Actively Recruiting
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
Led by Institut Bergonié · Updated on 2025-10-02
332
Participants Needed
6
Research Sites
377 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
COPE is a biology driven protocol with 2 independent, multicentric, two-arm non-comparative randomized (2:1) phase II trials in 2 distinct populations: colorectal cancer patients and non-small-lung cancer patients. For each phase II trial, patient will be randomized between two arms with two patients randomized in arm A for one patient randomized in arm B: * Arm A (Experimental - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis) * Arm B (Standard - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging).
CONDITIONS
Official Title
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of colorectal cancer or non-small cell lung cancer
- Locally advanced, unresectable, or metastatic solid tumor
- Eastern Cooperative Oncology Group (ECOG) performance status less than 2
- Measurable disease with at least one lesion larger than 10 mm
- No previous systemic treatment for advanced disease
- Availability of suitable tumor tissue or lesion for biopsy
- Eligible for first-line systemic therapy
- Social security coverage complying with French law
- Voluntary signed informed consent before any study procedures
You will not qualify if you...
- Inability to swallow
- Major problems with intestinal absorption
- Previous allogeneic bone marrow transplant
- Other cancers in the last 2 years except certain treated skin or prostate cancers
- Severe or uncontrolled systemic diseases such as uncontrolled hypertension or active infections (Hepatitis B, C, HIV)
- Any condition that makes study participation undesirable or non-compliant
- Individuals deprived of liberty or under guardianship
- Pregnant or breastfeeding women
- Previous enrollment in this study
- Contraindications to first-line systemic therapy
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Centre hospitalier de la Côte Basque
Bayonne, France, 64109
Actively Recruiting
2
Clinique Tivoli-Ducos
Bordeaux, France, 33000
Actively Recruiting
3
Institut Bergonie
Bordeaux, France, 33076
Actively Recruiting
4
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33077
Actively Recruiting
5
CHRU Brest
Brest, France, 29200
Actively Recruiting
6
Polyclinique Marzet
Pau, France, 64000
Actively Recruiting
Research Team
A
Antoine ITALIANO, MD, PhD
CONTACT
S
Simone MATHOULIN-PELISSIER, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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