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OpenTrials
Completed

NCT Number: NCT01693835

"Cancersensor": Circadian Rhythms

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

  1. Circadian rhythms in urinary excretion of modified nucleosides

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 26, 2012
Registry last updated
Nov 18, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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