A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients

NCT05487248 | Active Not Recruiting

• 1 other identifier: IJB-COPERNIC-ODN-012
• Study Type: interventional
• Target: 103
• Locations: 2 countries
• Sites: 12

Brief 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 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.

Conditions

Metastatic Colorectal Cancer; Unresectable Locally Advanced Colorectal Cancer; Candidate for Third-line or Subsequent Lines of Therapy

Keywords

colorectal cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  at 2 or 3 weeks

Secondary Outcomes (4)

• optimal timepoint and cut-off value for on-treatment ctDNA changes at 4 or 6 weeks

  Day 29 or 43

• rapid turnaround time of ctDNA testing based on F1LCDx

  through study completion, an average of 1 year

• tumour heterogeneity

  Day 1

• CGP changes during treatment

  Day 1 and 15 or D1 and D22

Other Outcomes (2)

• exploratory genomics and radiomics profiles associated with progresdsive disease as best radiological response

  through study completion, an average of 1 year

• prognostic value of ctDNA.

  through study completion, an average of 1 year

Study Arms (1)

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)

Other: Blood Sample Collection

Interventions

Blood Sample Collection OTHER

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

Unresectable locally advanced or metastatic colorectal cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jules Bordet Institute: lead
• Hoffmann-La Roche: collaborator

Study Sites (12)

Institut Jules Bordet

Anderlecht, 1070, Belgium

Location

UZ Antwerpen

Antwerp, Belgium

Location

CHIREC Delta

Brussels, Belgium

Location

CHU Ambroise Pare

Mons, 7000, Belgium

Location

Cliniques Universitaires Saint Luc

Woluwe-Saint-Lambert, 1200, Belgium

Location

Centre Georges François Leclerc

Dijon, France

Location

Hopital Franco-Britannique - Fondation Cognacq-Jay

Levallois-Perret, 92300, France

Location

Hopital privé Jean Mermoz

Lyon, France

Location

Hopital St-Louis

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

ICO Saint-Herblain

Saint-Herblain, France

Location

ICANS Strasbourg

Strasbourg, France

Location

Related Publications (1)

• 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.

  PMID: 39341700 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

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: May 27, 2022
• First Posted: August 4, 2022
• Study Start: October 12, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 12, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-01

Locations

BE (5); FR (7)