Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01821196
First received: March 26, 2013
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Stomach Neoplasms
Procedure: biopsy

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: December 2012
Estimated Study Completion Date: December 2017
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: biopsy
Additional biopsies by means endoscopy, 5 from tumor tissue, 5 from adjacent normal mucosa per patient.
Procedure: biopsy
biopsies will be evaluated with immunohistochemistry and gene expression studies

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01821196

Locations
Norway
Department of Gastrointestinal Surgery, St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
St. Olavs Hospital
Investigators
Principal Investigator: Jon Erik Grønbech, MD PhD St. Olavs Hospital
  More Information

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01821196     History of Changes
Other Study ID Numbers: 210313
Study First Received: March 26, 2013
Last Updated: May 9, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by St. Olavs Hospital:
Tumor Markers, Biological
PGP9.5 protein, human
adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on September 30, 2014