Metastatic Colorectal CancerOn-CALLNCT05755672
On-treatment Biomarkers in Metastatic Colorectal Cancer for Life
An observational study of Metastatic Colorectal Cancer and Chemotherapy Effect, run by Region Skane at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Metastatic Colorectal Cancer, Chemotherapy Effect, Peritoneal Metastases
- What is being tested?
- Chemotherapy, Resection of the primary tumor and Resection of tumour metastases
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Mar 2023to Mar 2033
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who are treated at the Skåne University Hospital
Who may be able to join
- Clinical diagnosis of synchronous metastatic colorectal cancer, planned cancer treatment with curative intent at the Skåne University Hospital
Who cannot join
- Not accepting the study inclusion terms (informed consent not obtained)
- Age below or above the age limit
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Department of Oncology, Hematology and Radiophysics, Skane University Hospital
Lund, Skåne County, 22241
Jakob Eberhard, M.D. PhD., +4646177520, jakob.eberhard@med.lu.se
- Recruiting
Department of Oncology, Hematology and Radiophysics, Skane University Hospital
Malmö, Skåne County, 21428
Christina Siesing, M.D. PhD., +4646177841, christina.siesing@skane.se
About this study
Official title: On-treatment Biomarkers in Metastatic Colorectal Cancer for Life: The On-CALL Study
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.
Read the detailed description
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
- Conditions
- Metastatic Colorectal Cancer, Chemotherapy Effect, Peritoneal Metastases, Liver Metastasis Colon Cancer, Lung Metastases
- Being tested
- Chemotherapy, Resection of the primary tumor, Resection of tumour metastases, Blood sampling during chemotherapy
- Keywords
- Metastatic colorectal cancer, Chemotherapy, Targeted therapy, Tumor heterogeneity, Tumor evolution
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Neo-adjuvant and adjuvant chemotherapy with curative intent, according to the current clinical practice guidelines
Resection of the primary tumorProcedure or surgery
Also called Surgical resection of the primary tumour
Surgical resection of the primary tumour, according to the current clinical practice guidelines
Resection of tumour metastasesProcedure or surgery
Also called Surgical resection of tumour metastases
Surgical resection of tumour metastases, according to the current clinical practice guidelines
Blood sampling during chemotherapyProcedure or surgery
Also called Drawing of blood samples during chemotherapy
Drawing of blood samples several times during patient visits for chemotherapy regimen
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Chemotherapy; Procedure: Resection of the primary tumor; Procedure: Resection of tumour metastases; Procedure: Blood sampling during chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 years
Secondary outcomes (1)
Quality of life changes
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Mar 2023
- Primary completionDec 2026 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karin Jirström, M.D. PhD., Study director, Region SkaneJakob Eberhard, M.D. PhD., Study chair, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755672
- Sponsor's protocol ID
- 2022-01242-01
- Acronym
- On-CALL
- Status last verified
- Jul 2025
- First submitted
- 17 Feb 2023
- Last updated
- 17 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-treatment Biomarkers in Metastatic Colorectal Cancer for Life: The On-CALL Study
- ClinicalTrials.gov ID
- NCT05755672
- Acronym / sponsor ID
- On-CALL / 2022-01242-01
- Conditions
- Metastatic Colorectal Cancer, Chemotherapy Effect, Peritoneal Metastases, Liver Metastasis Colon Cancer, Lung Metastases
- Keywords
- Metastatic colorectal cancer, Chemotherapy, Targeted therapy, Tumor heterogeneity, Tumor evolution
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2033 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Synchronous mCRC patients | – | Drug: Chemotherapy, Procedure: Resection of the primary tumor, Procedure: Resection of tumour metastases, Procedure: Blood sampling during chemotherapyPatients 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) |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who are treated at the Skåne University Hospital
Key inclusion criteria (1 listed)
- Clinical diagnosis of synchronous metastatic colorectal cancer, planned cancer treatment with curative intent at the Skåne University Hospital
Key exclusion criteria (2 listed)
- Not accepting the study inclusion terms (informed consent not obtained)
- Age below or above the age limit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyNeo-adjuvant and adjuvant chemotherapy with curative intent, according to the current clinical practice guidelines | Drug | Synchronous mCRC patients |
| Resection of the primary tumorAlso: Surgical resection of the primary tumourSurgical resection of the primary tumour, according to the current clinical practice guidelines | Procedure or surgery | Synchronous mCRC patients |
| Resection of tumour metastasesAlso: Surgical resection of tumour metastasesSurgical resection of tumour metastases, according to the current clinical practice guidelines | Procedure or surgery | Synchronous mCRC patients |
| Blood sampling during chemotherapyAlso: Drawing of blood samples during chemotherapyDrawing of blood samples several times during patient visits for chemotherapy regimen | Procedure or surgery | Synchronous mCRC patients |
Primary outcome
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).
1 secondary outcome
Quality of life changes
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: Undecided
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karin Jirström, M.D. PhD. study director
Region Skane
Jakob Eberhard, M.D. PhD. study chair
Region Skane
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer and Chemotherapy Effect, run by Region Skane at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danyil Kuznyecov, M.D. (+46 725972072, danyil_szergejevics.kuznyecov@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow-up examination of tumour remission, progression or recurrence (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.