Unresectable Locally Advanced Colorectal CancerCOPERNICNCT05487248
A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients
A study testing Blood Sample Collection in people with Unresectable Locally Advanced Colorectal Cancer and Metastatic Colorectal Cancer, run by Jules Bordet Institute at 12 sites in 2 countries.
Trial summary
COPERNIC is an international, multicentre, single-arm study. Chemo-refractory mCRC subjects who meet all eligibility criteria will be treated with standard systemic chemotherapy (the decision about the treatment regimen being made by the treating physician) and undergo tumour assessment by standard imaging (either CT… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Locally Advanced Colorectal Cancer, Metastatic Colorectal Cancer, Candidate for Third-line or Subsequent Lines of Therapy
- What is being tested?
- Blood Sample Collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 12 Oct 2023to 24 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Male or female
- ECOG performance status ≤2
- Must have histologically or cytologically verified colorectal cancer adenocarcinoma
- Inoperable locally advanced or metastatic disease
- Presence of measurable disease (by RECIST criteria version 1.1) on baseline CT scan of the thorax/abdomen/pelvis or CT scan of the thorax and MRI of the abdomen/pelvis
Show all 15Show fewer
- At least two prior systemic treatments for advanced/metastatic colorectal cancer including oxaliplatin and irinotecan-based therapy (adjuvant or neoadjuvant systemic chemotherapy will be considered if tumour progression was documented within 6 month of the last chemotherapy dose)
- Candidate for standard third-line or subsequent lines of therapy as per decision of the treating physician
- Life expectancy of at least 3 months
- Women of childbearing potential must have a negative serum pregnancy test done within 28 days prior to enrolment.
- Effective contraception is in place for women of childbearing potential.
- Completion of all necessary screening procedures within 28 days prior to enrolment.
- Availability of archived tumour tissue
- Signed Informed Consent form (ICF) obtained prior to any study related procedure.
- Affiliated to the French Social Security System
Who cannot join
- Tumours other than colorectal cancer
- Histologies other than adenocarcinoma
- Any baseline medical condition that would contraindicate the use of systemic chemotherapy or may preclude the regular administration of the same
- Any psychiatric condition that would prohibit the understanding or rendering of informed consent
- Other invasive malignancy within 3 years except for non-invasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured
- Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.
- Pregnant and/ or lactating women
- Vulnerable persons according to the article L.1121-6 of the Public Health Code, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the Public Health Code.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
France7 sites
Centre Georges François Leclerc
Dijon
Hopital Franco-Britannique - Fondation Cognacq-Jay
Levallois-Perret, 92300
Hopital privé Jean Mermoz
Lyon
Hopital St-Louis
Paris
CHU Poitiers
Poitiers
ICO Saint-Herblain
Saint-Herblain
ICANS Strasbourg
Strasbourg
Belgium5 sites
Institut Jules Bordet
Anderlecht, 1070
UZ Antwerpen
Antwerp
CHIREC Delta
Brussels
CHU Ambroise Pare
Mons, 7000
Cliniques Universitaires Saint Luc
Woluwe-Saint-Lambert, 1200
About this study
COPERNIC is an international, multicentre, single-arm study. Chemo-refractory mCRC subjects who meet all eligibility criteria will be treated with standard systemic chemotherapy (the decision about the treatment regimen being made by the treating physician) and undergo tumour assessment by standard imaging (either CT scan or MRI scan) at baseline and every 8 or 12 weeks until evidence of tumour progression. Response to treatment will be assessed by the local investigators according to the RECIST criteria version 1.1. Blinded, independent central review of the imaging scan will be carried out, this having no impact on treatment decisions thatwhich will remain the prerogative of the treating physician.
Serial blood samples from study subjects will be collected at pre-defined time points for ctDNA testing. Also, archived tumour tissue from each subject will be collected. Prospective and retrospective ctDNA analyses on blood samples will be carried out, and dynamics of ctDNA will be correlated with treatment outcomes prognosis.
Read the detailed description
COPERNIC is an international, multicentre, single-arm study. Chemo-refractory mCRC subjects who meet all eligibility criteria will be treated with standard systemic chemotherapy (the decision about the treatment regimen being made by the treating physician) and undergo tumour assessment by standard imaging (either CT scan or MRI scan) at baseline and every 8 or 12 weeks until evidence of tumour progression. Response to treatment will be assessed by the local investigators according to the RECIST criteria version 1.1. Blinded, independent central review of the imaging scan will be carried out, this having no impact on treatment decisions which will remain the prerogative of the treating physician.
