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Active, not recruiting Not applicable

Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study

NCT04258137 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2020-09-04
Last updated
2026-07-24

Condition(s) studied

Colorectal CancerNon Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Liquid biopsy

Liquid biopsy: Liquid biopsy will be performed at cycle 1 day 1 and cycle 2 day of each line of systemic treatment, at each tumor evaluation by Imaging and at confirmation of progression

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years, 2. Histology: colorectal cancer, non-small cell lung cancer, 3. Locally advanced/unresectable and/or metastatic solid tumor, 4. Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Appendix 1), 5. Measurable disease according to RECIST 1.1 (lesion in previously irradiated filed can be considered as measurable if progressive at inclusion according to RECIST v1.1). At least one site of disease must be uni-dimensionally \> 10 mm, 6. No previous systemic treatment for advanced disease, 7. Availability of suitable paraffin embedded (FFPE) archive tumor material or at least one target lesion that can be biopsied for research purpose, 8. Eligible to first-line systemic therapy, 9. Patient with a social security in compliance with the French law, 10. Voluntary signed and dated written informed consent prior to any study specific procedure. Exclusion Criteria: 1. Inability to swallow, 2. Major problem with intestinal absorption, 3. Previous allogeneic bone marrow transplant, 4. Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer, 5. Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV), 6. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol, 7. Individuals deprived of liberty or placed under guardianship, 8. Pregnant or breast feeding women, 9. Previous enrolment in the present study, 10. Any contraindication to first-line systemic therapy.

Primary outcome measure(s)

  • Assessment of cancer outcome in terms of overall survival (2 distincts population) — 18 months
    Overall Survival (OS) is defined as the time interval between the date of randomization and the date of death (of any cause).

Trial sites (6)

FacilityCityRegionStatus
Centre hospitalier de la Côte Basque Bayonne France
Clinique Tivoli-Ducos Bordeaux France
Institut Bergonie Bordeaux France
Polyclinique Bordeaux Nord Aquitaine Bordeaux France
CHRU Brest Brest France
Polyclinique Marzet Pau France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04258137 on ClinicalTrials.gov ↗ ← All trials in France