An interventional study of Blood sampling in Radiation Toxicity, Fibrosis and Breast Cancer, sponsored by Centre Francois Baclesse, Luxembourg. Status unknown at 3 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-23.
Sponsored by Centre Francois Baclesse, Luxembourg · Not applicable, Interventional, and Other
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.
Browse Inflammation studies →Centre Francois Baclesse, Luxembourg is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Group A
Group B
Groups C, D
Patients included in the SPLICIRAD study who have formulated their agreement for the use of supernumerary samples at the time of inclusion:
Group E Patients over 18 who have given their consent to the Blood Establishment for the use of their samples for research purposes.
Non-inclusion criteria for groups A, B, C, D:
Patients with early grade ≥2 radio-induced epidermis Intervention : blood sample
Biological: Blood sampling
Patients with early grade 0-1 radiation-induced epidermis Intervention : blood sample
Biological: Blood sampling
Patients with late pathologic radio-induced fibrosis (more than 6 months after the end of radiotherapy), grade CTCAE v4.0 ≥ 3 No intervention : Blood sample already collected from another study and patients agree to use their blood sample for another research
Patients without late pathologic radio-induced fibrosis of grade CTCAE v4.0 ≤ 1 (follow-up after RT ≥4 years) No intervention : Blood sample already collected from another study and patients agree to use their blood sample for another research
Control group : patients over 18 who have given their consent to the Blood Establishment for the use of their samples for research purposes.
Blood sample of 7 mL whole venous blood in an EDTA citrate tube (4.5 mL) and a PAXgene Blood RNA tube (2.5 mL).
Coorelate the amount of circulating TREM1 with the presence or absence of early persistent radiation-induced epidermis.
Correlate 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 late radio-induced fibrosis / atrophy
Correlate the amount of circulating TREM1 with the presence or absence of late radio-induced fibrosis / atrophy
Time frame: after recruitment of all samples, an average of 2 years
Intrinsic characteristics of the TREM1 blood assay in ELISA technique
Intrinsic characteristics of the TREM1 blood assay in ELISA technique
Time frame: 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
correlate TREM-1 expression with circulating markers of inflammation such as IL-6, CRP, and fibrosis such as TGF-beta, IL-1beta, TNF-alpha
Time frame: after recruitment of all samples, an average of 2 years
Plan to share: No
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This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Centre Francois Baclesse, Luxembourg