.

Special Instructions:

Currently Not Provided

Keywords:

Quantitative Measurement

Layered Scanning

Phosphorylation

Monitoring

Recruitment Keyword(s):

Quantitative Measurement

Condition(s):

Quantitative Measurement

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Pegram MD, Konecny G, Slamon DJ. The molecular and cellular biology of HER2/neu gene amplification/overexpression and the clinical development of herceptin (trastuzumab) therapy for breast cancer. Cancer Treat Res. 2000;103:57-75. Review. No abstract available. PMID: 10948442

Traxler P. Tyrosine kinases as targets in cancer therapy - successes and failures. Expert Opin Ther Targets. 2003 Apr;7(2):215-34. PMID: 12667099

Lachgar S, Moukadiri H, Jonca F, Charveron M, Bouhaddioui N, Gall Y, Bonafe JL, Plouet J. Vascular endothelial growth factor is an autocrine growth factor for hair dermal papilla cells.J Invest Dermatol. 1996 Jan;106(1):17-23. PMID: 8592070

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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