Colorectal CancerEarly Phase 1TFNCT02304978
Prognostic Value of Tissue Factor (TF) in Blood t in Colorectal Cancer in Adults
A Early Phase 1 study testing Group CRC in people with Colorectal Cancer, run by University Hospital, Lille at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Group CRC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2009to 26 May 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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-
Who cannot join
- 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
Show all 14Show fewer
- 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 -
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Digestive et de transplantation Hôpital Claude HURIEZ
Lille, 59037
About this study
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.
Read more
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).
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Group CRC, Group control
- Keywords
- colorectal cancer, Tissular factor, TF
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group CRCBiological
blood samples
Group controlBiological
Blood samples
| Study group | Role | What they receive |
|---|---|---|
| Group CRC | Experimental | patient with a colorectal cancer Receives: Biological: Group CRC |
| Group control | Experimental | Control - volunteers Receives: Biological: Group control |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNM primary colorectal tumor stage
soluble blood TNM value will be determined before surgery, and compared between groups.
Measured: Before surgery
Secondary outcomes (5)
TF (blood levels of soluble TF)
Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral
Measured: 1 , 6 , 12, 18 and 24 months .5 years
TF intratumoral (blood levels of TF intratumoral)
Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral
Measured: 1 , 6 , 12, 18 and 24 months .5 years
E- selectin and CRP
Comparison - soluble TF with blood levels of other circulating proteins: E- selectin and CRP at different times of follow-up.
Measured: 1 , 6 , 12, 18 and 24 months. 5 years
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
Measured: 1 , 6 , 12, 18 and 24 months .5 years
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
Measured: 1 , 6 , 12, 18 and 24 months .5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study start22 Jun 2009
- Primary completion26 May 2015
- Study completion26 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ZERBIB Philippe, Prof, Study director, CHRU of LILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304978
- Sponsor's protocol ID
- 2008-09/0908
- Other IDs
- 2009-A00264-53
- Acronym
- TF
- Status last verified
- Dec 2025
- First submitted
- 24 Jun 2014
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Tissue Factor (TF) in Blood t in Colorectal Cancer in Adults
- ClinicalTrials.gov ID
- NCT02304978
- Acronym / sponsor ID
- TF / 2008-09/0908
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, Tissular factor, TF
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 22 Jun 2009 (actual)
- Primary completion
- 26 May 2015 (actual)
- Study completion
- 26 May 2015 (actual)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group CRC | Experimental | Biological: Group CRCpatient with a colorectal cancer |
| Group control | Experimental | Biological: Group controlControl - volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients, adults, holders of CRC with or without MH in whom surgical resection HEALING is planned .
- 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-
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group CRCblood samples | Biological | Group CRC |
| Group controlBlood samples | Biological | Group control |
Primary outcome
TNM primary colorectal tumor stage
Time frame: Before surgery
soluble blood TNM value will be determined before surgery, and compared between groups.
5 secondary outcomes
TF (blood levels of soluble TF)
Time frame: 1 , 6 , 12, 18 and 24 months .5 years
TF intratumoral (blood levels of TF intratumoral)
Time frame: 1 , 6 , 12, 18 and 24 months .5 years
E- selectin and CRP
Time frame: 1 , 6 , 12, 18 and 24 months. 5 years
ACE
Time frame: 1 , 6 , 12, 18 and 24 months .5 years
Interaction plate / tumor cell
Time frame: 1 , 6 , 12, 18 and 24 months .5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ZERBIB Philippe, Prof study director
CHRU of LILLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Group CRC in people with Colorectal Cancer, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TNM primary colorectal tumor stage (time frame: Before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.