Pilot Study of the Predictive Value of TREM1 Expression and Activation in Inflammation and Radio-induced Mammary Fibrosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- Coorelate the amount of circulating TREM1 with the presence or absence of early persistent radiation-induced epidermis.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •for groups A, B, C, D:
- •Systemic inflammatory disease associated with individual radiosensitivity
- •Dermatological pathology in the breast
- •Radiotherapy having delivered an overdose> 107% of the prescribed dose in at least 10% of the PTV
- •Active smoking
- •Chronic systemic anti-inflammatory therapy, immunotherapy, immunosuppressants, anti-TNF
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Coorelate the amount of circulating TREM1 with the presence or absence of early persistent radiation-induced epidermis.
Time Frame: 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 Outcomes
- Intrinsic characteristics of the TREM1 blood assay in ELISA technique(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(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(after recruitment of all samples, an average of 2 years)