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

NCT02304978 | Completed Early Phase 1

• 2 other identifiers: 2008-09/09082009-A00264-53
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Colorectal Cancer

Keywords

colorectal cancer; Tissular factor; TF

Outcome Measures

Primary Outcomes (1)

• TNM primary colorectal tumor stage

  soluble blood TNM value will be determined before surgery, and compared between groups.

  Before surgery

Secondary Outcomes (5)

• TF (blood levels of soluble TF)

  1 , 6 , 12, 18 and 24 months .5 years

• TF intratumoral (blood levels of TF intratumoral)

  1 , 6 , 12, 18 and 24 months .5 years

• E- selectin and CRP

  1 , 6 , 12, 18 and 24 months. 5 years

• ACE

  1 , 6 , 12, 18 and 24 months .5 years

• Interaction plate / tumor cell

  1 , 6 , 12, 18 and 24 months .5 years

Study Arms (2)

Group CRC

EXPERIMENTAL

patient with a colorectal cancer

Biological: Group CRC

Group control

EXPERIMENTAL

Control - volunteers

Biological: Group control

Interventions

Group CRC BIOLOGICAL

blood samples

Group CRC

Group control BIOLOGICAL

Blood samples

Group control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-

You may not qualify if:

• 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 -

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Service de Chirurgie Digestive et de transplantation Hôpital Claude HURIEZ

Lille, 59037, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• ZERBIB Philippe, Prof

  CHRU of LILLE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: December 2, 2014
• Study Start: June 22, 2009
• Primary Completion: May 26, 2015
• Study Completion: May 26, 2015
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)