On-treatment Biomarkers in Metastatic Colorectal Cancer for Life
On-CALL
1 other identifier
observational
100
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2023
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2023
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2033
July 17, 2025
July 1, 2025
3.8 years
February 17, 2023
July 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Follow-up examination of tumour remission, progression or recurrence
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).
10 years
Secondary Outcomes (1)
Quality of life changes
10 years
Study Arms (1)
Synchronous mCRC patients
Patients diagnosed with synchronous metastatic colorectal cancer with planned treatment with curative intent at Skåne University Hospital (Malmö and Lund), who have accepted the study invitation (agreeing to participation - informed consent)
Interventions
Neo-adjuvant and adjuvant chemotherapy with curative intent, according to the current clinical practice guidelines
Surgical resection of the primary tumour, according to the current clinical practice guidelines
Surgical resection of tumour metastases, according to the current clinical practice guidelines
Drawing of blood samples several times during patient visits for chemotherapy regimen
Eligibility Criteria
All patients who are treated at the Skåne University Hospital
You may qualify if:
- Clinical diagnosis of synchronous metastatic colorectal cancer, planned cancer treatment with curative intent at the Skåne University Hospital
You may not qualify if:
- Age below or above the age limit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
Study Sites (2)
Department of Oncology, Hematology and Radiophysics, Skane University Hospital
Lund, Skåne County, 22241, Sweden
Department of Oncology, Hematology and Radiophysics, Skane University Hospital
Malmo, Skåne County, 21428, Sweden
Biospecimen
* Tissue from the first histological specimen for diagnosis (usually a biopsy) * Blood sample during ongoing neoadjuvant and/or adjuvant chemotherapy * Tissue from the surgical resection specimen (primary tumour and resected metastases)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Karin Jirström, M.D. PhD.
Region Skåne
- STUDY CHAIR
Jakob Eberhard, M.D. PhD.
Region Skåne
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2023
First Posted
March 6, 2023
Study Start
March 1, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
March 1, 2033
Last Updated
July 17, 2025
Record last verified: 2025-07