Prognostic Value of Tissue Factor (TF) in Blood t in Colorectal Cancer in Adults (TF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02304978|
Recruitment Status : Recruiting
First Posted : December 2, 2014
Last Update Posted : April 24, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Biological: Group CRC Biological: Group control||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prognostic Value of Tissue Factor (TF) in Blood t in Colorectal Cancer in Adults|
|Actual Study Start Date :||June 22, 2009|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Group CRC
patient with a colorectal cancer
Biological: Group CRC
Experimental: Group control
Control - volunteers
Biological: Group control
- TNM primary colorectal tumor stage [ Time Frame: Before surgery ]soluble blood TNM value will be determined before surgery, and compared between groups.
- 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
- 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
- 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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304978
|Contact: ZERBIB Philippe, Professeur||+00333 20 44 44 email@example.com|
|Contact: LOUNI Chanaz, CRAfirstname.lastname@example.org|
|Service de Chirurgie Digestive et de transplantation Hôpital Claude HURIEZ||Recruiting|
|Lille, France, 59037|
|Contact: ZERBIB Philippe, Prof 03 20 44 44 64 email@example.com|
|Study Director:||ZERBIB Philippe, Prof||CHRU of LILLE|