Overview

This trial is active, not recruiting.

Condition stomach neoplasms
Treatment biopsy
Sponsor St. Olavs Hospital
Start date December 2012
End date December 2013
Trial size 15 participants
Trial identifier NCT01821196, 210313

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Additional biopsies by means endoscopy, 5 from tumor tissue, 5 from adjacent normal mucosa per patient.
biopsy
biopsies will be evaluated with immunohistochemistry and gene expression studies

Primary Outcomes

Measure
Density of PGP9.5 in gastric adenocarcinoma related to TNM stage and survival of stomach cancer
time frame: 5 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Fifteen patients evaluated- or treated for suspected or verified gastric adenocarcinoma at the Department of Gastrointestinal Surgery, St Olavs Hospital, Trondheim University Hospital - informed consent Exclusion Criteria: - General contraindications for endoscopy with biopsies (i.e. bleeding disorders or use of anticoagulants).

Additional Information

Official title Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma
Principal investigator Jon Erik Grønbech, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by St. Olavs Hospital.