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NCT Number: NCT05755672

On-treatment Biomarkers in Metastatic Colorectal Cancer for Life

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.

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Key information

Conditions

Metastatic Colorectal Cancer Chemotherapy Effect Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Metastasis Colon Cancer Lung Metastases Neoplasms Neoplasms by Site Peritoneal Metastases Rectal Diseases

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Oncology, Hematology and Radiophysics, Skane University Hospital, Lund, Skåne County, Sweden

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About this study

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 with curative intent, and to elucidate the mechanisms underlying the therapeutic failure still seen in a substantial number of patients.

The specific objectives are:

  • To comprehensively characterise the spatial intertumoural, intermetastatic and intrametastatic genetic heterogeneity
  • To delineate differences in the prevalence and type of genetic heterogeneity, as well as tumour evolvability, according to metastatic site
  • To examine the associations between spatial and temporal heterogeneity
  • To examine ctDNA quantity and quality as an early biomarker for response to neoadjuvant treatment
  • To examine ctDNA quantity and quality as an early biomarker for response to adjuvant treatment
  • To evaluate the relationship between phylogenetic patterns, i.e. the tumour evolvability, and survival in relation to different treatment modalities
  • To examine the heterogeneity of the tumour microenvironment in relation to the genetic heterogeneity and evolvability of the tumours
  • To examine circulating immune cells and inflammatory biomarkers, and their relationship with the genetic and microenvironmental heterogeneity of the tumours
  • To delineate parallel events at the transcriptomic and proteomic levels, with particular reference to their potential utility as clinically relevant surrogate biomarkers of genetic alterations underlying the evolvability of the tumours

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of synchronous metastatic colorectal cancer, planned cancer treatment with curative intent at the Skåne University Hospital

Exclusion criteria

  • Not accepting the study inclusion terms (informed consent not obtained)
  • Age below or above the age limit

Treatment and study plan

Chemotherapy

Drug

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

Resection of the primary tumor

Procedure

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

Other names: Surgical resection of the primary tumour

Resection of tumour metastases

Procedure

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

Other names: Surgical resection of tumour metastases

Blood sampling during chemotherapy

Procedure

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

Other names: Drawing of blood samples during chemotherapy

Primary outcomes

  1. Follow-up examination of tumour remission, progression or recurrence

    Time frame: 10 years

    Radiological/clinical examination of tumour remission, progression or recurrence, and correlation of this clinical information with the available oncogenetic data from histological samples from the primary tumour and metastases, and from data from blood samples (ctDNA analysis)

    • Oncogenetic data will come from genomic profiling of tissue samples. This will be carried out by targeted deep sequencing (TDS), using a comprehensive panel covering cancer-related genes, in combination with genome wide SNP array for detection of copy number aberrations.
    • Data from blood samples will be extracted through quantification of ctDNA and monitoring of the temporal clonal dynamics (circulating cell free DNA will be extracted from plasma samples from all time points).

Secondary outcomes

  1. Quality of life changes

    Time frame: 10 years

    Patients will take quality-of-life surveys (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - version EORTC-QLQ-C30 and EORTC-QLQ-CR29) will assistance of medical professionals prior to and after neoadjuvant and/or adjuvant treatment.

    • These surveys are cancer-specific core questionnaires for use in relation to various cancers.
    • The questionnaire scales the items on a score of 1 (Not at all) to 4 (Very much), and 1 (Very poor) to 7 (Excellent).
    • Scoring result is 0 to 100; for functional and global quality of life scales, higher scores mean a better level of functioning, and for symptom-oriented scales, a higher score means worse/more severe symptoms.
    • Statistical analysis will be performed with the data from the questionnaires, and the evolution/changes of symptoms and subjective experiences of the patients will be quantified and correlated with the clinical findings.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Siesing, M.D. PhD.

CONTACT

[email protected]

+4646177841

Danyil Kuznyecov, M.D.

CONTACT

[email protected]

+46 725972072

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

On-treatment Biomarkers in Metastatic Colorectal Cancer for Life: The On-CALL Study

Acronym: On-CALL

Important dates

Study start
2023
Primary completion
2026
Study completion
2033
First posted
Mar 6, 2023
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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