NCT03471403

Brief Summary

The purpose of this study is to collect prospective observational data regarding patients with diagnosed Familial Adenomatous Polyposis (FAP) undergoing cold snare polypectomy for duodenal adenomas

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
30mo left

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Oct 2017Oct 2028

Study Start

First participant enrolled

October 10, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2028

Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

10 years

First QC Date

March 13, 2018

Last Update Submit

March 25, 2025

Conditions

Familial Adenomatous Polyposis

Keywords

Cold snare polypectomy

Outcome Measures

Primary Outcomes (1)

  • Number of serious and non-serious adverse events

    * bleeding risk * adenoma recurrence

    Three years

Secondary Outcomes (5)

  • Duration of endoscopic procedure

    Three years

  • Perforation (peri-procedure and delayed)

    Three years

  • Pain post procedure

    Three years

  • Hospital readmission

    Three years

  • Change in Spigelman stage

    Three years

Study Arms (1)

FAP

FAP patients with duodenal adenomas

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosed Familial Adenomatous Polyposis

You may qualify if:

  • Patient's diagnosed with a confirmed diagnosis of FAP (genetic testing) and able to give informed consent to involvement in trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent
  • Patients already commenced on endoscopic surveillance for FAP.

You may not qualify if:

  • Patient's with known strictures/stenosis
  • Pregnancy
  • Patients who did not consent to study
  • Bleeding diathesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

RECRUITING

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Condition Hierarchy (Ancestors)

Adenomatous PolypsAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesIntestinal PolyposisGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Michael J Bourke, MBBS

CONTACT

88905555michael@citywestgastro.com.au

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastrointestinal Endoscopy

Study Record Dates

First Submitted

March 13, 2018

First Posted

March 20, 2018

Study Start

October 10, 2017

Primary Completion (Estimated)

October 10, 2027

Study Completion (Estimated)

October 10, 2028

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations

AU(1)