Radiation ToxicityTREM-1NCT04948840
Pilot Study of the Predictive Value of TREM1 Expression and Activation in Inflammation and Radio-induced Mammary Fibrosis
A study testing Blood sampling in people with Radiation Toxicity and Fibrosis, run by Centre Francois Baclesse, Luxembourg at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiation Toxicity, Fibrosis, Breast Cancer
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Apr 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier de Metz Thionville
Metz
Claire Gamelon - Benichou, MD
- Recruiting
Institut de Cancérologie de Lorraine
Nancy
Anais Stefani, MD
Luxembourg1 site, 1 recruiting
- Recruiting
Centre François Baclesse
Esch-sur-Alzette, SUD, 4240
Guillaume Vogin, MD PhD
Charlotte Lieunard
About this study
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
- Being tested
- Blood sampling
- Medical subject headings
- Radiation Injuries, Fibrosis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Patients with early grade ≥2 radio-induced epidermis Intervention : blood sample Receives: Biological: Blood sampling |
| Group B | Other | Patients with early grade 0-1 radiation-induced epidermis Intervention : blood sample Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Correlate the amount of circulating TREM1 with the presence or absence of late radio-induced fibrosis / atrophy
Measured: after recruitment of all samples, an average of 2 years
Intrinsic characteristics of the TREM1 blood assay in ELISA technique
Intrinsic characteristics of the TREM1 blood assay in ELISA technique
Measured: 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
correlate TREM-1 expression with circulating markers of inflammation such as IL-6, CRP, and fibrosis such as TGF-beta, IL-1beta, TNF-alpha
Measured: after recruitment of all samples, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Apr 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse, Luxembourg
- Sponsor type
- University, hospital or other
- Collaborators
- Inotrem
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948840
- Sponsor's protocol ID
- TREM-1
- Acronym
- TREM-1
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2021
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Predictive Value of TREM1 Expression and Activation in Inflammation and Radio-induced Mammary Fibrosis
- ClinicalTrials.gov ID
- NCT04948840
- Acronym / sponsor ID
- TREM-1 / TREM-1
- Conditions
- Radiation Toxicity, Fibrosis, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Francois Baclesse, LuxembourgUniversity, hospital or other
- Collaborators
- Inotrem
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Biological: Blood samplingPatients with early grade ≥2 radio-induced epidermis Intervention : blood sample |
| Group B | Other | Biological: Blood samplingPatients with early grade 0-1 radiation-induced epidermis Intervention : blood sample |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sample of 7 mL whole venous blood in an EDTA citrate tube (4.5 mL) and a PAXgene Blood RNA tube (2.5 mL). | Biological | Group A, Group B |
Primary outcome
Coorelate 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
Correlate the amount of circulating TREM1 with the presence or absence of early persistent radiation-induced epidermis.
3 secondary outcomes
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
Intrinsic characteristics of the TREM1 blood assay in ELISA technique
Time frame: 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
Time frame: after recruitment of all samples, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Radiation Toxicity and Fibrosis, run by Centre Francois Baclesse, Luxembourg at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume VOGIN, MD PhD (00352-2655661, guillaume.vogin@baclesse.lu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coorelate 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.