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Molecular, Genetic, and Biochemical Effects Of Novel Therapies In Buccal Mucosal Cells

Phase 1
Not Enrolling

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Trial Information

Molecular, Genetic, and Biochemical Effects Of Novel Therapies In Buccal Mucosal Cells

A significant problem in drug development of novel small molecules is the lack of available
tissues (surrogate tissues) that allow for the assessment of the molecular and biochemical
effects of (targeted-therapies) drug action. The information obtained from surrogate
tissues might help us validate previous preclinical studies with those agents and also dose
them in a more rational way. Oral keratinocytes, which are accessible by non-invasive
means, might be useful to assess drug action. The proposed study seeks to investigate the
genetic, molecular, and biochemical effects of novel agents in oral buccal mucosal cells.
Patients already enrolled in Phase I and II clinical trials for neoplastic diseases at the
Clinical Center will undergo oral cytobrushing before and during therapy to determine the
molecular and biochemical effects of novel agents in the oral mucosa cells. Similar studies
will be performed in peripheral blood mononuclear cells. In order to validate to compare
and compare the oral cytobrush methodology, some of these subjects will undergo oral punch
biopsy studies. Some of these subjects will also undergo tumor biopsy, if accessible or

Inclusion Criteria


Patients (male, female, greater than or equal to age 18 years) enrolled in a clinical
trial at the Clinical Center receiving novel small molecules that modulate cell cycle
progression for the prevention and treatment of neoplastic diseases.

Able to sign informed consent.

Patient's primary NIH physician should agree with appropriateness of patient's
participation in the study.


Patients unable to undergo cytobrushing (significant mucositis).

Non-compliant patients.

Patients unable to provide baseline samples (patients already receiving therapy).

Exclusion for biopsy only: patients with significant bleeding diathesis, receiving active
anticoagulation or with platelets less than 10K.

Cognitively impaired subjects will be excluded from this trial.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

February 2003

Completion Date:

October 2005

Related Keywords:

  • Cancer
  • Molecular Targets
  • Keratinocytes
  • Cell Cycle
  • Small Molecule
  • Gene Expression
  • Pharmacodynamics
  • Surrogate Markers
  • Targeted Therapy
  • Buccal Mucosa
  • Pharmacogenomics
  • Oral Mucosa



National Institute of Dental And Craniofacial Research (NIDCR) Bethesda, Maryland  20892