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Trial Title:
On-treatment Biomarkers in Metastatic Colorectal Cancer for Life
NCT ID:
NCT05755672
Condition:
Metastatic Colorectal Cancer
Chemotherapy Effect
Peritoneal Metastases
Liver Metastasis Colon Cancer
Lung Metastases
Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Conditions: Keywords:
Metastatic colorectal cancer
Chemotherapy
Targeted therapy
Tumor heterogeneity
Tumor evolution
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Neo-adjuvant and adjuvant chemotherapy with curative intent, according to the current
clinical practice guidelines
Arm group label:
Synchronous mCRC patients
Intervention type:
Procedure
Intervention name:
Resection of the primary tumor
Description:
Surgical resection of the primary tumour, according to the current clinical practice
guidelines
Arm group label:
Synchronous mCRC patients
Other name:
Surgical resection of the primary tumour
Intervention type:
Procedure
Intervention name:
Resection of tumour metastases
Description:
Surgical resection of tumour metastases, according to the current clinical practice
guidelines
Arm group label:
Synchronous mCRC patients
Other name:
Surgical resection of tumour metastases
Intervention type:
Procedure
Intervention name:
Blood sampling during chemotherapy
Description:
Drawing of blood samples several times during patient visits for chemotherapy regimen
Arm group label:
Synchronous mCRC patients
Other name:
Drawing of blood samples during chemotherapy
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.
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
Criteria for eligibility:
Study pop:
All patients who are treated at the Skåne University Hospital
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
110 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Oncology, Hematology and Radiophysics, Skane University Hospital
Address:
City:
Lund
Zip:
22241
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Jakob Eberhard, M.D. PhD.
Phone:
+4646177520
Email:
jakob.eberhard@med.lu.se
Facility:
Name:
Department of Oncology, Hematology and Radiophysics, Skane University Hospital
Address:
City:
Malmö
Zip:
21428
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Christina Siesing, M.D. PhD.
Phone:
+4646177841
Email:
christina.siesing@skane.se
Start date:
March 1, 2023
Completion date:
March 2033
Lead sponsor:
Agency:
Region Skane
Agency class:
Other
Source:
Region Skane
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05755672
