Circulating Tumor DNACrEATENCT06434896
Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
A study testing ctDNA analysis after surgery in people with Circulating Tumor DNA and Recurrence, run by UMC Utrecht at 29 sites in Netherlands.
Trial summary
Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circulating Tumor DNA, Recurrence, Colon Cancer Stage II
- What is being tested?
- ctDNA analysis after surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,320 participants
- Where
- 29 sitesNetherlands
- Study dates
- 5 Mar 2020to Dec 2026
- 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
- Age ≥ 18 years
- Informed consent for PLCRC with specific consent for:
- additional blood withdrawals
- collection and use of tissue for scientific research
- invitation for future (experimental) research within the cohort, including TwiCs studies
- Histological confirmed stage II colon cancer
- Fit enough to receive treatment with combination chemotherapy (fluoropyrimidine and oxaliplatin) according to the treating physician
Who cannot join
- Indication for adjuvant chemotherapy according to treating physician
- Another malignancy in previous 5 years, with the exception of treated carcinoma in situ or skin cancer other than melanoma
- Incomplete primary tumor resection (R1 or R2 resection)
- Contra-indication for fluoropyrimidines or oxaliplatin
- Pregnancy
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
Netherlands29 sites, 29 recruiting
- Recruiting
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
M.L. Wumkes
- Recruiting
Noordwest Ziekenhuisgroep
Alkmaar
M.P. Hendriks
- Recruiting
Ziekenhuisgroep Twente
Almelo
R. Hoekstra
- Recruiting
Flevoziekenhuis
Almere Stad
J.D.W. van der Bilt
- Recruiting
Meander Medisch Centrum
Amersfoort
J.M. van Dodewaard
- Recruiting
NKI-AVL
Amsterdam
K. Bolhuis
- Recruiting
Rijnstate
Arnhem
I. Werter
- Recruiting
Amphia Ziekenhuis
Breda
M. Streppel
- Recruiting
Reinier de Graaf Gasthuis
Delft
A.J. Verschoor
- Recruiting
Deventer Ziekenhuis
Deventer
L.W. Kessels
- Recruiting
Albert Schweizer Ziekenhuis
Dordrecht
M. Vidakovic
- Recruiting
Ziekenhuis Gelderse Vallei
Ede
M. Verstappen
- Recruiting
Admiraal de Ruyter Ziekenhuis
Goes
H.K. van Halteren
- Recruiting
Rivas
Gorinchem
M.A. Davidis
- Recruiting
Spaarne Gasthuis
Haarlem
H.B.A.C. Stockmann
- Recruiting
Ziekenhuis St. Jansdal
Harderwijk
A.P. Schouten van der Velden
- Recruiting
Maastricht UMC
Maastricht
L.B.J. Valkenburg
- Recruiting
Van Weel-Bethesda Ziekenhuis
Middelharnis
A. Dietvorst
- Recruiting
St. Antonius Ziekenhuis
Nieuwegein
M. Los
- Recruiting
Canisius Wilhelmina Ziekenhuis
Nijmegen
J. Janssen
- Recruiting
Bravis Ziekenhuis
Roosendaal
S. Boudewijns
- Recruiting
Ikazia Ziekenhuis
Rotterdam
F.E. de Jongh
- Recruiting
Haaglanden MC
The Hague
F.J.F. Jeurissen
- Recruiting
Bernhoven
Uden
J. van Extel
- Recruiting
Diakonessenhuis
Utrecht
L. van Leeuwen
- Recruiting
UMC Utrecht
Utrecht
Miriam Koopman
- Recruiting
Maxima Medisch Centrum
Veldhoven
L.H.J Simkens
- Recruiting
VieCuri Medisch Centrum
Venlo
J. