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Immunohistochemical Analysis of Human Transbronchial Biopsy Specimens Collected in a Phase I Chemoprevention Trial of Myo-Inositol in Heavy Smokers Conducted Outside the Intramural NCI Program


Phase 1
40 Years
74 Years
Not Enrolling
Both
Lung Cancer, Precancerous Condition

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Trial Information

Immunohistochemical Analysis of Human Transbronchial Biopsy Specimens Collected in a Phase I Chemoprevention Trial of Myo-Inositol in Heavy Smokers Conducted Outside the Intramural NCI Program


OBJECTIVES:

- Determine the effect of inositol therapy on phoso-Akt levels in current or former
smokers with bronchial dysplastic lesions.

OUTLINE: Tissue samples collected on clinical trial BCCA-U98-0411 (before and after
treatment) are analyzed by immunohistochemistry for phospho-Akt levels.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of persistent bronchial dysplasia despite regular twice-daily treatment
with inhaled budesonide for 6 or 12 months on clinical trial BCCA-CIC-98-37

- Enrolled on clinical trial BCCA-U98-0411 to receive inositol

- Consented to tissue analysis in the original consent form

- Current or former smoker who has smoked at least 30 pack years

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Level of phospho-Akt by immunohistochemistry

Safety Issue:

No

Principal Investigator

Phillip Dennis, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000434508

NCT ID:

NCT00899730

Start Date:

Completion Date:

Related Keywords:

  • Lung Cancer
  • Precancerous Condition
  • non-small cell lung cancer
  • squamous lung dysplasia
  • Lung Neoplasms
  • Precancerous Conditions

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