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

Breast Cancer Clinical Trial

— TREM-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04948840
• Other study ID #: TREM-1
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2022
• Source: Centre Francois Baclesse, Luxembourg
• Contact: Guillaume VOGIN, MD PhD
• Phone: 00352-2655661
• Email: guillaume.vogin[@]baclesse.lu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Breast Cancer
• Fibrosis
• Inflammation
• Radiation Toxicity

Intervention

Biological:
• Blood sampling
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).

Locations

Country	Name	City	State
France	Centre Hospitalier de Metz Thionville	Metz
France	Institut de Cancérologie de Lorraine	Nancy
Luxembourg	Centre François Baclesse	Esch-sur-Alzette	SUD

Sponsors (2)

Lead Sponsor	Collaborator
Centre Francois Baclesse, Luxembourg	Inotrem

Countries where clinical trial is conducted

France,  Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Intrinsic characteristics of the TREM1 blood assay in ELISA technique	Intrinsic characteristics of the TREM1 blood assay in ELISA technique	after recruitment of all samples, an average of 2 years
Secondary	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