Brief Summary

Development of a polygenic risk score based on somatic and germline genetic information from patients with colorectal cancer

Trial Health

On Track

Trial Health Score

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

Enrollment

500

participants targeted

Target at P75+ for all trials

Timeline

17mo left

Started Mar 2025

Typical duration for all trials

Geographic Reach

1 country

9 active sites

Status

enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

2.6 years study duration

Study Progress45%

Mar 2025Oct 2027

Study Start

First participant enrolled

March 14, 2025

Completed

18 days until next milestone

First Submitted

Initial submission to the registry

April 1, 2025

Completed

7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

2.6 years

First QC Date

April 1, 2025

Last Update Submit

April 1, 2025

Conditions

Colo-rectal Cancer Polygenic Risk Score Somatic Mutation Hereditary Cancer Germline Mutations Cancer Predisposition Syndrome

Outcome Measures

Primary Outcomes (1)

Elaboration of Poligenic Risk
A germline and somatic genetic mapping in Brazilian patients with colon adenocarcinoma, including ancestry, for the development of a polygenic risk score system applicable to the Brazilian population.
36mo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Of the 500 patients included, approximately 56% will be recruited from participants self-identified as brown, black, or indigenous, with the remaining percentage distributed between white and yellow. Of these individuals, at least 50% will be women, corresponding to the sex and race distribution in the Brazilian population reported in the latest IBGE census in 2022.

You may qualify if:

\> 18 years;
Histologically confirmed diagnosis of colorectal cancer;
Have available tumor material for somatic sequencing, obtained from biopsy or routine surgery;
Sign the informed consent form (ICF) for the study.

You may not qualify if:

Pregnants

Contact the study team to confirm eligibility.