Early-onset Colorectal CancerBIO-EOCRCNCT06568679
Earlier Detection and Optimization of Treatment and Prognosis for Patients With Early-onset Colorectal Cancer
An observational study of Early-onset Colorectal Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
The study aims to collect high quality clinical data on lifestyle and patient biomaterials prior to start or during / after treatment of early-onset colorectal cancer (EOCRC) and to inform on treatment and survival outcomes of EOCRC patients. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Early-onset Colorectal Cancer
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Jan 2025to 1 Dec 2038
- 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 49 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with histologically proven CRC aged 18-49 years (EOCRC) are eligible for participation in this study regardless of stage and treatment of the disease.
Who may be able to join
- Patients with locoregional or metastatic colorectal cancer (CRC)
- Histologically proven CRC
- Age 18 - 49 years at time of first CRC diagnosis
- Able to understand the informed consent form
- Provide written informed consent.
Who cannot join
- Mentally incompetent patients based on the opinion of treating physician
- Inability to understand the Dutch language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Netherlands Cancer Institute
Amsterdam, North Holland, 1066CX
Karen Bolhuis, +31205129111, k.bolhuis@nki.nl
About this study
Official title: Striving for Earlier Detection and Optimization of Treatment and Prognosis for Patients With Early-onset Colorectal Cancer (EOCRC); BIO-EOCRC Study
The study aims to collect high quality clinical data on lifestyle and patient biomaterials prior to start or during / after treatment of early-onset colorectal cancer (EOCRC) and to inform on treatment and survival outcomes of EOCRC patients.
Read the detailed description
The current study will be complementary to COMPRAYA, a prospective cohort study focused on risk factors of impaired medical and psychosocial outcomes of adolescents and young adults with cancer (AYA) and to GENAYA, focused on genetic testing of AYA. The collected data and materials will be essential for an in-depth analysis of the epidemiology, exposomes and pathophysiology of EOCRC and compare this with average-onset CRC (AOCRC) and healthy controls. These data will facilitate multiomics studies and the identification of high-risk profiles and blood- and/or stool-based biomarkers, which in turn will enable the development of prevention and early detection strategies to ultimately improve prognosis and the prevalence, risk factors and mechanisms of impaired health outcomes (short- and long-term medical and psychosocial effects and late effects) over time among EOCRC patients wil be examined.
- Conditions
- Early-onset Colorectal Cancer
- Being tested
- No intervention; observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention; observationalOther
No intervention; observational
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploratory data analysis through a multiomics approach describing tumor biology and pathogenesis of patients with EOCRC
Associations between exposome (lifestyle factors and microbiome composition), genomics and transcriptomics and EOCRC will be determined by multivariate analysis. Multivariate tests will be applied to account for the complexity of the data and the multitude of variables involved, this will include multiple regression analysis, logistic regression analysis, and analysis of variance (ANOVA). These tests will allow us to identify and quantify the correlation between the factors and better understand the underlying mechanisms of EOCRC.
Measured: Change from baseline throughout follow-up of 10 years
Secondary outcomes (7)
Second tumor
Linkage to the Netherlands Cancer Registry (NCR) and nationwide National Pathology Database (PALGA) to asses second malignancies.
Measured: Change from baseline throughout follow-up of 10 years
Psychological distress
Psychological distress will be assessed at each time point with the Hospital Anxiety and Depression Scale (HADS), with seven items each for assessing symptoms of anxiety and depression
Measured: Change from baseline throughout follow-up of 10 years
Survival
Linkage will done with the Personal Records Database (BRP) to have information on survival status
Measured: Change from baseline throughout follow-up of 10 years
Germline variants will be analysed in the carcinogenesis of EOCRC
The frequencies of germline variants that are known risk factors to cancer development will be determined. Generally, hereditary colorectal cancers will be analyzed both together with and separately from sporadic colorectal cancers. The contribution of germline variants to carcinogenesis via mutational signatures will be determined, where possible, using linear mixed models.
Measured: Change from baseline throughout follow-up of 10 years
To compare stage-specific treatment and survival outcomes of patients with EOCRC with those of AOCRC (≥ 50 years)
Treatment and survival outcomes (progression free survival and/or recurrence free survival and overall survival) will be estimated with Kaplan-Meier curves and medians with 95% confidence intervals (CIs) will be presented and will be compared to survival outcomes of AOCRC (≥ 50 years) of a matched control group from the NCR.
Measured: Change from baseline throughout follow-up of 10 years
High risk profiles
By a multiomics approach associations between exposomes (lifestyle, microbiome), (epi-)genomics and transcriptomics in EOCRC development and tumor phenotype will be analysed to assign high risk profiles to provide rationale for the selection of target populations that should be offered CRC screening at an earlier age.
Measured: Change from baseline throughout follow-up of 10 years
Geno-phenotype associations
Geno-phenotype associations of patients will be analysed in-depth based on whole genome sequencing (WGS), histopathological features and survival outcomes.
