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

Colorectal Cancer Clinical Trial

— ADNCirc  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813928
• Other study ID #: I15031
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 2022

Study information

• Verified date: June 2022
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: July 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Genetic:
• 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

Locations

Country	Name	City	State
France	Aurillac Hospital	Aurillac
France	Bergonie institute	Bordeaux
France	Bordeaux University Hospital	Bordeaux
France	Brive Hospital	Brive
France	Les Cèdres clinical	Brive-la-Gaillarde
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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence of recurrences detected for patients curatively treated for a CRC stages II and III within the 3 years of follow-up.		3 years