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Completed

NCT Number: NCT01693861

"Cancersensor" Chemotherapy

Observational, non randomized study aimed at measuring the effect of chemotherapy in the urinary concentrations of physiological modified nucleosides in 30 patients with metastatic colorectal cancer.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Paul Brousse Hospital

Villejuif, 94807, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • More than 2 surgical resections of metastases from colorectal cancer;
  • 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.

Treatment and study plan

Primary outcomes

  1. Effect of chemotherapy on urinary excretion of modified nucleosides

    Time frame: 17 days

    1 urine sample per day 3 days before and 14 days after beginning of chemotherapy Measurement of modified nucleosides, cortisol and 6-sulfatoxymelatonin concentration

    1 saliva sample : Measurement of Clock genes polymorphisms expression

Other outcomes

  1. Identification of modified nucleosides as biomarkers for colorectal cancer

    Time frame: 17 days

    Measurement of modified nucleosides, cortisol and 6-sulfatoxymelatonin concentration in urine samples before and after chemotherapy

    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 : Effect of Chemotherapy on Cancerous Proliferation Based on the Dynamic Excretion of Urinary Nucleosides.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 26, 2012
Registry last updated
Dec 10, 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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