"Cancersensor": Circadian Rhythms

Metastatic Colorectal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693835
• Other study ID #: C11-42
• Secondary ID: 2012-A00010-43
• Status: Completed
• Phase: N/A
• First received: September 7, 2012
• Last updated: December 6, 2016
• Start date: August 2012
• Est. completion date: June 2014

Study information

• Verified date: December 2016
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Locations

Country	Name	City	State
France	Paul Brousse Hospital	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circadian rhythms in urinary excretion of modified nucleosides	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	No