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

University Hospital, Lille

Status and phase: Completed; Early Phase 1

Conditions: Colorectal Cancer

Treatments: Biological: Group CRC; Biological: Group control

Study type: Interventional

Funder types: Other

Identifiers

NCT02304978

2008-09/0908

2009-A00264-53 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

26 participants in 2 patient groups

Group CRC

Experimental group

Description:

patient with a colorectal cancer

Treatment:

Biological: Group CRC

Group control

Experimental group

Description:

Control - volunteers

Treatment:

Biological: Group control