Measured: Change from baseline throughout follow-up of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start27 Jan 2025
- Primary completion1 Dec 2037 (estimated)
- Study completion1 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-onset Colorectal CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Bolhuis, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568679
- Sponsor's protocol ID
- N24ECR
- Acronym
- BIO-EOCRC
- Status last verified
- Jul 2025
- First submitted
- 16 Aug 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Striving for Earlier Detection and Optimization of Treatment and Prognosis for Patients With Early-onset Colorectal Cancer (EOCRC); BIO-EOCRC Study
- ClinicalTrials.gov ID
- NCT06568679
- Acronym / sponsor ID
- BIO-EOCRC / N24ECR
- Conditions
- Early-onset Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 1 Dec 2037 (estimated)
- Study completion
- 1 Dec 2038 (estimated)
- First posted
- 23 Aug 2024 (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.
The study aims to collect high quality clinical data on lifestyle and patient biomaterials prior to start or during / after treatment of early-onset colorectal cancer (EOCRC) and to inform on treatment and survival outcomes of EOCRC patients.
Detailed description
The current study will be complementary to COMPRAYA, a prospective cohort study focused on risk factors of impaired medical and psychosocial outcomes of adolescents and young adults with cancer (AYA) and to GENAYA, focused on genetic testing of AYA. The collected data and materials will be essential for an in-depth analysis of the epidemiology, exposomes and pathophysiology of EOCRC and compare this with average-onset CRC (AOCRC) and healthy controls. These data will facilitate multiomics studies and the identification of high-risk profiles and blood- and/or stool-based biomarkers, which in turn will enable the development of prevention and early detection strategies to ultimately improve prognosis and the prevalence, risk factors and mechanisms of impaired health outcomes (short- and long-term medical and psychosocial effects and late effects) over time among EOCRC patients wil be examined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with histologically proven CRC aged 18-49 years (EOCRC) are eligible for participation in this study regardless of stage and treatment of the disease.
Key inclusion criteria (5 listed)
- Patients with locoregional or metastatic colorectal cancer (CRC)
- Histologically proven CRC
- Age 18 - 49 years at time of first CRC diagnosis
- Able to understand the informed consent form
- Provide written informed consent.
Key exclusion criteria (2 listed)
- Mentally incompetent patients based on the opinion of treating physician
- Inability to understand the Dutch language
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 |
|---|---|---|
| No intervention; observationalNo intervention; observational | Other | – |
Primary outcome
Exploratory data analysis through a multiomics approach describing tumor biology and pathogenesis of patients with EOCRC
Time frame: Change from baseline throughout follow-up of 10 years
Associations between exposome (lifestyle factors and microbiome composition), genomics and transcriptomics and EOCRC will be determined by multivariate analysis. Multivariate tests will be applied to account for the complexity of the data and the multitude of variables involved, this will include multiple regression analysis, logistic regression analysis, and analysis of variance (ANOVA). These tests will allow us to identify and quantify the correlation between the factors and better understand the underlying mechanisms of EOCRC.
7 secondary outcomes
Second tumor
Time frame: Change from baseline throughout follow-up of 10 years
Psychological distress
Time frame: Change from baseline throughout follow-up of 10 years
Survival
Time frame: Change from baseline throughout follow-up of 10 years
Germline variants will be analysed in the carcinogenesis of EOCRC
Time frame: Change from baseline throughout follow-up of 10 years
To compare stage-specific treatment and survival outcomes of patients with EOCRC with those of AOCRC (≥ 50 years)
Time frame: Change from baseline throughout follow-up of 10 years
High risk profiles
Time frame: Change from baseline throughout follow-up of 10 years
Geno-phenotype associations
Time frame: Change from baseline throughout follow-up of 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 5 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Early-onset Colorectal Cancer
Not yet recruiting
Preventing Early-Onset Colorectal Cancer in the VA
Colorectal Neoplasms, Mass Screening
Recruiting
Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial
Colorectal Cancer, Metastatic Colon Cancer
Not yet recruiting
Study Aiming to Test Whether Non-invasive Liquid Biopsies Can Safely Reduce Invasive Surveillance Methods in Lynch Syndrome
Lynch Syndrome
RecruitingObservational study
Early Onset Colorectal Cancer Detection
Colorectal Cancer, Colorectal Neoplasms
RecruitingObservational study
CARE-CRC: Microbiome Insights and Correlations for Risk and Outcomes in Colorectal Cancer
Colorectal Cancer (CRC), Microbiome
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.
Karen Bolhuis, MD, PhD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early-onset Colorectal Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 5 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 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 Ruud Weijer, PhD (+31205129111, r.weijer@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploratory data analysis through a multiomics approach describing tumor biology and pathogenesis of patients with EOCRC (time frame: Change from baseline throughout follow-up of 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 5 Aug 2025.