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"Cancersensor" Metastasis Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01693848
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : December 7, 2016
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.

Condition or disease
Metastatic Colorectal Cancer

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Study Type : Observational
Actual Enrollment : 10 participants
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.
Study Start Date : September 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Patients with metastatic colorectal cancer scheduled for metastatic surgery
Control patients
Patients with metastatic colorectal cancer scheduled for general anesthesia without metastatic surgery

Primary Outcome Measures :
  1. 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 :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01693848

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Paul Brousse hospital
Villejuif, France, 94800
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France Identifier: NCT01693848    
Other Study ID Numbers: C11-58
2012-A00011-42 ( Registry Identifier: IDRCB )
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
General anesthesia
Scheduled for surgery
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes