Pilot Study of the Predictive Value of TREM1 Expression and Activation in Inflammation and Radio-induced Mammary Fibrosis (TREM-1)

Centre Francois Baclesse, Luxembourg

Status: Enrolling

Conditions: Breast Cancer; Radiation Toxicity; Fibrosis

Treatments: Biological: Blood sampling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04948840

TREM-1

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 5 patient groups

Group A

Other group

Description:

Patients with early grade ≥2 radio-induced epidermis Intervention : blood sample

Treatment:

Biological: Blood sampling

Group B

Other group

Description:

Patients with early grade 0-1 radiation-induced epidermis Intervention : blood sample

Treatment:

Biological: Blood sampling

Group C

No Intervention group

Description:

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 group

Description:

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 group

Description:

Control group : patients over 18 who have given their consent to the Blood Establishment for the use of their samples for research purposes.