Clinical trial NCT04948840: Pilot Study of the Predictive Value of TREM1 Expression and Activation in Inflammation and Radio-induced Mammary Fibrosis
Official title: Pilot Study of the Predictive Value of TREM1 Expression and Activation in Inflammation and Radio-induced Mammary Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiation Toxicity
Fibrosis
Breast Cancer
Lead sponsor: Centre Francois Baclesse, Luxembourg
Sponsor class: OTHER
Collaborators: name: Inotrem
First posted: 2021-07-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The are 5 groups of patients:

* Group A and B : cohort prospective
* Groups C and D : cohort retrospective
* Group E : control group, samples from French blood establishment

For groups A and B, the only intervention consists in a blood sample.
Primary purpose: OTHER

Brief 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.


Eligibility 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

Primary outcomes:
measure: Coorelate the amount of circulating TREM1 with the presence or absence of early persistent radiation-induced epidermis.
timeFrame: after recruitment of all samples, an average of 2 years
Secondary outcomes:
measure: Correlate the amount of circulating TREM1 with the presence or absence of late radio-induced fibrosis / atrophy
timeFrame: after recruitment of all samples, an average of 2 years
measure: Intrinsic characteristics of the TREM1 blood assay in ELISA technique
timeFrame: after recruitment of all samples, an average of 2 years
measure: correlate TREM-1 expression with circulating markers of inflammation such as IL-6, CRP, and fibrosis such as TGF-beta, IL-1beta, TNF-alpha
timeFrame: after recruitment of all samples, an average of 2 years
Other outcomes:
Locations:
city: Metz
country: France
facility: Centre Hospitalier de Metz Thionville
city: Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Esch-sur-Alzette
country: Luxembourg
facility: Centre François Baclesse
state: SUD
Study officials:
References: