"Cancersensor" Metastasis Resection

Institut National de la Santé Et de la Recherche Médicale, France10 enrolled

Overview

Observational, non randomized study aimed at measuring the effect of surgical resection of metastasis in the urinary concentrations of physiological modified nucleosides in 45 patients with metastatic colorectal cancer.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Metastatic Colorectal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: * 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.

Locations (1)

Paul Brousse hospital

Villejuif, France

Outcomes

Primary Outcomes

Effect of resection of metastasis on urinary excretion of modified nucleosides

1 Urine sample per day 3 before and 7 after surgery Measurement of modified nucleoside concentration

Time frame: 10 days

Secondary Outcomes

Identification of modified nucleosides as biomarkers for colorectal cancer

Measurement of modified nucleosides in urine samples before and after metastatic resection

Time frame: 10 days

Data from ClinicalTrials.gov

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