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

Primary Purpose

Radiation Toxicity, Fibrosis, Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
Centre Francois Baclesse, Luxembourg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Radiation Toxicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier de Metz ThionvilleRecruiting
  • Institut de Cancérologie de LorraineRecruiting
  • Centre François BaclesseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

No Intervention

No Intervention

No Intervention

Arm Label

Group A

Group B

Group C

Group D

Group E

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Intrinsic characteristics of the TREM1 blood assay in ELISA technique
Intrinsic characteristics of the TREM1 blood assay in ELISA technique
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

Full Information

First Posted
June 17, 2021
Last Updated
June 20, 2022
Sponsor
Centre Francois Baclesse, Luxembourg
Collaborators
Inotrem
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1. Study Identification

Unique Protocol Identification Number
NCT04948840
Brief Title
Pilot Study of the Predictive Value of TREM1 Expression and Activation in Inflammation and Radio-induced Mammary Fibrosis
Acronym
TREM-1
Official Title
Pilot Study of the Predictive Value of TREM1 Expression and Activation in Inflammation and Radio-induced Mammary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse, Luxembourg
Collaborators
Inotrem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Toxicity, Fibrosis, Breast Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Other
Arm Description
Patients with early grade ≥2 radio-induced epidermis Intervention : blood sample
Arm Title
Group B
Arm Type
Other
Arm Description
Patients with early grade 0-1 radiation-induced epidermis Intervention : blood sample
Arm Title
Group C
Arm Type
No Intervention
Arm 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
Arm Title
Group D
Arm Type
No Intervention
Arm 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
Arm Title
Group E
Arm Type
No Intervention
Arm Description
Control group : patients over 18 who have given their consent to the Blood Establishment for the use of their samples for research purposes.
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Description
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).
Primary Outcome Measure Information:
Title
Coorelate the amount of circulating TREM1 with the presence or absence of early persistent radiation-induced epidermis.
Description
Correlate the amount of circulating TREM1 with the presence or absence of early persistent radiation-induced epidermis.
Time Frame
after recruitment of all samples, an average of 2 years
Secondary Outcome Measure Information:
Title
Correlate the amount of circulating TREM1 with the presence or absence of late radio-induced fibrosis / atrophy
Description
Correlate the amount of circulating TREM1 with the presence or absence of late radio-induced fibrosis / atrophy
Time Frame
after recruitment of all samples, an average of 2 years
Title
Intrinsic characteristics of the TREM1 blood assay in ELISA technique
Description
Intrinsic characteristics of the TREM1 blood assay in ELISA technique
Time Frame
after recruitment of all samples, an average of 2 years
Title
correlate TREM-1 expression with circulating markers of inflammation such as IL-6, CRP, and fibrosis such as TGF-beta, IL-1beta, TNF-alpha
Description
correlate TREM-1 expression with circulating markers of inflammation such as IL-6, CRP, and fibrosis such as TGF-beta, IL-1beta, TNF-alpha
Time Frame
after recruitment of all samples, an average of 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Group A Patients over 18 years old, Breast cancer (adenocarcinoma in situ or invasive) Non-metastatic disease Radiotherapy after conservative surgery with irradiation of the breast alone and complement on the operating bed (optional) completed two to six months ago Absence of postoperative complications Early radio-induced epidermis grade ≥2 (CTCAE v4.0) persistent at inclusion Chest circumference <120 cm and Cup <E, Absence of breast reconstructive surgery, Signature of informed consent, Affiliation to a social security scheme for French patients. Group B Patients over 18 years old, Breast cancer (adenocarcinoma in situ or invasive) Non-metastatic disease Radiotherapy after conservative surgery with irradiation of the breast alone and complement on the operating bed (optional), completed two to six months ago Absence of postoperative complications Early grade 0-1 radiation-induced epidermis (CTCAE v4.0) at inclusion Chest circumference <120 cm and Cup <E, Absence of breast reconstructive surgery, Signature of informed consent, 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume VOGIN, MD PhD
Phone
00352-2655661
Email
guillaume.vogin@baclesse.lu
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte LIEUNARD
Phone
00352-5711-67421
Email
charlotte.lieunard@baclesse.lu
Facility Information:
Facility Name
Centre Hospitalier de Metz Thionville
City
Metz
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Gamelon - Benichou, MD
Facility Name
Institut de Cancérologie de Lorraine
City
Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anais Stefani, MD
Facility Name
Centre François Baclesse
City
Esch-sur-Alzette
State/Province
SUD
ZIP/Postal Code
4240
Country
Luxembourg
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Vogin, MD PhD
First Name & Middle Initial & Last Name & Degree
Charlotte Lieunard

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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