Colorectal NeoplasmsSMARTNCT06989814
Smart Measurement of Circulating Tumor DNA
A study testing Blood Product in people with Colorectal Neoplasms and Colorectal Neoplasms Malignant, run by Erasmus Medical Center at 2 sites in Netherlands.
Trial summary
The goal of this study is to develop a blood-test which can detect colorectal cancer in early stages. Participants will be asked to take an extra blood test, which will be analyzed further in the lab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Colorectal Neoplasms Malignant, Colorectal Neoplasms, Hereditary Nonpolyposis
- What is being tested?
- Blood Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesNetherlands
- Study dates
- 16 May 2025to 1 Feb 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (suspect) Lynch Syndrome carriers who:
- Have proven Lynch Syndrome (MMR-gene or EPCAM mutation), or have a proven microsatellite instability high (MSI-H)tumor;
- Are at least 18 years old; Have been diagnosed with any form of cancer at the time of inclusion, but have had no treatment yet;
- Have granted informed consent to participate in this study.
Who cannot join
- (suspect) Lynch Syndrome carriers who:
- Are unwilling to undergo extra blood sampling;
- Are under the age of 18;
- Have no newly diagnosed tumors at time of inclusion;
- Have been treated for their tumor at time of inclusion;
- Are not able to read or understand Dutch language or are mentally not capable.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Leiden University Medical Center
Leiden, South Holland, 2333ZG
Maartje Nielsen, Dr., +31624240843, m.nielsen@lumc.nl
Monique van Leerdam, Prof.dr.
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015GD
Lotte van Leeuwen, BSc, 0646245198, l.vanleeuwen@erasmusmc.nl
Anja Wagner, Dr.
About this study
Official title: Smart Measurement of Circulating Tumor DNA: a Tumor-agnostic Computational Tool to Improve Colorectal Cancer Care
The goal of this study is to develop a blood-test which can detect colorectal cancer in early stages.
Participants will be asked to take an extra blood test, which will be analyzed further in the lab.
Read the detailed description
Lynch Syndrome (LS) carriers have a predisposition to develop various types of cancer, especially colorectal cancer (CRC) and endometrial cancer (EC). LS patients are advised to undergo surveillance by colonoscopy every 2 year and gynaecological surveillance. This surveillance is deemed burdensome and fails to detect a small part of the developing CRCs and the majority of extra-colonic cancers. To ensure prevention and early detection of cancer, a reliable and accessible test is needed. Recent studies have shown the potential of the detection of tumor-derived DNA fragments (circulating tumor DNA; ctDNA). Various molecular characteristics can be used to discriminate ctDNA from healthy circulating cell-free DNA. Current ctDNA assays with the highest sensitivity and specificity to detect for example minimal residual disease (MRD) after surgery are mostly tumor-informed, which means prior information is needed from the tumor tissue about the molecular alterations present.
As this information is not available for the detection of newly arising tumors, the aim of this study is to evaluate the use of an optimized combination of tumor agnostic ctDNA characteristics for the detection of newly developing tumors.
- Conditions
- Colorectal Neoplasms, Colorectal Neoplasms Malignant, Colorectal Neoplasms, Hereditary Nonpolyposis, Hereditary Nonpolyposis Colon Cancer
- Being tested
- Blood Product
- Keywords
- Liquid Biopsy, Colorectal cancer, Early detection, Prevention, Surveillance, Screening
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood ProductDiagnostic test
Also called Blood test, Blood draw, Liquid biopsy
An (extra) blood test will be done on participants. This will be analyzed for circulating tumor DNA (ctDNA) via a multi-omics approach.
| Study group | Role | What they receive |
|---|---|---|
| Lynch-carriers with a (colorectal) tumor | Experimental | People with a newly diagnosed Lynch-associated tumor will be asked to undergo an extra blood test. Receives: Diagnostic Test: Blood Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated ctDNA fractions in blood
ctDNA presence will be measured against a (presently not specified) threshold, creating a divide between 'detectable' and 'non-detectable'.
Measured: Measurement at baseline
Tumor pathology
Tumor pathology will be revised to later compare with estimated ctDNA presence.
Measured: Measurement at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start16 May 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case-control study.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society, Leiden University Medical Center
- Responsible party
- Principal investigator, Lotte van Leeuwen, Erasmus Medical Center
- Investigators
- Anja Wagner, Dr., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989814
- Sponsor's protocol ID
- NL87476.078.24
- Other IDs
- 14976
- Acronym
- SMART
- Status last verified
- Aug 2025
- First submitted
- 8 May 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be pseudonymized for privacy purposes. Also, data will be interpreted in group form, individual patients will not receive any results on individual level.
