Endoscopic Characteristics of Colonic Tumours

NCT01372696 | Withdrawn

• 1 other identifier: LST-SGM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to investigate whether polyps that look different at colonoscopy, have formed via different mutations and have different risks of turning into cancer.

Conditions

Colonic Polyp; Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Significant differences in molecular abnormalities.

  The aim of this project is to look for statistically significant differences in molecular abnormalities from the three known genetic pathways, between the two different morphological types, granular and non-granular, to potentially demonstrate that these different polyps form via different genetic pathways.

  Samples will be looked at and stored for approx 15 years

Study Arms (1)

Tissue sample

OTHER

Patients who consent to participate in this study will have a small sample of their polyp and normal tissue sent for molecular testing.

Other: Sample of polyp

Interventions

Sample of polyp OTHER

A small sample of the colonic polyp will be obtained for molecular testing. The remaining polyp will be sent for regular histological testing

Tissue sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intention to perform Endoscopic Mucosal Resection
• Polyp equal to or greater than 20mm
• over 18 years of age
• Able to give informed consent to involvement in trial

You may not qualify if:

• Pregnancy
• Lactation: currently breastfeeding
• Taken clopidogrel within 7 days
• Taken warfarin within 5 days
• Had full therapeutic dose unfractionated heparin within 6 hours
• Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
• Known clotting disorder

Sponsors & Collaborators

• Professor Michael Bourke: lead

Study Sites (1)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

MeSH Terms

Conditions

Colonic Polyps; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Michael Bourke

  Westmead Hospital - Endoscopy Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Michael Bourke

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 14, 2011
• Study Start: June 3, 2019
• Primary Completion: June 3, 2019
• Study Completion: June 3, 2019
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

AU (1)