NCT05231915

Brief Summary

In Martinique, prostate cancer incidence rates are nowadays among the highest worldwide with a high incidence of early-onset and familial forms. We identified a rare heterozygous germline variant c.853delT (p.Ter285Lysfs) rs77179853, reported only among patients of African ancestry with a minor allele frequency of 3.2%. We search to estimate the prevalence of this variant in a sample of prevalent prostate cancer cases managed in urology consultation in Martinique .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
465

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

April 9, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2025

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

3.6 years

First QC Date

February 1, 2022

Last Update Submit

March 26, 2026

Conditions

Keywords

Prostate cancerMartiniqueHOXB13 c.853delT prevalence

Outcome Measures

Primary Outcomes (1)

  • Estimation of prevalence of Allelic frequency of the HOXB13 c.853delT mutation

    Mutation is detected using Next Generation Sequencing (NGS) technique

    At baseline

Study Arms (1)

HOXB13 c.853delT mutation

OTHER

Mutation is detected using Next Generation Sequencing (NGS) technique

Genetic: HOXB13 c.853delT mutation

Interventions

Identify the Allelic frequency of the HOXB13 c.853delT mutation in patients with a cancer prostate in Martinique

HOXB13 c.853delT mutation

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult man over 18 years of age living in Martinique with a prostate cancer whatever the histological type and the stage, managed in urology consultation (public and private sectors of Martinique)
  • Sporadic or familial form
  • Informed with a written consent signed by the participant and the investigator
  • Affiliate or beneficiary of french social security.

You may not qualify if:

  • Patient who is not of African descent
  • Refusal to participate.
  • Patients not affiliated to french social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Martinique

Fort-de-France, 97261, Martinique

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2022

First Posted

February 9, 2022

Study Start

April 9, 2021

Primary Completion

November 27, 2024

Study Completion

March 9, 2025

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations