Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment
ADNCirc
1 other identifier
interventional
473
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Jul 2016
Longer than P75 for not_applicable colorectal-cancer
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedAugust 2, 2022
June 1, 2022
5.4 years
June 23, 2016
August 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
ccfDNA analysis
EXPERIMENTALThe 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
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
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Aurillac Hospital
Aurillac, 15000, France
Bergonie institute
Bordeaux, 33000, France
Bordeaux University Hospital
Bordeaux, 33000, France
Les Cèdres clinical
Brive-la-Gaillarde, 19000, France
Brive Hospital
Brivé, 19000, France
Cahors Hospital
Cahors, 46000, France
Clermont Ferrand University Hospital
Clermont-Ferrand, France
Gueret Hospital
Guéret, 23000, France
La marche clinical
Guéret, 23000, France
Limoges Hospital
Limoges, 87 042, France
Montpellier Institute
Montpellier, 34000, France
Montpellier University Hospital
Montpellier, 34000, France
Moulins Hospital
Moulins, 03000, France
Saint Antoine AP-HP
Paris, 75012, France
Perigueux clinical
Périgueux, 24000, France
Périgueux Hospital
Périgueux, 24000, France
Saint Junien Hospital
Saint-Junien, 87000, France
Sainte feyre Hospital
Sainte-Feyre, 23000, France
Vichy Hospital
Vichy, 03200, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2016
First Posted
June 27, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2021
Study Completion
July 1, 2022
Last Updated
August 2, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share
the data are anonymized