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

Recruiting
18 years of age
Female
Phase N/A

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Overview

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.

Eligibility

Group A

  1. Patients over 18 years old,
  2. Breast cancer (adenocarcinoma in situ or invasive)
  3. Non-metastatic disease
  4. Radiotherapy after conservative surgery with irradiation of the breast alone and complement on the operating bed (optional) completed two to six months ago
  5. Absence of postoperative complications
  6. Early radio-induced epidermis grade ≥2 (CTCAE v4.0) persistent at inclusion
  7. Chest circumference <120 cm and Cup <E,
  8. Absence of breast reconstructive surgery,
  9. Signature of informed consent,
  10. Affiliation to a social security scheme for French patients.

Group B

  1. Patients over 18 years old,
  2. Breast cancer (adenocarcinoma in situ or invasive)
  3. Non-metastatic disease
  4. Radiotherapy after conservative surgery with irradiation of the breast alone and complement on the operating bed (optional), completed two to six months ago
  5. Absence of postoperative complications
  6. Early grade 0-1 radiation-induced epidermis (CTCAE v4.0) at inclusion
  7. Chest circumference <120 cm and Cup <E,
  8. Absence of breast reconstructive surgery,
  9. Signature of informed consent,
  10. Affiliation to a social security scheme for French patients.

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:
          -  10 patients with late pathologic radio-induced fibrosis (more than 6 months after the
             end of radiotherapy), grade CTCAE v4.0 ≥ 3 vs.
          -  10 patients without late pathological radio-induced fibrosis of grade CTCAE v4.0 ≤ 1
             (follow-up after RT ≥4 years)
        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:
          1. Systemic inflammatory disease associated with individual radiosensitivity
          2. Dermatological pathology in the breast
          3. Radiotherapy having delivered an overdose> 107% of the prescribed dose in at least 10%
             of the PTV
          4. Diabetes
          5. Active smoking
          6. Chronic systemic anti-inflammatory therapy, immunotherapy, immunosuppressants,
             anti-TNF

Study details

Radiation Toxicity, Fibrosis, Breast Cancer

NCT04948840

Centre Francois Baclesse, Luxembourg

27 January 2024

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