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

NCT04948840 | Unknown

• 1 other identifier: TREM-1
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 3

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.

Conditions

Radiation Toxicity; Fibrosis; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  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

  after recruitment of all samples, an average of 2 years

Study Arms (5)

Group A

OTHER

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

Biological: Blood sampling

Group B

OTHER

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

Biological: Blood sampling

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.

Interventions

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).

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with late pathologic radio-induced fibrosis (more than 6 months after the end of radiotherapy), grade CTCAE v4.0 ≥ 3 vs.
• 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.
• Systemic inflammatory disease associated with individual radiosensitivity
• Dermatological pathology in the breast
• Radiotherapy having delivered an overdose\> 107% of the prescribed dose in at least 10% of the PTV
• Diabetes
• Active smoking
• Chronic systemic anti-inflammatory therapy, immunotherapy, immunosuppressants, anti-TNF

Sponsors & Collaborators

• Centre Francois Baclesse, Luxembourg: lead
• Inotrem: collaborator

Study Sites (3)

Centre Hospitalier de Metz Thionville

Metz, France

RECRUITING

Institut de Cancérologie de Lorraine

Nancy, France

RECRUITING

Centre François Baclesse

Esch-sur-Alzette, SUD, 4240, Luxembourg

RECRUITING

MeSH Terms

Conditions

Radiation Injuries; Fibrosis; Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Guillaume VOGIN, MD PhD

CONTACT

00352-2655661; guillaume.vogin@baclesse.lu

Charlotte LIEUNARD

CONTACT

00352-5711-67421; charlotte.lieunard@baclesse.lu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: July 2, 2021
• Study Start: April 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

LU (1); FR (2)