Clinical Trials Logo
  1. Home
  2. Stomach Neoplasms
  3. NCT01821196
  4. Details
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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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
See also
  Status Clinical Trial Phase
Recruiting NCT01950572 - Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Recruiting NCT05161572 - Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer Phase 2
Not yet recruiting NCT04351867 - A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer Phase 3
Recruiting NCT02887612 - ctDNA for Prediction of Relapse in Gastric Cancer
Active, not recruiting NCT02930291 - The Effect of Preoperative Inflammation-based Scores on Postoperative Morbidity and Mortality for Laparoscopic Gastrectomy
Completed NCT02649348 - Effects of Prehabilitation in Gastric Cancer Patients With Metabolic Syndrome on Perioperative Outcome N/A
Recruiting NCT02310230 - An Evaluation of the Utility of the ExSpiron Respiratory Variation Monitor During Upper GI Endoscopy N/A
Active, not recruiting NCT01609309 - Multicenter Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer (CLASS-01) Phase 3
Completed NCT00375999 - Docetaxel and Epirubicin in Advanced Gastric Cancer Phase 2
Completed NCT00382720 - Docetaxel and Oxaliplatin in Gastric Cancer Phase 2
Completed NCT00980382 - A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma Phase 1/Phase 2
Recruiting NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Phase 2
Active, not recruiting NCT05602935 - Efficacy and Safety of SOX Regimen Combined With Camrelizumab as Neoadjuvant Treatment in Locally Advanced Gastric Cancer: a Phase II, Single-arm Study Phase 2
Recruiting NCT05033392 - PD-1 Blockade With JS001 Plus Neoadjuvant Chemotherapy for Gastric/Gastroesophageal Junction Cancer Phase 2
Completed NCT04539769 - Impact of the Type of Reconstruction Methods on Diabetes Following Laparoscopic Distal Gastrectomy in Patients With Gastric Cancer and Type 2 Diabetes Phase 2
Active, not recruiting NCT02930278 - The Effect of Preoperative Hemotologic Markers on Postoperative Long-term and Short-term Outcomes for Laparoscopic Gastrectomy
Active, not recruiting NCT02845986 - Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Gastric Cancer Phase 2
Completed NCT02902575 - The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy N/A
Recruiting NCT04222114 - Comparing the Efficacy and Safety of Intra-peritoneal Infusion of Catumaxomab and Treatment of Investigator Choice in Patients With Advanced Gastric Carcinoma With Peritoneal Metastasis Phase 3
Recruiting NCT05068180 - Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients Phase 4