Actively Recruiting
On-treatment Biomarkers in Metastatic Colorectal Cancer for Life: The On-CALL Study
Led by Region Skane · Updated on 2025-07-17
100
Participants Needed
2
Research Sites
326 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating metastatic colorectal cancer (mCRC), focusing on how the cancer evolves during treatment and the reasons why treatment sometimes fails. The study aims to understand the genetic changes of mCRC over time and how these changes relate to treatment response and patient survival. This observational study is called On-treatment Biomarkers in Metastatic ColorectAL cancer for Life (On-CALL) and is sponsored by Region Skane. The study involves patients diagnosed with synchronous mCRC who are receiving treatment with curative intent at Skåne University Hospital. Participants will undergo chemotherapy and surgical removal of the primary tumor and any metastases, following current clinical guidelines. Blood samples will be taken multiple times during chemotherapy to analyze biomarkers. Tissue samples from tumors and metastases will be collected to study genetic diversity and tumor evolution. Participants will provide clinical and histopathological data at the start of the study. Researchers will monitor tumor remission, progression, or recurrence over a period of 10 years, alongside quality of life changes. DNA sequencing of tumor tissues and circulating tumor DNA will be performed to assess genetic heterogeneity. Blood tests will evaluate immune cells and inflammatory markers. This long-term follow-up helps reveal how tumors change and respond to treatment over time.
CONDITIONS
Brief Title
On-treatment Biomarkers in Metastatic Colorectal Cancer for Life
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of synchronous metastatic colorectal cancer
- Planned cancer treatment with curative intent at Skåne University Hospital
- Age between 18 and 110 years
- Acceptance of study inclusion terms with informed consent
You will not qualify if you...
- Not accepting the study inclusion terms (informed consent not obtained)
- Age below 18 or above 110 years
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Varies according to clinical treatment course
Participants receive chemotherapy and undergo surgical resection of the primary tumor and tumour metastases according to current clinical practice guidelines.
Several visits during chemotherapy for blood sampling and treatment according to clinical guidelines
Duration - Up to 10 years
Participants are followed up to examine tumour remission, progression, recurrence, and quality of life changes over time.
Follow-up visits over 10 years
Trial Site Locations
Total: 2 locations
1
Department of Oncology, Hematology and Radiophysics, Skane University Hospital
Lund, Skåne County, Sweden, 22241
Actively Recruiting
2
Department of Oncology, Hematology and Radiophysics, Skane University Hospital
Malmö, Skåne County, Sweden, 21428
Actively Recruiting
Research Team
D
Danyil Kuznyecov, M.D.
C
Christina Siesing, M.D. PhD.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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