Clinical trial NCT00342836: Analysis of Tissues From Patients in Trial of Myo-Inositol to Prevent Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: AKT
Keywords: Akt
Immunohistochemistry
Myoinositol
Bronchial Specimens
Phosphorylation
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-06-21
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: This study will examine tissue specimens from patients participating in a trial of high-dose myo-inositol to prevent lung cancer. The trial, conducted at the British Columbia Cancer Agency-Vancouver Cancer Center (BCCA-VCC), includes people who have pre-cancerous changes in the air passages of their lungs.

The BCCA-VCC trial was designed to determine side effects of taking large amounts of the food supplement myo-inositol for longer than a month and if the supplement can help smokers stop smoking.

The current study will look at the levels of a substance called Akt in tissue samples obtained from air passages of subjects in the BCCA-VCC trial. Akt is activated by tobacco components and can be found in lung tumor specimens and pre-cancerous lesions. Myo-inositol may affect Akt levels and help prevent progression of pre-cancerous lesions to cancer.

People participating in the BCCA-VCC phase 1 myo-inositol trial are eligible for this study. Tissue samples obtained from air passages of these patients during their participation in that study will be sent to the National Cancer Institute for analysis of Akt levels.

Detailed description: Human transbronchial biopsy specimens collected under protocol study numbers CDR0000302633; BCCA-U98-0411; BCCA-C02-0298 will be immunohistochemically stained for activated Akt using phospho-specific antibodies. These samples are part of a phase I chemoprevention trial of myo-inositol being conducted in Vancouver, BC by the British Columbia Cancer Agency in collaboration with the National Cancer Institute (NCI). The transbronchial specimens will be sent to the NCI for analysis of activated AKT. The study aims to determine whether myo-inositol, a putative inhibitor of the upstream kinase phosphatidylinositol 3-kinase, can alter activated Akt levels in smokers with bronchial dysplasia.

Eligibility criteria: * INCLUSION CRITERIA:

Any patients entered into phase 1 myo-inositol trial are eligible for inclusion, provided that they have consented to tissue analysis in the original consent form.

EXCLUSION CRITERIA:

None anticipated at this time.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency (BCCA)
Study officials:
References:
citation: Hecht SS, Kenney PM, Wang M, Upadhyaya P. Dose-response study of myo-inositol as an inhibitor of lung tumorigenesis induced in A/J mice by benzo. Cancer Lett. 2001 Jun 10;167(1):1-6. doi: 10.1016/s0304-3835(01)00454-2.