Publications
Mouliere F, Chandrananda D, Piskorz AM, Moore EK, Morris J, Ahlborn LB, Mair R, Goranova T, Marass F, Heider K, Wan JCM, Supernat A, Hudecova I, Gounaris I, Ros S, Jimenez-Linan M, Garcia-Corbacho J, Patel K, Ostrup O, Murphy S, Eldridge MD, Gale D, Stewart GD, Burge J, Cooper WN, van der Heijden MS, Massie CE, Watts C, Corrie P, Pacey S, Brindle KM, Baird RD, Mau-Sorensen M, Parkinson CA, Smith CG, Brenton JD, Rosenfeld N. Enhanced detection of circulating tumor DNA by fragment size analysis. Sci Transl Med. 2018 Nov 7;10(466):eaat4921. doi: 10.1126/scitranslmed.aat4921.
PubMed 30404863Deger T, Boers RG, de Weerd V, Angus L, van der Put MMJ, Boers JB, Azmani Z, van IJcken WFJ, Grunhagen DJ, van Dessel LF, Lolkema MPJK, Verhoef C, Sleijfer S, Martens JWM, Gribnau J, Wilting SM. High-throughput and affordable genome-wide methylation profiling of circulating cell-free DNA by methylated DNA sequencing (MeD-seq) of LpnPI digested fragments. Clin Epigenetics. 2021 Oct 20;13(1):196. doi: 10.1186/s13148-021-01177-4.
PubMed 34670587Schrag D, Beer TM, McDonnell CH 3rd, Nadauld L, Dilaveri CA, Reid R, Marinac CR, Chung KC, Lopatin M, Fung ET, Klein EA. Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023 Oct 7;402(10409):1251-1260. doi: 10.1016/S0140-6736(23)01700-2.
PubMed 37805216Eikenboom EL, Wilting SM, Deger T, Srebniak MI, Van Veghel-Plandsoen M, Boers RG, Boers JB, van IJcken WFJ, Gribnau JH, Atmodimedjo P, Dubbink HJ, Martens JWM, Spaander MCW, Wagner A. Liquid Biopsies for Colorectal Cancer and Advanced Adenoma Screening and Surveillance: What to Measure? Cancers (Basel). 2023 Sep 17;15(18):4607. doi: 10.3390/cancers15184607.
PubMed 37760576
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Measurement of Circulating Tumor DNA: a Tumor-agnostic Computational Tool to Improve Colorectal Cancer Care
- ClinicalTrials.gov ID
- NCT06989814
- Acronym / sponsor ID
- SMART / NL87476.078.24
- Conditions
- Colorectal Neoplasms, Colorectal Neoplasms Malignant, Colorectal Neoplasms, Hereditary Nonpolyposis, Hereditary Nonpolyposis Colon Cancer
- Keywords
- Liquid Biopsy, Colorectal cancer, Early detection, Prevention, Surveillance, Screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society, Leiden University Medical Center
- Study start
- 16 May 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 25 May 2025 (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 goal of this study is to develop a blood-test which can detect colorectal cancer in early stages.
Participants will be asked to take an extra blood test, which will be analyzed further in the lab.
Detailed description
Lynch Syndrome (LS) carriers have a predisposition to develop various types of cancer, especially colorectal cancer (CRC) and endometrial cancer (EC). LS patients are advised to undergo surveillance by colonoscopy every 2 year and gynaecological surveillance. This surveillance is deemed burdensome and fails to detect a small part of the developing CRCs and the majority of extra-colonic cancers. To ensure prevention and early detection of cancer, a reliable and accessible test is needed. Recent studies have shown the potential of the detection of tumor-derived DNA fragments (circulating tumor DNA; ctDNA). Various molecular characteristics can be used to discriminate ctDNA from healthy circulating cell-free DNA. Current ctDNA assays with the highest sensitivity and specificity to detect for example minimal residual disease (MRD) after surgery are mostly tumor-informed, which means prior information is needed from the tumor tissue about the molecular alterations present.
