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NCT Number: 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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Département d'Oncologie médicale - Centre Antoine Lacassagne, Nice, France

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Who can participate

Healthy volunteers accepted: No

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

  • 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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 31, 2023
Registry last updated
Mar 31, 2023

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

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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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