Cancersensor: Circadian Rhythms

Study Overview
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Brief Summary
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Observational, non randomized study aimed at measuring the circadian rhythms in the urinary concentrations of physiological modified nucleosides in 30 patients with metastatic colorectal cancer and in 30 age and sex-matched healthy subjects.

Official Title
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Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring of Cancer Therapy : the Circadian Rhythms of Urinary Excretion of Modified Nucleosides.

Conditions
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Metastatic Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for patients: Histologically-confirmed metastatic colorectal cancer; 0 to 3 prior chemotherapy lines; Signed informed consent; Good understanding of the protocol and of the follow-up; Estimated life expectancy exceeding 3 months; At least one measurable metastatic lesion (RECIST criteria); Performance Status (WHO) of 0 to 2; Good haematological, hepatic and renal functions. Inclusion criteria for healthy subject Age ≥ 18 ans Signed informed consent; Good understanding of the protocol and of the follow-up; Good haematological, hepatic and renal functions. Test HIV and B and C hepatitis negative test No chronic or acute diseases Exclusion Criteria for patients: Poor performance status (>2); Poor haematological, hepatic or renal functions; Uncontrolled chronic disease; Serious unhealed wound, ulcer or fracture within the previous month; Clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion; Pregnancy or breast-feeding during the previous month; Transmeridian trip of more than 4 time zones within the prior 2 weeks; Person with legal restriction to participate into clinical research, according to the current law in France. Exclusion criteria for healthy subject: Poor haematological, hepatic or renal functions; Uncontrolled chronic disease; Serious unhealed wound, ulcer or fracture within the previous month; Clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion; Pregnancy or breast-feeding during the previous month; Transmeridian trip of more than 4 time zones within the prior 2 weeks; Person with legal restriction to participate into clinical research, according to the current law in France.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with metastatic colorectal cancer | |
| Healthy subjects<br>Age and sec-matched healthy subjects | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circadian rhythms in urinary excretion of modified nucleosides | 10 Urine samples over 2 days Measurement of modified nucleosides, cortisol and 6-sulfatoxymelatonin concentration 1 saliva sample Measurement of Clock genes polymorphisms expression | 2 days repeated measures | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal, Cancer, Metastatic, Healthy, Control, Circadian, Urine, Nucleosides