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"Cancersensor" Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01693861
First received: September 7, 2012
Last updated: December 6, 2016
Last verified: December 2016
  Purpose
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.

Condition
Metastatic Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official 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.

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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



Biospecimen Retention:   Samples With DNA
Urine and exfoliated oral mucosa cells

Enrollment: 16
Study Start Date: October 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients
Patients with metastatic colorectal cancer treated with chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastatic colorectal cancer treated at the Department of Medical Oncology of Paul Brousse Hospital
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693861

Locations
France
Paul Brousse Hospital
Villejuif, France, 94807
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Francis Lévi, MD PhD INSERM CNRS AP-HP Université Paris Sud
  More Information

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01693861     History of Changes
Other Study ID Numbers: C11-59
2012-A00168-35 ( Registry Identifier: IDRCB )
Study First Received: September 7, 2012
Last Updated: December 6, 2016

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Colorectal
Cancer
Metastatic
Chronotherapy
Urine
Nucleosides
Chemotherapy
Treated with chemotherapy

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 22, 2017