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

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ClinicalTrials.gov Identifier: NCT02304978
Recruitment Status : Recruiting
First Posted : December 2, 2014
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: Group CRC Biological: Group control Early Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prognostic Value of Tissue Factor (TF) in Blood t in Colorectal Cancer in Adults
Actual Study Start Date : June 22, 2009
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group CRC
patient with a colorectal cancer
Biological: Group CRC
blood samples

Experimental: Group control
Control - volunteers
Biological: Group control
Blood samples




Primary Outcome Measures :
  1. TNM primary colorectal tumor stage [ Time Frame: Before surgery ]
    soluble blood TNM value will be determined before surgery, and compared between groups.


Secondary Outcome Measures :
  1. TF (blood levels of soluble TF) [ Time Frame: 1 , 6 , 12, 18 and 24 months .5 years ]
    Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral

  2. TF intratumoral (blood levels of TF intratumoral) [ Time Frame: 1 , 6 , 12, 18 and 24 months .5 years ]
    Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral

  3. E- selectin and CRP [ Time Frame: 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.

  4. ACE [ Time Frame: 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

  5. Interaction plate / tumor cell [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304978


Contacts
Contact: ZERBIB Philippe, Professeur +00333 20 44 44 64 p-zerbib@chru-lille.fr
Contact: LOUNI Chanaz, CRA +0033320414445 chanaz.louni@chru-lille.fr

Locations
France
Service de Chirurgie Digestive et de transplantation Hôpital Claude HURIEZ Recruiting
Lille, France, 59037
Contact: ZERBIB Philippe, Prof    03 20 44 44 64    p-zerbib@chru-lille.fr   
Sponsors and Collaborators
University Hospital, Lille
Investigators
Study Director: ZERBIB Philippe, Prof CHRU of LILLE

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02304978     History of Changes
Other Study ID Numbers: 2008-09/0908
2009-A00264-53 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
colorectal cancer
Tissular factor
TF

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Thromboplastin
Hemostatics
Coagulants