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

Colorectal Cancer Clinical Trial

— TF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02304978
• Other study ID #: 2008-09/0908
• Secondary ID: 2009-A00264-53
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 22, 2009
• Est. completion date: June 2020

Study information

• Verified date: June 2019
• Source: University Hospital, Lille
• Contact: ZERBIB Philippe, Professeur
• Phone: +00333 20 44 44 64
• Email: p-zerbib[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Biological:
• Group CRC
blood samples
• Group control
Blood samples

Locations

Country	Name	City	State
France	Service de Chirurgie Digestive et de transplantation Hôpital Claude HURIEZ	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TNM primary colorectal tumor stage	soluble blood TNM value will be determined before surgery, and compared between groups.	Before surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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