NCT06929117

Brief Summary

Gastrointestinal polyps (GIPs) are unusual growths of epithelial tissue projecting from the mucosa of gastrointestinal tract (GIT) and one of the most common pathologies affecting GIT . They are either proliferative or neoplastic mucosal lesions that are commonly seen in the colon and less commonly occur in the esophagus, stomach and small intestine. They may remain asymptomatic or present as bleeding, pain and obstruction due to mass effect. However, the most important risk with the gastrointestinal polyps is the development of malignancy in some of these polyps . Gastric polyps include hyperplastic, fundic gland polyps, inflammatory fibroid polyp, adenomas like pyloric gland adenoma, and oxyntic gland adenoma. Hyperplastic gastric polyps rarely undergo neoplastic progression (1.5-2.1%) but are associated with an increased risk of synchronous cancer occurring elsewhere in the gastric mucosa . Gastric adenomas are true neoplasms and precursors of gastric cancer. Adenomas larger than 20 mm in width and villous histology have a higher risk of neoplastic progression . The presence of gastric adenomas is strongly associated with synchronous or metachronous gastric adenocarcinoma . Polyps of the small bowel are rare compared to those of the colo-rectum, with adenomas being most common and having more preference for the distal duodenum, ampullary, and periampullary region Colonic Polyps may be classified according to their gross appearance (sessile or pedunculated), histopathological features (hyperplastic, adenoma, etc.), and behavior (benign or malignant). The biggest concern is their ability to progress into adenocarcinoma, through the adenoma to carcinoma sequence due to genetic mutation .

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Sep 2025

Status
not yet 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 Progress55%
Sep 2025Dec 2026

First Submitted

Initial submission to the registry

April 8, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 16, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

1.2 years

First QC Date

April 8, 2025

Last Update Submit

April 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • To assess the presence and grade of dysplasia either low grade or high grade dysplasia in all examined polyps.

    To assess the presence and grade of dysplasia either low grade or high grade dysplasia in all examined polyps.

    during the period from January 2022 to December 2024

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This cross-sectional study will be conducted on all specimens with gastrointestinal polyps referred to the pathology Laboratories at ElRajhy hospital and surgical pathology lab in Assuit University Hospital during the period from January 2022 to December 2024 after approval of the committee of ethics of scientific research in Faculty of Medicine in Assuit University. The data will be collected from registers, medical files and reports from pathological department of Assiut University Hospital.Slides will be reviewed with Haematoxylin-Eosin stain to determinethe type of the polyps.

You may not qualify if:

  • Patients with insufficient data were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident pathology doctor

Study Record Dates

First Submitted

April 8, 2025

First Posted

April 16, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 16, 2025

Record last verified: 2025-04