"Cancersensor": Circadian Rhythms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01693835
First received: September 7, 2012
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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.


Condition
Metastatic Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring of Cancer Therapy : the Circadian Rhythms of Urinary Excretion of Modified 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:
  • Circadian rhythms in urinary excretion of modified nucleosides [ Time Frame: 2 days repeated measures ] [ Designated as safety issue: No ]

    10 Urine samples over 2 days Measurement of modified nucleosides, cortisol and 6-sulfatoxymelatonin concentration

    1 saliva sample Measurement of Clock genes polymorphisms expression



Biospecimen Retention:   Samples With DNA

Saliva (exfoliated oral mucosa cells) and urine


Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients
Patients with metastatic colorectal cancer
Healthy subjects
Age and sec-matched healthy subjects

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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.
  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: NCT01693835

Contacts
Contact: Francis Lévi, MD, PhD +33149583481 francis.levi@inserm.fr
Contact: Sandrine Dulong, PhD +33149583479 sandrine.dulong@inserm.fr

Locations
France
Paul Brousse Hospital Recruiting
Villejuif, France, 94800
Contact: Francis Lévi, MD, PhD    +33149583481    francis.levi@inserm.fr   
Contact: Abdoulaye Karaboue, MD    +33145593553    abdoulaye.karaboue@inserm.fr   
Principal Investigator: Francis Lévi, MD, PhD         
Sub-Investigator: Pasquale F Innominato, MD, PhD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01693835     History of Changes
Other Study ID Numbers: C11-42, 2012-A00010-43
Study First Received: September 7, 2012
Last Updated: September 24, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Colorectal
Cancer
Metastatic
Healthy
Control
Circadian
Urine
Nucleosides

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

ClinicalTrials.gov processed this record on October 29, 2014