Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment
NCT ID: NCT02813928
Last Updated: 2022-08-02
Study Results
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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COMPLETED
NA
473 participants
INTERVENTIONAL
2016-07-31
2022-07-31
Brief Summary
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Tubes for ccfDNA analysis will be taken during medical examination at the same time of the CEA dosage (if it was not made before the consultation). Cryotubes of plasma will be sent for analysis in the laboratory INSERM (National Health Institute) of Montpellier and the remaining plasma will be kept in biological collection.
Patients will have a consultation of follow-up every 3-4 months during which the dosage of CEA and ccfDNA will be realized as well as a medical examination, a general examination (weight, size, and blood pressure), an evaluation of the indices of performance status and a nutritional evaluation in case of loss of weight.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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ccfDNA analysis
The level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance.
ccfDNA analysis
The level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance
Interventions
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ccfDNA analysis
The level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance
Eligibility Criteria
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Inclusion Criteria
* Primary diagnosis of stages II and III CRC:
* is already operated and histological proven (biopsy at least)
* is patient that must be operated: curative treatment for stages II and III CRC
* Patient benefiting from a program personalized by care
* Written informed consent
Exclusion Criteria
* Patient with indication or with palliative treatment
* Pregnant or nursing patients
* Known pregnancy
* Difficulties to understand the protocol
* Patients under protection measure (guardianship, curatorship, protection of justice)
18 Years
ALL
No
Sponsors
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University Hospital, Limoges
OTHER
Responsible Party
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Locations
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Aurillac Hospital
Aurillac, , France
Bergonie institute
Bordeaux, , France
Bordeaux University Hospital
Bordeaux, , France
Les Cèdres clinical
Brive-la-Gaillarde, , France
Brive Hospital
Brivé, , France
Cahors Hospital
Cahors, , France
Clermont Ferrand University Hospital
Clermont-Ferrand, , France
Gueret Hospital
Guéret, , France
La marche clinical
Guéret, , France
Limoges Hospital
Limoges, , France
Montpellier Institute
Montpellier, , France
Montpellier University Hospital
Montpellier, , France
Moulins Hospital
Moulins, , France
Saint Antoine AP-HP
Paris, , France
Perigueux clinical
Périgueux, , France
Périgueux Hospital
Périgueux, , France
Saint Junien Hospital
Saint-Junien, , France
Sainte feyre Hospital
Sainte-Feyre, , France
Vichy Hospital
Vichy, , France
Countries
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Other Identifiers
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I15031
Identifier Type: -
Identifier Source: org_study_id
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