Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment

NCT ID: NCT02813928

Last Updated: 2022-08-02

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

Clinical Phase

NA

Total Enrollment

473 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2022-07-31

Brief Summary

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Inspite of curative treatment 30-50% patients with ColoRectal Cancer (CRC) develop tumor relapse during the first 3 years after treatment of the primary tumor. Treatment of relapses is based on surgical resection, when possible, chemotherapy and targeted therapies. To detect recurrences or metastases, a surveillance strategy is recommended for patients able to withstand complementary treatment during a five-year period. Over this period, the probability of one false-positive result is 87%. Considering that less than 10% of recurrent patients are suitable for potentially curative treatment and that more intensive programs enable an increase of the overall rate of curative resection but do not result in reduced mortality, less time and cost-consuming, tailored follow-up is necessary. 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.

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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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.

Group Type EXPERIMENTAL

ccfDNA analysis

Intervention Type GENETIC

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

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* 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 already treated for stages II and III CRC and in surveillance
* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aurillac Hospital

Aurillac, , France

Site Status

Bergonie institute

Bordeaux, , France

Site Status

Bordeaux University Hospital

Bordeaux, , France

Site Status

Les Cèdres clinical

Brive-la-Gaillarde, , France

Site Status

Brive Hospital

Brivé, , France

Site Status

Cahors Hospital

Cahors, , France

Site Status

Clermont Ferrand University Hospital

Clermont-Ferrand, , France

Site Status

Gueret Hospital

Guéret, , France

Site Status

La marche clinical

Guéret, , France

Site Status

Limoges Hospital

Limoges, , France

Site Status

Montpellier Institute

Montpellier, , France

Site Status

Montpellier University Hospital

Montpellier, , France

Site Status

Moulins Hospital

Moulins, , France

Site Status

Saint Antoine AP-HP

Paris, , France

Site Status

Perigueux clinical

Périgueux, , France

Site Status

Périgueux Hospital

Périgueux, , France

Site Status

Saint Junien Hospital

Saint-Junien, , France

Site Status

Sainte feyre Hospital

Sainte-Feyre, , France

Site Status

Vichy Hospital

Vichy, , France

Site Status

Countries

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France

Other Identifiers

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I15031

Identifier Type: -

Identifier Source: org_study_id

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