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).

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Biological: Group CRC; Biological: Group control

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
• Enrollment (Actual): 26
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Service de Chirurgie Digestive et de transplantation Hôpital Claude HURIEZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TNM primary colorectal tumor stage	soluble blood TNM value will be determined before surgery, and compared between groups.	Before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TF (blood levels of soluble TF)	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)	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	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	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Study Director: ZERBIB Philippe, Prof, CHRU of Lille

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2009
• Primary Completion (Actual): May 26, 2015
• Study Completion (Actual): May 26, 2015

Study Registration Dates

• First Submitted: June 24, 2014
• First Submitted That Met QC Criteria: December 1, 2014
• First Posted (Estimated): December 2, 2014

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: colorectal cancer; Tissular factor; TF
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 2008-09/0908; 2009-A00264-53 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No