NCT06625788

Brief Summary

The aim is to clinically, endoscopically, and molecularly characterize patients with multiple colorectal adenomas, establish the indication for genetic testing to rule out hereditary syndromes and identify the genes to be included, and improve endoscopic screening recommendations for these patients and their relatives.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
42mo left

Started Oct 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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 Progress32%
Oct 2024Oct 2029

First Submitted

Initial submission to the registry

October 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

October 3, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

October 1, 2024

Last Update Submit

October 1, 2024

Conditions

Colorectal Cancer Control and Prevention

Keywords

polyppolyposiscolorectal polyposismultiple colorectal adenomacolorectal cancer

Outcome Measures

Primary Outcomes (1)

  • colorectal cancer incidence

    incidence of invasive CRC

    5 years

Study Arms (1)

Patients with 10 or more colorectal adenomas

patients with 10 or more cumulative colorectal adenomas histologically confirmed

Eligibility Criteria

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

patients with 10 or more colorectal adenoma in whom heredutary consictions have been previously excluded

You may qualify if:

  • or more adenomas
  • \>18 years

You may not qualify if:

  • Inhereted condictions
  • Inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociacion Española de Gastroenterologua

Madrid, 28020, Spain

Location

MeSH Terms

Conditions

PolypsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 3, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2029

Last Updated

October 3, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)