Serial blood samples from study subjects will be collected at pre-defined time points for ctDNA testing. Also, archived tumour tissue from each subject will be collected. Prospective and retrospective ctDNA analyses on blood samples will be carried out, and dynamics of ctDNA will be correlated with prognosis.
Two ctDNA assays will be used in this study:
- FoundationOne Liquid CDx (F1LCDx) for comprehensive genomic profile (CGP) assessment
- F1Monitor for monitoring purpose
For subjects receiving treatments with a 2- or 4-weekly schedule, blood and plasma samples for ctDNA testing will be collected at the following timepoints:
Blood :
- Before treatment start (day 1)
- 2 weeks after treatment start (day 15)
Plasma :
- Before the treatment start (day 1)
- 4 weeks after treatment start (day 29)
- 8 or 12 weeks after treatment start and every 8 or 12 weeks thereafter (i.e. at the same time of each imaging tumour assessment) until evidence of progressive disease by RECIST 1.1
For subjects receiving treatments with a 3-weekly schedule, blood and plasma samples for ctDNA testing will be collected at the following timepoints:
Blood :
- Before treatment start (day 1)
- 3 weeks after treatment start (day 22)
Plasma :
- Before treatment start (day 1)
- 6 weeks after treatment start (day 43)
- 8 or 12 weeks after treatment start and every 8 or 12 weeks thereafter (i.e. at the same time of each imaging tumour assessment) until evidence of progressive disease by RECIST 1.1 ctDNA analyses will be done in a centralised laboratory (Foundation Medicine Inc). Full report of the ctDNA analysis will be provided to the study team to allow correlation with clinical data and exploratory analyses. The results of the ctDNA analysis will not be communicated to the treating physician (with the only exception of the analysis by F1CDx on tumour tissue at screening) and therefore will not have any impact on treatment decision (i.e., all study subjects will be treated according to standard practice).
- Conditions
- Unresectable Locally Advanced Colorectal Cancer, Metastatic Colorectal Cancer, Candidate for Third-line or Subsequent Lines of Therapy
- Being tested
- Blood Sample Collection
- Keywords
- colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sample CollectionOther
For subjects receiving treatments with a 2- or 4-weekly schedule, samples for ctDNA testing will be collected at the following timepoints:
Blood :
- Before treatment start (day 1)
- 2 weeks after treatment start (day 15)
Plasma :
- Before the treatment start (day 1)
- 4 weeks after treatment start (day 29)
- 8 or 12 weeks after treatment start and every 8 or 12 weeks thereafter (i.e. at the same time of each imaging tumour assessment) until evidence of progressive disease by RECIST 1.1
For subjects receiving treatments with a 3-weekly schedule, samples for ctDNA testing will be collected at the following timepoints:
Blood :
- Before treatment start (day 1)
- 3 weeks after treatment start (day 22)
Plasma :
- Before treatment start (day 1)
- 6 weeks after treatment start (day 43)
- 8 or 12 weeks after treatment start and every 8 or 12 weeks thereafter (i.e. at the same time of each imaging tumour assessment) until evidence of progressive disease by RECIST 1.1
| Study group | Role | What they receive |
|---|---|---|
| Unresectable locally advanced or metastatic colorectal cancer patients | Experimental | ● Samples collection:
Blood samples 2 x 9 ml at day 1 2 x 9ml at day 15
Plasma samples 2 x 9 ml at day 1 4 x 9 ml at day 29 4 x 9 ml at week 8 or 12 and every 8 or 12 weeks thereafter (+/- 7 days) until evidence of progressive disease by RECIST 1.1 (according to local assessment) Receives: Other: Blood Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal timepoint and cut-off value for early on-treatment ctDNA changes
To select the optimal timepoint and cut-off value for early on-treatment ctDNA changes (as assessed by F1Monitor) that predict progressive disease as best radiological response with a high degree of specificity.
Measured: at 2 or 3 weeks
Secondary outcomes (4)
optimal timepoint and cut-off value for on-treatment ctDNA changes at 4 or 6 weeks
To select the optimal timepoint and cut-off value for on-treatment ctDNA changes at 4 or 6 weeks (as assessed by F1Monitor) that predict progressive disease as best radiological response with a high degree of specificity.
