- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02304978
Prognostic Value of Tissue Factor (TF) in Blood t in Colorectal Cancer in Adults (TF)
Severity of colorectal cancer (CRC) is evaluated by its local staging, locoregional and general ( presence of metastases , usually liver ). This is the most common cancer in France and, despite surgical treatment of the primary tumor, it is still subject to a high mortality rate due to metastatic evolution, mainly hepatic .
There is currently no specific marker for predicting cancer, the same hardly changed , which would modulate the aggressive therapeutic strategy . antigen (CEA) is used in the monitoring of JRC made.Tissue factor (TF) is the VII tissue factor receptor. it initiates the coagulation cascade. it was noted as a true cell marker tumorale1 aggressiveness. Corroborating evidence that the way the TF plays an important role in the invasive and metastatic potential of CRC. First, various human cancer cell lines express the FT colic. Furthermore, there is a relationship between the importance of monocyte TF expression and the evolutionary potential of human CRC.
The investigators hypothesize that these interest intra-platelet and plasma markers are a reflection of tumor angiogenic potential. And the investigators will verify the superiority of their preoperative levels in the CRC group compared with the control group, normalization of postoperative after surgical resection rates and their possible re-ascent in case of tumor recurrence in the CRC group.
The levy to one month in controls allow us to verify the absence of secondary modification to laparotomy, the colectomy and general anesthesia.
The investigators assume that the rate of soluble TF in peripheral blood of the holders of CRC patients may be a marker of invasion and aggression (i.e. prognosis).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiekontakt
- Navn: ZERBIB Philippe, Professeur
- Telefonnummer: +00333 20 44 44 64
- E-mail: p-zerbib@chru-lille.fr
Undersøgelse Kontakt Backup
- Navn: LOUNI Chanaz, CRA
- Telefonnummer: +0033320414445
- E-mail: chanaz.louni@chru-lille.fr
Studiesteder
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Lille, Frankrig, 59037
- Rekruttering
- Service de Chirurgie Digestive et de transplantation Hôpital Claude HURIEZ
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Kontakt:
- ZERBIB Philippe, Prof
- Telefonnummer: 03 20 44 44 64
- E-mail: p-zerbib@chru-lille.fr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
All patients, adults, holders of CRC with or without MH in whom surgical resection HEALING is planned .
For witnesses:
- Patients without CCR (preoperative colonoscopy). This control population will verify normal values regulators of angiogenesis recently defined and specificity of these vis-à-vis markers CCR-
Exclusion Criteria:
all situations where the plasma levels of FT antigen are high, in particular:
- Patients with unstable angina or myocardial infarction in the acute phase (not older than two months)
- Severe sepsis (hospitalization)
- Cirrhosis stage Child C
- Chronic renal failure requiring renal replacement extra
- Patients with microvascular complications of diabetes
- Vasculitis
Pregnancy and lactation patient on oral contraceptives, or having hormone replacement therapy for menopause
- Patients with extrahepatic metastases
- Patients underwent emergency surgery
- Persons not able to consent
For witnesses:
History of cancer, inflammatory disease, diabetes, regular intake of anti inflammatory drugs.
If during colonoscopy, colorectal cancer was detected, the control patients were excluded from the study -
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Group CRC
patient with a colorectal cancer
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blood samples
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Eksperimentel: Group control
Control - volunteers
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Blood samples
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
TNM primary colorectal tumor stage
Tidsramme: Before surgery
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soluble blood TNM value will be determined before surgery, and compared between groups.
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Before surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
TF (blood levels of soluble TF)
Tidsramme: 1 , 6 , 12, 18 and 24 months .5 years
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Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral
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1 , 6 , 12, 18 and 24 months .5 years
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TF intratumoral (blood levels of TF intratumoral)
Tidsramme: 1 , 6 , 12, 18 and 24 months .5 years
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Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral
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1 , 6 , 12, 18 and 24 months .5 years
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E- selectin and CRP
Tidsramme: 1 , 6 , 12, 18 and 24 months. 5 years
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Comparison - soluble TF with blood levels of other circulating proteins: E- selectin and CRP at different times of follow-up.
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1 , 6 , 12, 18 and 24 months. 5 years
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ACE
Tidsramme: 1 , 6 , 12, 18 and 24 months .5 years
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Evaluation of the prognostic value of blood levels of soluble TF and that of ACE blood on the incidence of Metastases Hepatic in patients undergoing CRC and / or hepatic
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1 , 6 , 12, 18 and 24 months .5 years
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Interaction plate / tumor cell
Tidsramme: 1 , 6 , 12, 18 and 24 months .5 years
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Quantifying the interaction plate / tumor cell by measuring intraplatelet regulatory proteins and angiogenesis markers of platelet activation and plasma compare the
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1 , 6 , 12, 18 and 24 months .5 years
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: ZERBIB Philippe, Prof, CHRU of Lille
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2008-09/0908
- 2009-A00264-53 (Anden identifikator: ID-RCB number, ANSM)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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