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On-treatment Biomarkers in Metastatic Colorectal Cancer for Life

NCT05755672 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-07-17

No results posted yet for this study

Summary

By virtue of an increased strategic use of cytotoxic and biological agents, and more options for locoregional treatment, the survival of patients with metastatic colorectal cancer (mCRC) has improved considerably in the past decades. The personalized approach to systemic treatment is further aided by the use of complementary molecular biomarkers. However, the evolutionary dynamics of mCRC, a disease harnessed by multiple adaptive genetic alterations towards its final stages, poses a particular challenge to single-sample biomarker analyses and standardized linear treatment protocols. The aim of the On-treatment biomarkers in metastatic ColorectAL cancer for Life (On-CALL) study is to generate further knowledge on the evolutionary progression of mCRC during treatment, and to elucidate the mechanisms underlying the therapeutic failure still seen in a substantial number of patients.

The On-CALL study is a prospective, single-arm observational study. All patients diagnosed with synchronous mCRC treated with curative intent at Skåne University Hospital will be invited to participate. Clinical and histopathological data will be compiled at study entry. An individual tissue microarray block with samples from resected primary tumours and metastases representing the full extent of the tumour spread will be constructed for each patient. Blood samples will be drawn for biomarker analyses at multiple time points prior to, during and after systemic treatment. DNA sequencing of tumour tissue and circulating tumour DNA (ctDNA) will be performed to define the spatial clonal landscape in primary tumours and metastases, as well as over time.

Conditions

Interventions

DRUG

Chemotherapy

Neo-adjuvant and adjuvant chemotherapy with curative intent, according to the current clinical practice guidelines

PROCEDURE

Resection of the primary tumor

Surgical resection of the primary tumour, according to the current clinical practice guidelines

PROCEDURE

Resection of tumour metastases

Surgical resection of tumour metastases, according to the current clinical practice guidelines

PROCEDURE

Blood sampling during chemotherapy

Drawing of blood samples several times during patient visits for chemotherapy regimen

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Karin Jirström, M.D. PhD. · Region Skåne

  • Jakob Eberhard, M.D. PhD. · Region Skåne

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2026-12-31
Completion
2033-03-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05755672 on ClinicalTrials.gov