Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma
Primary Purpose
Stomach Neoplasms
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
biopsy
Sponsored by
About this trial
This is an interventional basic science trial for Stomach Neoplasms focused on measuring Tumor Markers, Biological, PGP9.5 protein, human, adenocarcinoma
Eligibility 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).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
biopsy
Arm Description
Additional biopsies by means endoscopy, 5 from tumor tissue, 5 from adjacent normal mucosa per patient.
Outcomes
Primary Outcome Measures
Density of PGP9.5 in gastric adenocarcinoma related to TNM stage and survival of stomach cancer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01821196
Brief Title
Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma
Official Title
Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
due to insufficient quality of biopsy samples
Study Start Date
December 2012 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Tumor Markers, Biological, PGP9.5 protein, human, adenocarcinoma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
biopsy
Arm Type
Experimental
Arm Description
Additional biopsies by means endoscopy, 5 from tumor tissue, 5 from adjacent normal mucosa per patient.
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Description
biopsies will be evaluated with immunohistochemistry and gene expression studies
Primary Outcome Measure Information:
Title
Density of PGP9.5 in gastric adenocarcinoma related to TNM stage and survival of stomach cancer
Time Frame
5 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Erik Grønbech, MD PhD
Organizational Affiliation
St. Olavs Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma
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