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Prognostic Value of Tissue Factor (TF) in Blood t in Colorectal Cancer in Adults (TF)

25. juni 2019 opdateret af: University Hospital, Lille

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

Ukendt

Betingelser

Detaljeret beskrivelse

The study is to measure the TF in the blood, as well as ACE, C reactive protein and E-selectin. The TF will also be measured in the tissue removed during surgery.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

      • Lille, Frankrig, 59037
        • Rekruttering
        • Service de Chirurgie Digestive et de transplantation Hôpital Claude HURIEZ
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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
blood samples
Eksperimentel: Group control
Control - volunteers
Blood samples

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
TNM primary colorectal tumor stage
Tidsramme: Before surgery
soluble blood TNM value will be determined before surgery, and compared between groups.
Before surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
TF (blood levels of soluble TF)
Tidsramme: 1 , 6 , 12, 18 and 24 months .5 years
Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral
1 , 6 , 12, 18 and 24 months .5 years
TF intratumoral (blood levels of TF intratumoral)
Tidsramme: 1 , 6 , 12, 18 and 24 months .5 years
Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral
1 , 6 , 12, 18 and 24 months .5 years
E- selectin and CRP
Tidsramme: 1 , 6 , 12, 18 and 24 months. 5 years
Comparison - soluble TF with blood levels of other circulating proteins: E- selectin and CRP at different times of follow-up.
1 , 6 , 12, 18 and 24 months. 5 years
ACE
Tidsramme: 1 , 6 , 12, 18 and 24 months .5 years
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
1 , 6 , 12, 18 and 24 months .5 years
Interaction plate / tumor cell
Tidsramme: 1 , 6 , 12, 18 and 24 months .5 years
Quantifying the interaction plate / tumor cell by measuring intraplatelet regulatory proteins and angiogenesis markers of platelet activation and plasma compare the
1 , 6 , 12, 18 and 24 months .5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: ZERBIB Philippe, Prof, CHRU of Lille

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. juni 2009

Primær færdiggørelse (Forventet)

1. juni 2020

Studieafslutning (Forventet)

1. juni 2020

Datoer for studieregistrering

Først indsendt

24. juni 2014

Først indsendt, der opfyldte QC-kriterier

1. december 2014

Først opslået (Skøn)

2. december 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2019

Sidst verificeret

1. juni 2019

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Kolorektal cancer

Kliniske forsøg med Group CRC

3
Abonner