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

Early Phase 1

• Conditions: Colorectal Cancer
• Interventions: Biological: Group CRC; Biological: Group control

• Registration Number: NCT02304978
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2009-06-22
• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-02
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-25
• Last Update Posted: 2019-06-26
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group CRC	Group CRC	patient with a colorectal cancer
Group control	Group control	Control - volunteers

Primary Outcome Measures

Name	Time	Method
TNM primary colorectal tumor stage	Before surgery	soluble blood TNM value will be determined before surgery, and compared between groups.

Secondary Outcome Measures

Name	Time	Method
TF (blood levels of soluble TF)	1 , 6 , 12, 18 and 24 months .5 years	Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral
TF intratumoral (blood levels of TF intratumoral)	1 , 6 , 12, 18 and 24 months .5 years	Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral
E- selectin and CRP	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.
ACE	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
Interaction plate / tumor cell	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

Trial Locations

Locations (1)

Service de Chirurgie Digestive et de transplantation Hôpital Claude HURIEZ; 🇫🇷 Lille, France