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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.


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 : Effect of Chemotherapy on Cancerous Proliferation Based on the Dynamic Excretion of Urinary Nucleosides.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Effect of chemotherapy on urinary excretion of modified nucleosides

Outcome Description:

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

Outcome Time Frame:

17 days

Safety Issue:

No

Principal Investigator

Francis Lévi, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

INSERM CNRS AP-HP Université Paris Sud

Authority:

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

Study ID:

C11-59

NCT ID:

NCT01693861

Start Date:

September 2012

Completion Date:

August 2013

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal
  • Cancer
  • Metastatic
  • Chronotherapy
  • Urine
  • Nucleosides
  • Chemotherapy
  • Treated with chemotherapy
  • Colorectal Neoplasms

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