Clinical trial NCT02304978: Prognostic Value of Tissue Factor (TF) in Blood t in Colorectal Cancer in Adults
Official title: Prognostic Value of Tissue Factor (TF) in Blood t in Colorectal Cancer in Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Colorectal Cancer
Keywords: colorectal cancer
Tissular factor
TF
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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 -

Primary outcomes:
measure: TNM primary colorectal tumor stage
timeFrame: Before surgery
Secondary outcomes:
measure: TF (blood levels of soluble TF)
timeFrame: 1 , 6 , 12, 18 and 24 months .5 years
measure: TF intratumoral (blood levels of TF intratumoral)
timeFrame: 1 , 6 , 12, 18 and 24 months .5 years
measure: E- selectin and CRP
timeFrame: 1 , 6 , 12, 18 and 24 months. 5 years
measure: ACE
timeFrame: 1 , 6 , 12, 18 and 24 months .5 years
measure: Interaction plate / tumor cell
timeFrame: 1 , 6 , 12, 18 and 24 months .5 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Service de Chirurgie Digestive et de transplantation Hôpital Claude HURIEZ
Study officials:
affiliation: CHRU of LILLE
name: ZERBIB Philippe, Prof
role: STUDY_DIRECTOR
References: