Pilot Study of the Predictive Value of TREM1 Expression and Activation in Inflammation and Radio-induced Mammary Fibrosis (TREM-1)
20 juni 2022 uppdaterad av: Centre Francois Baclesse, Luxembourg
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Metz, Frankrike
- Rekrytering
- Centre Hospitalier de Metz Thionville
-
Kontakt:
- Claire Gamelon - Benichou, MD
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Nancy, Frankrike
- Rekrytering
- Institut de Cancérologie de Lorraine
-
-
-
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SUD
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Esch-sur-Alzette, SUD, Luxemburg, 4240
- Rekrytering
- Centre François Baclesse
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Kontakt:
- Guillaume Vogin, MD PhD
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Kontakt:
- Charlotte Lieunard
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Group A
Patients with early grade ≥2 radio-induced epidermis Intervention : blood sample
|
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).
|
|
Övrig: Group B
Patients with early grade 0-1 radiation-induced epidermis Intervention : blood sample
|
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).
|
|
Inget ingripande: Group C
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
|
|
|
Inget ingripande: Group D
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
|
|
|
Inget ingripande: Group E
Control group : patients over 18 who have given their consent to the Blood Establishment for the use of their samples for research purposes.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Coorelate the amount of circulating TREM1 with the presence or absence of early persistent radiation-induced epidermis.
Tidsram: 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.
|
after recruitment of all samples, an average of 2 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Correlate the amount of circulating TREM1 with the presence or absence of late radio-induced fibrosis / atrophy
Tidsram: after recruitment of all samples, an average of 2 years
|
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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 april 2022
Primärt slutförande (Förväntat)
31 december 2024
Avslutad studie (Förväntat)
31 december 2024
Studieregistreringsdatum
Först inskickad
17 juni 2021
Först inskickad som uppfyllde QC-kriterierna
24 juni 2021
Första postat (Faktisk)
2 juli 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 juni 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 juni 2022
Senast verifierad
1 juni 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TREM-1
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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