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Analysis of Tissues From Patients in Trial of Myo-Inositol to Prevent Lung Cancer

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00342836
Enrollment
20
Registered
2006-06-21
Start date
2005-04-30
Completion date
Unknown
Last updated
2007-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AKT

Keywords

Akt, Immunohistochemistry, Myoinositol, Bronchial Specimens, Phosphorylation

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.

Interventions

PROCEDUREAkt levels

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
Yes

Inclusion 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026