"Cancersensor" Metastasis Resection

NCT ID: NCT01693848

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Keywords

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Colorectal Cancer Metastatic Control Urine Nucleosides Surgery General anesthesia Scheduled for surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients with metastatic colorectal cancer scheduled for metastatic surgery

No interventions assigned to this group

Control patients

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Paul Brousse hospital

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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2012-A00011-42

Identifier Type: REGISTRY

Identifier Source: secondary_id

C11-58

Identifier Type: -

Identifier Source: org_study_id