Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT05487248

Reclutamiento

COPERNIC: A Study of On-treatment CtDNA Changes in Chemo-refractory Colorectal Cancer Patients

Intervencionista

Fase no especificada

Centre Georges François Leclerc

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.

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Categoría de tratamiento

Otros

Erforderliche Mutationen

Ninguna

Ensayo iniciado

2023-10-12

Última actualización por el patrocinador

2025-03-25

Finalización estimada

2026-04-12

Elegibilidad

Criterios de inclusión

1. Age ≥ 18 years old

2. Male or female

3. ECOG performance status ≤2

4. Must have histologically or cytologically verified colorectal cancer adenocarcinoma

5. Inoperable locally advanced or metastatic disease

6. 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

7. 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)

8. Candidate for standard third-line or subsequent lines of therapy as per decision of the treating physician

9. Life expectancy of at least 3 months

10. Women of childbearing potential must have a negative serum pregnancy test done within 28 days prior to enrolment.

11. Effective contraception is in place for women of childbearing potential.

12. Completion of all necessary screening procedures within 28 days prior to enrolment.

13. Availability of archived tumour tissue

14. Signed Informed Consent form (ICF) obtained prior to any study related procedure.

15. Affiliated to the French Social Security System

Criterios de exclusión

1. Tumours other than colorectal cancer

2. Histologies other than adenocarcinoma

3. Any baseline medical condition that would contraindicate the use of systemic chemotherapy or may preclude the regular administration of the same

4. Any psychiatric condition that would prohibit the understanding or rendering of informed consent

5. 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

6. 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.

7. Pregnant and/ or lactating women

8. 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.

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Detalles del diseño

AsignaciónN/A

Modelo de intervenciónSingle Group Assignment

EnmascaramientoNone (Open Label)

Número a inscribir103

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: Experimental

Descripción: ● 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)

Intervenciones:

Blood Sample Collection

Medidas de resultado

Medidas de resultado primarias

Optimal timepoint and cut-off value for early on-treatment ctDNA changesat 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.

Medidas de resultado secundarias

rapid turnaround time of ctDNA testing based on F1LCDxthrough study completion, an average of 1 year

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.

tumour heterogeneityDay 1

To evaluate tumour heterogeneity before treatment start as assessed by F1CDx in the tumour tissue and F1LCDx in the whole blood.

CGP changes during treatmentDay 1 and 15 or D1 and D22

To track CGP changes during treatment as assessed by F1LCDx.

exploratory genomics and radiomics profiles associated with progresdsive disease as best radiological responsethrough study completion, an average of 1 year

To characterize the positive predictive value of baseline genomic and radiomic profiles for tumour progression at the first radiological assessment

prognostic value of ctDNA.through study completion, an average of 1 year

To confirm the prognostic value of ctDNA.

optimal timepoint and cut-off value for on-treatment ctDNA changes at 4 or 6 weeksDay 29 or 43

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.

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Sitios del ensayo

Este estudio tiene 5 sitios de ensayo

Centre Georges François Leclerc
Dijon, FR

Reclutando

Antwerpen, BE

UZ Antwerpen

Reclutando

Mons, 7000 BE

CHU Ambroise Pare

Reclutando

Anderlecht, 1070 BE

Institut Jules Bordet

Reclutando

Brussels, BE

CHIREC Delta

Reclutando

Woluwe-Saint-Lambert, 1200 BE

Cliniques Universitaires Saint Luc

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