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NCT00055380 · ClinicalTrials.gov registry record · Phase 1
Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients
A Phase 1 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
NCT00055380: Completed Phase 1 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
NCT00055380 is a Phase 1 study that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 120 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00055380, a Phase 1 study, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
Study Summary
This study will examine the effects of certain investigational anti-cancer drugs on the genetic and protein makeup of cells. The findings will be entered into a database that may be used to: 1) determine the optimal dose of drug that will provide the most benefit with the least harmful side effects; and 2) predict which patients will have a greater chance of developing side effects or a greater chance of benefiting from the drug. Patients 18 years of age and older who are receiving the anti-cancer drugs flavopiridol or perifosine in an NIH clinical trial may be eligible for this study. Participants will undergo the following procedures both before starting treatment and during the first treatment cycle to look for genetic or chemical changes produced in response to the study drug: * Blood draws. * Buccal cell brushings: Collection of buccal cells (cells lining the inside of the cheeks) from the inside of the cheeks using a soft bristle brush for a few seconds several times. The patient then rinses the mouth with salt water for 1 minute and then spits into a cup. * Buccal cell biopsies (on both sides of the mouth): For this procedure, a local anesthetic is given to numb the biopsy area. Then, a small piece of tissue from the inner lining of the mouth is removed with a small sharp cookie-cutter instrument. The biopsy findings will be compared with those of the cheek brushings to see if the information is similar. * Tumor biopsies: In patients whose tumor is easily accessible, such as the skin abdominal fluid, tissue biopsies will be requested. Depending on the type and location of the tumor, the biopsy may be done with a forceps, a large needle (needle biopsy), a cookie-cutter instrument (punch biopsy), or a small knife (excisional biopsy). All of these procedures are done with a local anesthetic.
Interventions
- PROCEDURE Oral cytobrushing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2003-02 |
| Est. Completion | 2005-10 |
| Phase | Phase 1 |
What the finished NCT00055380 record still lists
NCT00055380 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher).
The record links to 0 conditions, and to 1 intervention - of which Oral cytobrushing is the first listed.
NCT00055380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00055380 about?
NCT00055380 is a clinical study titled "Chemical and Genetic Effects of the Experimental Anti-Cancer Drugs in Cheek Cells in Cancer Patients". This study will examine the effects of certain investigational anti-cancer drugs on the genetic and protein makeup of cells. The findings will be entered into a database that may be used to: 1) determine the optimal dose of drug that will provide the most benefit with the least harmful side effects;...
What is the current status of trial NCT00055380?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2003-02. Estimated completion is 2005-10.
What interventions are being tested in trial NCT00055380?
The interventions under investigation include: Oral cytobrushing (PROCEDURE).
Who is sponsoring clinical trial NCT00055380?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00055380's enrollment target sits among peer trials
120 479th of 2000 higher than 1,503 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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