As this information is not available for the detection of newly arising tumors, the aim of this study is to evaluate the use of an optimized combination of tumor agnostic ctDNA characteristics for the detection of newly developing tumors.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case-control study.
| Arm | Type | Receives |
|---|---|---|
| Lynch-carriers with a (colorectal) tumor | Experimental | Diagnostic Test: Blood ProductPeople with a newly diagnosed Lynch-associated tumor will be asked to undergo an extra blood test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have proven Lynch Syndrome (MMR-gene or EPCAM mutation), or have a proven microsatellite instability high (MSI-H)tumor;
- Are at least 18 years old; Have been diagnosed with any form of cancer at the time of inclusion, but have had no treatment yet;
- Have granted informed consent to participate in this study.
Key exclusion criteria (6 listed)
- Are unwilling to undergo extra blood sampling;
- Are under the age of 18;
- Have no newly diagnosed tumors at time of inclusion;
- Have been treated for their tumor at time of inclusion;
- Are not able to read or understand Dutch language or are mentally not capable.
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 |
|---|---|---|
| Blood ProductAlso: Blood test, Blood draw, Liquid biopsyAn (extra) blood test will be done on participants. This will be analyzed for circulating tumor DNA (ctDNA) via a multi-omics approach. | Diagnostic test | Lynch-carriers with a (colorectal) tumor |
Primary outcome
Estimated ctDNA fractions in blood
Time frame: Measurement at baseline
ctDNA presence will be measured against a (presently not specified) threshold, creating a divide between 'detectable' and 'non-detectable'.
Tumor pathology
Time frame: Measurement at baseline
Tumor pathology will be revised to later compare with estimated ctDNA presence.
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 11 Aug 2025.
- Background: PubMed 30404863Mouliere F, Chandrananda D, Piskorz AM, Moore EK, Morris J, Ahlborn LB, Mair R, Goranova T, Marass F, Heider K, Wan JCM, Supernat A, Hudecova I, Gounaris I, Ros S, Jimenez-Linan M, Garcia-Corbacho J, Patel K, Ostrup O, Murphy S, Eldridge MD, Gale D, Stewart GD, Burge J, Cooper WN, van der Heijden MS, Massie CE, Watts C, Corrie P, Pacey S, Brindle KM, Baird RD, Mau-Sorensen M, Parkinson CA, Smith CG, Brenton JD, Rosenfeld N. Enhanced detection of circulating tumor DNA by fragment size analysis. Sci Transl Med. 2018 Nov 7;10(466):eaat4921. doi: 10.1126/scitranslmed.aat4921.
- Background: PubMed 34670587Deger T, Boers RG, de Weerd V, Angus L, van der Put MMJ, Boers JB, Azmani Z, van IJcken WFJ, Grunhagen DJ, van Dessel LF, Lolkema MPJK, Verhoef C, Sleijfer S, Martens JWM, Gribnau J, Wilting SM. High-throughput and affordable genome-wide methylation profiling of circulating cell-free DNA by methylated DNA sequencing (MeD-seq) of LpnPI digested fragments. Clin Epigenetics. 2021 Oct 20;13(1):196. doi: 10.1186/s13148-021-01177-4.
- Background: PubMed 37805216Schrag D, Beer TM, McDonnell CH 3rd, Nadauld L, Dilaveri CA, Reid R, Marinac CR, Chung KC, Lopatin M, Fung ET, Klein EA. Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023 Oct 7;402(10409):1251-1260. doi: 10.1016/S0140-6736(23)01700-2.
- Results publication: PubMed 37760576Eikenboom EL, Wilting SM, Deger T, Srebniak MI, Van Veghel-Plandsoen M, Boers RG, Boers JB, van IJcken WFJ, Gribnau JH, Atmodimedjo P, Dubbink HJ, Martens JWM, Spaander MCW, Wagner A. Liquid Biopsies for Colorectal Cancer and Advanced Adenoma Screening and Surveillance: What to Measure? Cancers (Basel). 2023 Sep 17;15(18):4607. doi: 10.3390/cancers15184607.
- Information (in Dutch) on the Dutch Cancer Society websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Participant data will be pseudonymized for privacy purposes. Also, data will be interpreted in group form, individual patients will not receive any results on individual level.
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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.
Anja Wagner, Dr. principal investigator
Erasmus Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Product in people with Colorectal Neoplasms and Colorectal Neoplasms Malignant, run by Erasmus Medical Center at 2 sites 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 4 inclusion and 6 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 11 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 2 sites 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 Lotte van Leeuwen, BSc (+31646245198, l.vanleeuwen@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated ctDNA fractions in blood (time frame: Measurement at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06989814, which also lists 4 linked publications.
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 11 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.