"Cancersensor": Circadian Rhythms

November 14, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Villejuif, France, 94800
        • Paul Brousse Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with metastatic colorectal cancer treated at the Department of Medical Oncology of Paul Brousse Hospital

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients
Patients with metastatic colorectal cancer
Healthy subjects
Age and sec-matched healthy subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 days repeated measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Francis Lévi, MD, PhD, INSERM and AP-HP and Paris South University
  • Study Director: Sandrine Dulong, PhD, Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 7, 2012

First Submitted That Met QC Criteria

September 24, 2012

First Posted (Estimated)

September 26, 2012

Study Record Updates

Last Update Posted (Estimated)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C11-42
  • 2012-A00010-43 (Registry Identifier: IDRCB)

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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