Measured: Day 29 or 43
rapid turnaround time of ctDNA testing based on F1LCDx
To demonstrate rapid turnaround time of ctDNA testing based on F1LCDx and identify technical or logistical challenges to the implementation of an on-treatment ctDNA-driven treatment approach in a follow-on study.
Measured: through study completion, an average of 1 year
tumour heterogeneity
To evaluate tumour heterogeneity before treatment start as assessed by F1CDx in the tumour tissue and F1LCDx in the whole blood.
Measured: Day 1
CGP changes during treatment
To track CGP changes during treatment as assessed by F1LCDx.
Measured: Day 1 and 15 or D1 and D22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start12 Oct 2023
- Primary completion24 Aug 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unresectable Locally Advanced Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487248
- Sponsor's protocol ID
- IJB-COPERNIC-ODN-012
- Acronym
- COPERNIC
- Status last verified
- Aug 2026
- First submitted
- 27 May 2022
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Assaf I, Bregni G, Anthoine G, Aparicio T, Artru P, Abdelghani MB, Buyse M, Chibaudel B, Coart E, Diaz M, Evrard C, Geboes K, Ghiringhelli F, Puleo F, Raimbourg J, Vandamme T, Van den Eynde M, Hendlisz A, Sclafani F. Rationale and Design of the COPERNIC Trial: A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients. Clin Colorectal Cancer. 2025 Mar;24(1):101-105. doi: 10.1016/j.clcc.2024.08.004. Epub 2024 Sep 3.
PubMed 39341700
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT05487248
- Acronym / sponsor ID
- COPERNIC / IJB-COPERNIC-ODN-012
- Conditions
- Unresectable Locally Advanced Colorectal Cancer, Metastatic Colorectal Cancer, Candidate for Third-line or Subsequent Lines of Therapy
- Keywords
- colorectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
COPERNIC is an international, multicentre, single-arm study. Chemo-refractory mCRC subjects who meet all eligibility criteria will be treated with standard systemic chemotherapy (the decision about the treatment regimen being made by the treating physician) and undergo tumour assessment by standard imaging (either CT scan or MRI scan) at baseline and every 8 or 12 weeks until evidence of tumour progression. Response to treatment will be assessed by the local investigators according to the RECIST criteria version 1.1. Blinded, independent central review of the imaging scan will be carried out, this having no impact on treatment decisions thatwhich will remain the prerogative of the treating physician.
Serial blood samples from study subjects will be collected at pre-defined time points for ctDNA testing. Also, archived tumour tissue from each subject will be collected. Prospective and retrospective ctDNA analyses on blood samples will be carried out, and dynamics of ctDNA will be correlated with treatment outcomes prognosis.
Detailed description
COPERNIC is an international, multicentre, single-arm study. Chemo-refractory mCRC subjects who meet all eligibility criteria will be treated with standard systemic chemotherapy (the decision about the treatment regimen being made by the treating physician) and undergo tumour assessment by standard imaging (either CT scan or MRI scan) at baseline and every 8 or 12 weeks until evidence of tumour progression. Response to treatment will be assessed by the local investigators according to the RECIST criteria version 1.1. Blinded, independent central review of the imaging scan will be carried out, this having no impact on treatment decisions which will remain the prerogative of the treating physician.
Serial blood samples from study subjects will be collected at pre-defined time points for ctDNA testing. Also, archived tumour tissue from each subject will be collected. Prospective and retrospective ctDNA analyses on blood samples will be carried out, and dynamics of ctDNA will be correlated with prognosis.
