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NCT Number: NCT02304978

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

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).

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Service de Chirurgie Digestive et de transplantation Hôpital Claude HURIEZ

Lille, 59037, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Group CRC

Biological

blood samples

Group control

Biological

Blood samples

Primary outcomes

  1. TNM primary colorectal tumor stage

    Time frame: Before surgery

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

Secondary outcomes

  1. TF (blood levels of soluble TF)

    Time frame: 1 , 6 , 12, 18 and 24 months .5 years

    Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral

  2. TF intratumoral (blood levels of TF intratumoral)

    Time frame: 1 , 6 , 12, 18 and 24 months .5 years

    Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral

  3. E- selectin and CRP

    Time frame: 1 , 6 , 12, 18 and 24 months. 5 years

    Comparison - soluble TF with blood levels of other circulating proteins: E- selectin and CRP at different times of follow-up.

  4. ACE

    Time frame: 1 , 6 , 12, 18 and 24 months .5 years

    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

  5. Interaction plate / tumor cell

    Time frame: 1 , 6 , 12, 18 and 24 months .5 years

    Quantifying the interaction plate / tumor cell by measuring intraplatelet regulatory proteins and angiogenesis markers of platelet activation and plasma compare the

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: TF

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Dec 2, 2014
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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