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New treatment option for Colorectal Cancer
Official title Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
ClinicalTrials.gov ID: NCT04258137
What this study is testing
What is Liquid biopsy?
Liquid biopsy is an investigational medicine, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years,
- Histology: colorectal cancer, non-small cell lung cancer,
- Locally advanced/unresectable and/or metastatic solid tumor,
- Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Appendix 1),
- Measurable disease according to RECIST 1.1 (lesion in previously irradiated filed can be considered as measurable if progressive at inclusion...
You likely can't join if
- Inability to swallow,
- Major problem with intestinal absorption,
- Previous allogeneic bone marrow transplant,
- Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately...
- Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV),
- Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize...
See the full eligibility criteria
- Age ≥ 18 years,
- Histology: colorectal cancer, non-small cell lung cancer,
- Locally advanced/unresectable and/or metastatic solid tumor,
- Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Appendix 1),
- 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...
- No previous systemic treatment for advanced disease,
- Availability of suitable paraffin embedded (FFPE) archive tumor material or at least one target lesion that can be biopsied for research purpose,
- Eligible to first-line systemic therapy,
- Patient with a social security in compliance with the French law,
- Voluntary signed and dated written informed consent prior to any study specific procedure.
- Inability to swallow,
- Major problem with intestinal absorption,
- Previous allogeneic bone marrow transplant,
- 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...
- Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV),
- 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,
- Individuals deprived of liberty or placed under guardianship,
- Pregnant or breast feeding women,
- Previous enrolment in the present study,
- Any contraindication to first-line systemic therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Bayonne, France
- Bordeaux, France
- Brest, France
- Pau, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bayonne, France; Bordeaux, France; Brest, France; Pau, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.