Two ctDNA assays will be used in this study:
- FoundationOne Liquid CDx (F1LCDx) for comprehensive genomic profile (CGP) assessment
- F1Monitor for monitoring purpose
For subjects receiving treatments with a 2- or 4-weekly schedule, blood and plasma samples for ctDNA testing will be collected at the following timepoints:
Blood :
- Before treatment start (day 1)
- 2 weeks after treatment start (day 15)
Plasma :
- Before the treatment start (day 1)
- 4 weeks after treatment start (day 29)
- 8 or 12 weeks after treatment start and every 8 or 12 weeks thereafter (i.e. at the same time of each imaging tumour assessment) until evidence of progressive disease by RECIST 1.1
For subjects receiving treatments with a 3-weekly schedule, blood and plasma samples for ctDNA testing will be collected at the following timepoints:
Blood :
- Before treatment start (day 1)
- 3 weeks after treatment start (day 22)
Plasma :
- Before treatment start (day 1)
- 6 weeks after treatment start (day 43)
- 8 or 12 weeks after treatment start and every 8 or 12 weeks thereafter (i.e. at the same time of each imaging tumour assessment) until evidence of progressive disease by RECIST 1.1 ctDNA analyses will be done in a centralised laboratory (Foundation Medicine Inc). Full report of the ctDNA analysis will be provided to the study team to allow correlation with clinical data and exploratory analyses. The results of the ctDNA analysis will not be communicated to the treating physician (with the only exception of the analysis by F1CDx on tumour tissue at screening) and therefore will not have any impact on treatment decision (i.e., all study subjects will be treated according to standard practice).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unresectable locally advanced or metastatic colorectal cancer patients | Experimental | Other: Blood Sample Collection● Samples collection: Blood samples 2 x 9 ml at day 1 2 x 9ml at day 15 Plasma samples 2 x 9 ml at day 1 4 x 9 ml at day 29 4 x 9 ml at week 8 or 12 and every 8 or 12 weeks thereafter (+/- 7 days) until evidence of progressive disease by RECIST 1.1 (according to local assessment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years old
- Male or female
- ECOG performance status ≤2
- Must have histologically or cytologically verified colorectal cancer adenocarcinoma
- Inoperable locally advanced or metastatic disease
Key exclusion criteria (8 listed)
- Tumours other than colorectal cancer
- Histologies other than adenocarcinoma
- Any baseline medical condition that would contraindicate the use of systemic chemotherapy or may preclude the regular administration of the same
- Any psychiatric condition that would prohibit the understanding or rendering of informed consent
- Other invasive malignancy within 3 years except for non-invasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sample CollectionFor subjects receiving treatments with a 2- or 4-weekly schedule, samples for ctDNA testing will be collected at the following timepoints: Blood : * Before treatment start (day 1) * 2 weeks after treatment start (day 15) Plasma : * Before the treatment start (day 1) * 4 weeks after treatment start (day 29) * 8 or 12 weeks after treatment start and every 8 or 12 weeks thereafter (i.e. at the same time of each imaging tumour assessment) until evidence of progressive disease by RECIST 1.1 For subjects receiving treatments with a 3-weekly schedule, samples for ctDNA testing will be collected at the following timepoints: Blood : * Before treatment start (day 1) * 3 weeks after treatment start (day 22) Plasma : * Before treatment start (day 1) * 6 weeks after treatment start (day 43) * 8 or 12 weeks after treatment start and every 8 or 12 weeks thereafter (i.e. at the same time of each imaging tumour assessment) until evidence of progressive disease by RECIST 1.1 | Other | Unresectable locally advanced or metastatic colorectal cancer patients |
Primary outcome
Optimal timepoint and cut-off value for early on-treatment ctDNA changes
Time frame: at 2 or 3 weeks
To select the optimal timepoint and cut-off value for early on-treatment ctDNA changes (as assessed by F1Monitor) that predict progressive disease as best radiological response with a high degree of specificity.
4 secondary outcomes
optimal timepoint and cut-off value for on-treatment ctDNA changes at 4 or 6 weeks
Time frame: Day 29 or 43
rapid turnaround time of ctDNA testing based on F1LCDx
Time frame: through study completion, an average of 1 year
tumour heterogeneity
Time frame: Day 1
CGP changes during treatment
Time frame: Day 1 and 15 or D1 and D22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Derived from this study: PubMed 39341700Assaf I, Bregni G, Anthoine G, Aparicio T, Artru P, Abdelghani MB, Buyse M, Chibaudel B, Coart E, Diaz M, Evrard C, Geboes K, Ghiringhelli F, Puleo F, Raimbourg J, Vandamme T, Van den Eynde M, Hendlisz A, Sclafani F. Rationale and Design of the COPERNIC Trial: A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients. Clin Colorectal Cancer. 2025 Mar;24(1):101-105. doi: 10.1016/j.clcc.2024.08.004. Epub 2024 Sep 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Sample Collection in people with Unresectable Locally Advanced Colorectal Cancer and Metastatic Colorectal Cancer, run by Jules Bordet Institute at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal timepoint and cut-off value for early on-treatment ctDNA changes (time frame: at 2 or 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05487248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.