Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342836
Status:
COMPLETED
Last Update Posted:
2007-03-23
First Post:
2006-06-19
Brief Title:
Analysis of Tissues From Patients in Trial of Myo-Inositol to Prevent Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-C-N146 | None | None | None |