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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
Group CRC
Group control
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring colorectal cancer, Tissular factor, TF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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 -

Sites / Locations

  • Service de Chirurgie Digestive et de transplantation Hôpital Claude HURIEZRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group CRC

Group control

Arm Description

patient with a colorectal cancer

Control - volunteers

Outcomes

Primary Outcome Measures

TNM primary colorectal tumor stage
soluble blood TNM value will be determined before surgery, and compared between groups.

Secondary Outcome Measures

TF (blood levels of soluble TF)
Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral
TF intratumoral (blood levels of TF intratumoral)
Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral
E- selectin and CRP
Comparison - soluble TF with blood levels of other circulating proteins: E- selectin and CRP at different times of follow-up.
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
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

Full Information

First Posted
June 24, 2014
Last Updated
June 25, 2019
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT02304978
Brief Title
Prognostic Value of Tissue Factor (TF) in Blood t in Colorectal Cancer in Adults
Acronym
TF
Official Title
Prognostic Value of Tissue Factor (TF) in Blood t in Colorectal Cancer in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 22, 2009 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, Tissular factor, TF

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group CRC
Arm Type
Experimental
Arm Description
patient with a colorectal cancer
Arm Title
Group control
Arm Type
Experimental
Arm Description
Control - volunteers
Intervention Type
Biological
Intervention Name(s)
Group CRC
Intervention Description
blood samples
Intervention Type
Biological
Intervention Name(s)
Group control
Intervention Description
Blood samples
Primary Outcome Measure Information:
Title
TNM primary colorectal tumor stage
Description
soluble blood TNM value will be determined before surgery, and compared between groups.
Time Frame
Before surgery
Secondary Outcome Measure Information:
Title
TF (blood levels of soluble TF)
Description
Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral
Time Frame
1 , 6 , 12, 18 and 24 months .5 years
Title
TF intratumoral (blood levels of TF intratumoral)
Description
Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral
Time Frame
1 , 6 , 12, 18 and 24 months .5 years
Title
E- selectin and CRP
Description
Comparison - soluble TF with blood levels of other circulating proteins: E- selectin and CRP at different times of follow-up.
Time Frame
1 , 6 , 12, 18 and 24 months. 5 years
Title
ACE
Description
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
Time Frame
1 , 6 , 12, 18 and 24 months .5 years
Title
Interaction plate / tumor cell
Description
Quantifying the interaction plate / tumor cell by measuring intraplatelet regulatory proteins and angiogenesis markers of platelet activation and plasma compare the
Time Frame
1 , 6 , 12, 18 and 24 months .5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ZERBIB Philippe, Professeur
Phone
+00333 20 44 44 64
Email
p-zerbib@chru-lille.fr
First Name & Middle Initial & Last Name or Official Title & Degree
LOUNI Chanaz, CRA
Phone
+0033320414445
Email
chanaz.louni@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZERBIB Philippe, Prof
Organizational Affiliation
CHRU of LILLE
Official's Role
Study Director
Facility Information:
Facility Name
Service de Chirurgie Digestive et de transplantation Hôpital Claude HURIEZ
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ZERBIB Philippe, Prof
Phone
03 20 44 44 64
Email
p-zerbib@chru-lille.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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