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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 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.

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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

FieldValue
Enrollment Target 120 participants
Start Date 2003-02
Est. Completion 2005-10
Phase Phase 1

What the Registry Record Tells You About NCT00055380

The ClinicalTrials.gov registry entry for NCT00055380 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Oral cytobrushing is the first listed.

NCT00055380 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.