Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma
Preclinical studies at our institution, based on a genetic mouse model of stomach cancer, strongly suggest that innervation of the stomach wall is deeply involved in tumorigenesis of stomach cancer. The data indicate that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®)in the stomach wall inhibits the development of cancer as well as reduces already established tumor volume in the stomach in this mouse model. Gene expression data indicate that vagotomy suppresses protein gene product 9.5 (PGP9.5). The expression of PGP9.5 is highly specific for the density of neurons and the diffuse neuroendocrine system. The investigators will take biopsies from tumors and adjacent normal mucosa either by means of endoscopy and/or from operative specimens from participants treated or evaluated for stomach cancer at the Department of Gastrointestinal Surgery, St Olavs Hospital, Trondheim University Hospital. The biopsies will be evaluated with immunohistochemistry and gene expression studies for the presence and density of PGP9.5. These data will be correlated to stage evaluation (TNM) and survival.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma|
- Density of PGP9.5 in gastric adenocarcinoma related to TNM stage and survival of stomach cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2017|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Additional biopsies by means endoscopy, 5 from tumor tissue, 5 from adjacent normal mucosa per patient.
biopsies will be evaluated with immunohistochemistry and gene expression studies
Please refer to this study by its ClinicalTrials.gov identifier: NCT01821196
|Department of Gastrointestinal Surgery, St Olavs Hospital|
|Principal Investigator:||Jon Erik Grønbech, MD PhD||St. Olavs Hospital|