Cancersensor Metastasis Resection

Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring, of Cancer Therapy: Impact of Surgical Resection of Metastasis on Urinary Excretion of Modified Nucleosides.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01693848

Enrollment

Registered

2012-09-26

Start date

2012-09-30

Completion date

2014-11-30

Last updated

2016-12-07

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, Control, Urine, Nucleosides, Surgery, General anesthesia, Scheduled for surgery

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

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

* 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 resection of metastasis on urinary excretion of modified nucleosides	10 days	1 Urine sample per day 3 before and 7 after surgery Measurement of modified nucleoside concentration

Secondary

Measure	Time frame	Description
Identification of modified nucleosides as biomarkers for colorectal cancer	10 days	Measurement of modified nucleosides in urine samples before and after metastatic resection

Countries

France

Outcome results