Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01821196

Enrollment

Registered

2013-03-29

Start date

2012-12-31

Completion date

2018-02-28

Last updated

2018-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomach Neoplasms

Keywords

Tumor Markers, Biological, PGP9.5 protein, human, adenocarcinoma

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.

Interventions

PROCEDUREbiopsy

biopsies will be evaluated with immunohistochemistry and gene expression studies

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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).

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026