A Research Pilot Study in Healthy Volunteers to Evaluate Biomarkers for Novel Anticancer Treatments

NCT00586417 | Terminated

• 1 other identifier: Pro00012830
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this study is to determine the feasibility and the variability of several biomarker assays in normal subjects that are relevant to tumor biology and novel anti-cancer treatments, with the goal of refining these assays for use in future therapeutic studies.

Conditions

Healthy

Keywords

angiogenesis; tumor angiogenesis; biomarkers; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• To refine techniques needed to describe the expected values and variability of multiple angiogenic and tumor growth factor levels in blood and urine, using ELISA and other evolving protein and gene expression and cell capture technologies.

  14 days

Secondary Outcomes (1)

• To describe the expected values and variability of multiple angiogenic and tumor growth factor levels in blood and urine, including VEGF, bFGF, PDGF, PDEGF, TGFβ, TSP1, and MMP2 and MMP9. Other angiogenic and tumor growth factors may also be evaluated.

  14 days

Study Arms (1)

1

EXPERIMENTAL

This is a basic research study. There are no treatments with drugs or devices. Wound healing is being studied in healthy volunteers.

Other: punch biopsy

Interventions

punch biopsy OTHER

skin biopsies

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LOCAL (Raleigh-Durham, Chapel Hill) candidates only!!!
• Age \>18 years.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Subjects may not have major medical or other conditions that might affect the study assays: major surgery or trauma in the past six months, known current pregnancy, diabetes, history of coagulation abnormalities.
• Subjects may not be receiving any investigational agents.
• Subjects may not be taking medications that are likely to significantly affect wound healing or clotting (eg steroids, anti-coagulants, hormonal contraceptives), aspirin \> 325mg/d or other NSAID \> once per day, birth control pills or other hormonal contraceptives.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• HIV-positive patients and patients on combination antiretroviral therapy are ineligible because of the potential for alterations in normal wound healing responses. In addition, subjects who currently have a malignancy or have had malignant disease in the past 5 years are not eligible.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Officials

• Herb Hurwitz, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 4, 2008
• Study Start: January 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 3, 2013

Record last verified: 2013-12

Locations

US (1)