Clinical trial NCT01693835: "Cancersensor": Circadian Rhythms
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Keywords: Colorectal
Cancer
Metastatic
Healthy
Control
Circadian
Urine
Nucleosides
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2012-09-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic colorectal cancer treated at the Department of Medical Oncology of Paul Brousse Hospital

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Circadian rhythms in urinary excretion of modified nucleosides
timeFrame: 2 days repeated measures
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Paul Brousse Hospital
Study officials:
affiliation: INSERM and AP-HP and Paris South University
name: Francis Lévi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Sandrine Dulong, PhD
role: STUDY_DIRECTOR
References: