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| Name | Class |
|---|---|
| Inotrem | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | Patients with early grade ≥2 radio-induced epidermis Intervention : blood sample |
|
| Group B | Other | Patients with early grade 0-1 radiation-induced epidermis Intervention : blood sample |
|
| Group C | No Intervention | 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 | |
| Group D | No Intervention | 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 | |
| Group E | No Intervention | Control group : patients over 18 who have given their consent to the Blood Establishment for the use of their samples for research purposes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Biological | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | after recruitment of all samples, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | after recruitment of all samples, an average of 2 years |
| Intrinsic characteristics of the TREM1 blood assay in ELISA technique |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillaume VOGIN, MD PhD | Contact | 00352-2655661 | guillaume.vogin@baclesse.lu | |
| Charlotte LIEUNARD | Contact | 00352-5711-67421 | charlotte.lieunard@baclesse.lu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Metz Thionville | Recruiting | Metz | France |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D005355 | Fibrosis |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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The are 5 groups of patients:
For groups A and B, the only intervention consists in a blood sample.
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Intrinsic characteristics of the TREM1 blood assay in ELISA technique |
| 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 | after recruitment of all samples, an average of 2 years |
| Institut de Cancérologie de Lorraine | Recruiting | Nancy | France |
|
| Centre François Baclesse | Recruiting | Esch-sur-Alzette | SUD | 4240 | Luxembourg |
|
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |