Cancersensor: Circadian Rhythms

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01693835

Enrollment

Registered

2012-09-26

Start date

2012-08-31

Completion date

2014-06-30

Last updated

2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Keywords

Colorectal, Cancer, Metastatic, Healthy, Control, Circadian, Urine, Nucleosides

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

France

Outcome results