- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05793775
Circulating Tumor Cells and Neutrophils Count for Colorectal Metastatic Cancer
Colorectal cancer represents a major public health problem in France because of its high incidence and severe prognosis. Early stages of the disease are well know and have justified the establishment of a mass screening strategy. Unfortunately, the factors determining the progression to metastatic disease about them much harder to grasp. Various prognostic factors and predictors of treatment response have been identified and are being used but most of them are In practice, they are sometimes coarse and relatively little discriminant for patients.
It is now possible to directly quantify the amount of circulating tumor cells in peripheral blood. Quantification of circulating tumor cells beyond a threshold of 3 cells/7,5 ml has been established as a major prognostic factor, and the rapid decrease in the number of these cells under treatment is also a predictor of response for patients suffering from metastatic colorectal cancer . Furthermore, it has also been shown that the quality and importance of the systemic and peritumoral inflammatory response in carcinomas, including colorectal, played a key role in the prognosis of patients. In particular, the presence of high levels of blood neutrophils has been raised by many studies as being followed by a poorer prognosis.
However, the correlation between the presence of circulating tumor cells and high levels of neutrophils has never been studied. There is a rational to assume that this association exists, and secondly that the presence of circulating tumor cells in a proinflammatory environment represented by a high levels of blood neutrophils promotes metastasis by exerting a negative synergistic effect on the prognosis of patients.
The main objective of this pilot study is to find a correlation between the amount of circulating neutrophils and the presence of circulating tumor cells in patients with colon cancer metastatic unresectable non-pretreated. The secondary objective is to investigate whether this association results in a negative synergistic effect in terms of progression-free survival and survival to one year. This is a non-interventional study. The investigators expect the inclusion in one year of thirty patients in two centers (University Hospital Centre Antoine Lacassagne Nice) to achieve these goals.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nice, France, 06000
- Gastroentérologie et de Nutrition - CHU de Nice - Hôpital de l'Archet, 151 route de Saint-Antoine de Ginestière
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Nice, France, 06189
- Département d'Oncologie médicale - Centre Antoine Lacassagne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Age > 18 years
- Metastatic colorectal cancer
- Chemotherapy required
- Measurable scannographic target
- CT-scan < 3 weeks
- Written consent
Non-inclusion criteria :
- Personal history of invasive carcinoma
- Prior chemotherapy regimen
- Treatment with G-CSF analogs
- Corticotherapy
Exclusion criteria:
• Consent withdrawal
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Research of an association between polymorphonuclear count (number of cells per liter) and circulating tumor cells number (number of circulating tumor cells per 7,5 mililiters.
Time Frame: one time
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one time
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Research of a synergistic effect between high polymorphonuclear count and high level of circulating tumor cells on progression-free survival and overall survival. Progression will be defined according to RECIST criteria.
Time Frame: one time
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one time
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-AOI-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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