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"Cancersensor" Metastasis Resection

This study has been completed.
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France Identifier:
First received: September 7, 2012
Last updated: December 6, 2016
Last verified: December 2016
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.

Metastatic Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Effect of resection of metastasis on urinary excretion of modified nucleosides [ Time Frame: 10 days ]
    1 Urine sample per day 3 before and 7 after surgery Measurement of modified nucleoside concentration

Secondary Outcome Measures:
  • Identification of modified nucleosides as biomarkers for colorectal cancer [ Time Frame: 10 days ]
    Measurement of modified nucleosides in urine samples before and after metastatic resection

Biospecimen Retention:   Samples Without DNA

Enrollment: 10
Study Start Date: September 2012
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Patients with metastatic colorectal cancer scheduled for metastatic surgery
Control patients
Patients with metastatic colorectal cancer scheduled for general anesthesia without metastatic surgery


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastatic colorectal cancer treated at the Department of Medical Oncology of Paul Brousse Hospital

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.
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Please refer to this study by its identifier: NCT01693848

Paul Brousse hospital
Villejuif, France, 94800
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
  More Information

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France Identifier: NCT01693848     History of Changes
Other Study ID Numbers: C11-58
2012-A00011-42 ( Registry Identifier: IDRCB )
Study First Received: September 7, 2012
Last Updated: December 6, 2016

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
General anesthesia
Scheduled for surgery

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases processed this record on May 25, 2017