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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ccfDNA analysis
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring ColoRectal Cancer, Cancerology, Translational Research, ccfDNA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Aurillac Hospital
  • Bergonie institute
  • Bordeaux University Hospital
  • Les Cèdres clinical
  • Brive Hospital
  • Cahors Hospital
  • Clermont Ferrand University Hospital
  • Gueret Hospital
  • La marche clinical
  • Limoges Hospital
  • Montpellier Institute
  • Montpellier University Hospital
  • Moulins Hospital
  • Saint Antoine AP-HP
  • Perigueux clinical
  • Périgueux Hospital
  • Saint Junien Hospital
  • Sainte feyre Hospital
  • Vichy Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ccfDNA analysis

Arm Description

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.

Outcomes

Primary Outcome Measures

The presence of recurrences detected for patients curatively treated for a CRC stages II and III within the 3 years of follow-up.

Secondary Outcome Measures

Full Information

First Posted
June 23, 2016
Last Updated
August 1, 2022
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT02813928
Brief Title
Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment
Acronym
ADNCirc
Official Title
Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
July 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
ColoRectal Cancer, Cancerology, Translational Research, ccfDNA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
473 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ccfDNA analysis
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
ccfDNA analysis
Intervention Description
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
Primary Outcome Measure Information:
Title
The presence of recurrences detected for patients curatively treated for a CRC stages II and III within the 3 years of follow-up.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Aurillac Hospital
City
Aurillac
ZIP/Postal Code
15000
Country
France
Facility Name
Bergonie institute
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Bordeaux University Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Les Cèdres clinical
City
Brive-la-Gaillarde
ZIP/Postal Code
19000
Country
France
Facility Name
Brive Hospital
City
Brive
ZIP/Postal Code
19000
Country
France
Facility Name
Cahors Hospital
City
Cahors
ZIP/Postal Code
46000
Country
France
Facility Name
Clermont Ferrand University Hospital
City
Clermont-Ferrand
Country
France
Facility Name
Gueret Hospital
City
Guéret
ZIP/Postal Code
23000
Country
France
Facility Name
La marche clinical
City
Guéret
ZIP/Postal Code
23000
Country
France
Facility Name
Limoges Hospital
City
Limoges
ZIP/Postal Code
87 042
Country
France
Facility Name
Montpellier Institute
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Moulins Hospital
City
Moulins
ZIP/Postal Code
03000
Country
France
Facility Name
Saint Antoine AP-HP
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Perigueux clinical
City
Périgueux
ZIP/Postal Code
24000
Country
France
Facility Name
Périgueux Hospital
City
Périgueux
ZIP/Postal Code
24000
Country
France
Facility Name
Saint Junien Hospital
City
Saint-Junien
ZIP/Postal Code
87000
Country
France
Facility Name
Sainte feyre Hospital
City
Sainte feyre
ZIP/Postal Code
23000
Country
France
Facility Name
Vichy Hospital
City
Vichy
ZIP/Postal Code
03200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
the data are anonymized

Learn more about this trial

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

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