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NCT01821196 Clinical Trial

Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma

Stomach Neoplasms Clinical Trial

Official title:
Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01821196
Other study ID # 210313
Secondary ID
Status Withdrawn
Phase N/A
First received March 26, 2013
Last updated March 9, 2018
Start date December 2012
Est. completion date February 2018

Study information
Verified date March 2018
Source St. Olavs Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• biopsy
biopsies will be evaluated with immunohistochemistry and gene expression studies

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
St. Olavs Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Density of PGP9.5 in gastric adenocarcinoma related to TNM stage and survival of stomach cancer 5 years
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