Cancersensor Chemotherapy

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01693861

Enrollment

Registered

2012-09-26

Start date

2012-10-31

Completion date

2015-02-28

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Keywords

Colorectal, Cancer, Metastatic, Chronotherapy, Urine, Nucleosides, Chemotherapy, Treated with chemotherapy

Brief summary

Observational, non randomized study aimed at measuring the effect of chemotherapy in the urinary concentrations of physiological modified nucleosides in 30 patients with metastatic colorectal cancer.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Effect of chemotherapy on urinary excretion of modified nucleosides	17 days	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

Other

Measure	Time frame	Description
Identification of modified nucleosides as biomarkers for colorectal cancer	17 days	Measurement of modified nucleosides, cortisol and 6-sulfatoxymelatonin concentration in urine samples before and after chemotherapy 1 saliva sample Measurement of Clock genes polymorphisms expression

Countries

France

Outcome results