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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Withdrawn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
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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).

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

    First Posted
    March 26, 2013
    Last Updated
    March 9, 2018
    Sponsor
    St. Olavs Hospital
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    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    Withdrawn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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