Clinical trial · Interventional
A Research Pilot Study in Healthy Volunteers to Evaluate Biomarkers for Novel Anticancer Treatments
A Research Pilot Study in Healthy Volunteers to Evaluate Biomarkers for Novel Anticancer Treatments.
NCT00586417CI-TRIAL-00012790terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| punch biopsy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- This is a basic research study. There are no treatments with drugs or devices. Wound healing is being studied in healthy volunteers.
- interventionNames
- Other: punch biopsy
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 14 days
Secondary outcomes (1)
- measure
- 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.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: LOCAL (Raleigh-Durham, Chapel Hill) candidates only!!! * Age \>18 years. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.