Prevalence of the c.853delT Mutation of the HOXB13 Gene in Prostate Cancer in Martinique

Prostate Cancer Clinical Trial

— HOXB13_Mart  

Official title:

Prevalence of the c.853delT Mutation of the HOXB13 Gene in Prostate Cancer in Martinique

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05231915
• Other study ID #: 19_RIPH2_14
• Status: Recruiting
• Phase: N/A
• Start date: April 9, 2021
• Est. completion date: April 9, 2025

Study information

• Verified date: October 2023
• Source: University Hospital Center of Martinique
• Contact: Régine MARLIN
• Phone: +596 596 30 67 35
• Email: regine.marlin[@]chu-martinique.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Description:

In Martinique, prostate cancer incidence rates are nowadays among the highest worldwide with a high incidence of early-onset and familial forms. Despite the demonstration of a strong familial component, identification of the genetic basis for hereditary prostate cancer is challenging. The screening of the HOXB13 gene is recommended for men who develop an early-onset and/or familial Pca . In fact, the HOXB13 germline variant G84E (rs138213197) was described in men of European descent with prostate cancer risk. Other germline variants were detected in ethnic groups. More recently, we reported a rare HOXB13 mutation, specifically c.853delT (pTer285Lysfs) that appears to be contribute to young Prostate Cancer cases in Martinique. This variant is a stop loss reported only among patients of African ancestry .

Regarding the allele frequency of the HOXB13 c.853delT variant observed in the Pca cohort, it will be necessary to assess relative and absolute Pca risks for HOXB13 c.853delT carriers. This information is essential to use this variant in genetic counseling. We propose to sequence the HOXB13 gene of all prostate cancers cases managed in urology consultation in Martinique.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 465
• Est. completion date: April 9, 2025
• Est. primary completion date: April 9, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patient who is not of African descent

• Refusal to participate.

• Patients not affiliated to french social security

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Martinique	Centre Hospitalier Universitaire de Martinique	Fort-de-France

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Center of Martinique

Country where clinical trial is conducted

Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of prevalence of Allelic frequency of the HOXB13 c.853delT mutation	Mutation is detected using Next Generation Sequencing (NGS) technique	At baseline