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NCT01790204 · ClinicalTrials.gov registry record · Phase 1

A Study of the Effects of PEITC on Oral Cells With Mutant p53

A Phase 1 study of Oral Cancer, sponsored by Georgetown University.

Completed
Registry status
Phase 1
Development phase
55
Enrollment target
1
Study location

NCT01790204 is a Phase 1 study of Oral Cancer that has completed, run by Georgetown University. The registered enrollment target is 55 participants, below the 210-participant average among 17 other Oral Cancer trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01790204, a Phase 1 study of Oral Cancer, has completed, sponsored by Georgetown University.

COMPLETED
Registry status
Phase 1
Development phase
55 participants
Enrollment target
1
Study location

Study Summary

The aim of this clinical trial is to examine the effects of phenethyl isothiocyanate (PEITC), a compound derived from cruciferous vegetables, on oral cells with mutant p53. The p53 protein's normal (wild-type) function within cells is to act as a tumor suppressor, or anti-cancer protein. When mutated, the p53 protein not only no longer executes the functions of a tumor suppressor, and it can gain functions as a pro-cancer protein.22 The proposed clinical trial will utilize oral cells collected from subjects who are heavy smokers. Since the subjects are regularly exposed to mutagenic chemicals it is the thought that their oral cells will contain measurable levels of mutant p53. The participants will consume watercress juice, which is rich in PEITC (See Figure 1). Previous studies in the laboratory showed PEITC selectively depletes mutant p53, and not wild type p53, in cell culture. Our hypothesis is that the ITC in the watercress juice will lead to the depletion of mutant p53 within the oral cells. This depletion could lead to a possible clinical application of this compound, such as chemopreventives or oncologic treatments of individuals with oral cancers.

Conditions Studied

Interventions

  • DIETARY_SUPPLEMENT Watercress Juice

Study Locations (1)

District of Columbia

  • Georgetown Clinical Research Unit - Washington D.C.

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2012-02
Est. Completion 2014-04
Phase Phase 1

Sponsor

Georgetown University

227 total trials

What the Registry Record Tells You About NCT01790204

The ClinicalTrials.gov registry entry for NCT01790204 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 210-participant average among 17 other Oral Cancer trials with a reported enrollment target (74% lower). The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Oral Cancer appearing as the primary indexed condition, and to 1 intervention - of which Watercress Juice is the first listed.

NCT01790204 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.

Frequently Asked Questions

What is clinical trial NCT01790204 about?

NCT01790204 is a clinical study titled "A Study of the Effects of PEITC on Oral Cells With Mutant p53". The aim of this clinical trial is to examine the effects of phenethyl isothiocyanate (PEITC), a compound derived from cruciferous vegetables, on oral cells with mutant p53. The p53 protein's normal (wild-type) function within cells is to act as a tumor suppressor, or anti-cancer protein. When mutate...

What is the current status of trial NCT01790204?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2012-02. Estimated completion is 2014-04.

What conditions does trial NCT01790204 study?

This clinical trial studies the following conditions: Oral Cancer.

What interventions are being tested in trial NCT01790204?

The interventions under investigation include: Watercress Juice (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01790204?

This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01790204 being conducted?

This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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