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Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring of Cancer Therapy : the Circadian Rhythms of Urinary Excretion of Modified Nucleosides.


N/A
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information

Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring of Cancer Therapy : the Circadian Rhythms of Urinary Excretion of Modified Nucleosides.

Inclusion 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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Circadian rhythms in urinary excretion of modified nucleosides

Outcome Description:

10 Urine samples over 2 days Measurement of modified nucleosides, cortisol and 6-sulfatoxymelatonin concentration 1 saliva sample Measurement of Clock genes polymorphisms expression

Outcome Time Frame:

2 days repeated measures

Safety Issue:

No

Principal Investigator

Francis Lévi, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

INSERM and AP-HP and Paris South University

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

C11-42

NCT ID:

NCT01693835

Start Date:

July 2012

Completion Date:

August 2013

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal
  • Cancer
  • Metastatic
  • Healthy
  • Control
  • Circadian
  • Urine
  • Nucleosides
  • Colorectal Neoplasms

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