Clinical trial NCT02813928: Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment
Official title: Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: ColoRectal Cancer
Cancerology
Translational Research
ccfDNA
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 473
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: The presence of recurrences detected for patients curatively treated for a CRC stages II and III within the 3 years of follow-up.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aurillac
country: France
facility: Aurillac Hospital
city: Bordeaux
country: France
facility: Bergonie institute
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Brive-la-Gaillarde
country: France
facility: Les Cèdres clinical
city: Brive
country: France
facility: Brive Hospital
city: Cahors
country: France
facility: Cahors Hospital
city: Clermont-Ferrand
country: France
facility: Clermont Ferrand University Hospital
city: Guéret
country: France
facility: Gueret Hospital
city: Guéret
country: France
facility: La marche clinical
city: Limoges
country: France
facility: Limoges Hospital
city: Montpellier
country: France
facility: Montpellier Institute
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Moulins
country: France
facility: Moulins Hospital
city: Paris
country: France
facility: Saint Antoine AP-HP
city: Périgueux
country: France
facility: Perigueux clinical
city: Périgueux
country: France
facility: Périgueux Hospital
city: Saint-Junien
country: France
facility: Saint Junien Hospital
city: Sainte feyre
country: France
facility: Sainte feyre Hospital
city: Vichy
country: France
facility: Vichy Hospital
Study officials:
References: