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Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01821196
Recruitment Status : Active, not recruiting
First Posted : March 29, 2013
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Stomach Neoplasms Procedure: biopsy

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma
Actual Study Start Date : December 2012
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Density of PGP9.5 in gastric adenocarcinoma related to TNM stage and survival of stomach cancer [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01821196     History of Changes
Other Study ID Numbers: 210313
First Posted: March 29, 2013    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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