Pilot Study of the Predictive Value of TREM1 Expression and Activation in Inflammation and Radio-induced Mammary Fibrosis

Not Applicable

Recruiting

• Conditions: Fibrosis; Breast Cancer; Radiation Toxicity
• Interventions: Biological: Blood sampling

• Registration Number: NCT04948840
• Lead Sponsor: Centre Francois Baclesse, Luxembourg

Brief Summary

Breast cancer is the most common cancer in the world. Half of patients with such cancer are treated with radiation therapy. Some patients will develop cutaneous or subcutaneous fibrosis, more or less bothersome. Several studies have shown a correlation between an inflammatory reaction and a protein, called TREM-1. But to date, no link has been proven between TREM-1 and inflammation / fibrosis in the phenomena of fibrosis induced by radiotherapy in patients with breast cancer. Our study aims to understand the involvement of this TREM-1 protein in the development of fibrosis or radio-epidermis in patients with breast cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-07-02
• Study Start: 2022-04-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-20
• Last Update Posted: 2022-06-23
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Blood sampling	Patients with early grade ≥2 radio-induced epidermis Intervention : blood sample
Group B	Blood sampling	Patients with early grade 0-1 radiation-induced epidermis Intervention : blood sample

Primary Outcome Measures

Name	Time	Method
Coorelate the amount of circulating TREM1 with the presence or absence of early persistent radiation-induced epidermis.	after recruitment of all samples, an average of 2 years	Correlate the amount of circulating TREM1 with the presence or absence of early persistent radiation-induced epidermis.

Secondary Outcome Measures

Name	Time	Method
correlate TREM-1 expression with circulating markers of inflammation such as IL-6, CRP, and fibrosis such as TGF-beta, IL-1beta, TNF-alpha	after recruitment of all samples, an average of 2 years	correlate TREM-1 expression with circulating markers of inflammation such as IL-6, CRP, and fibrosis such as TGF-beta, IL-1beta, TNF-alpha
Intrinsic characteristics of the TREM1 blood assay in ELISA technique	after recruitment of all samples, an average of 2 years	Intrinsic characteristics of the TREM1 blood assay in ELISA technique
Correlate the amount of circulating TREM1 with the presence or absence of late radio-induced fibrosis / atrophy	after recruitment of all samples, an average of 2 years	Correlate the amount of circulating TREM1 with the presence or absence of late radio-induced fibrosis / atrophy

Trial Locations

Locations (3)

Centre Hospitalier de Metz Thionville; 🇫🇷 Metz, France

Institut de Cancérologie de Lorraine; 🇫🇷 Nancy, France

Centre François Baclesse; 🇱🇺 Esch-sur-Alzette, SUD, Luxembourg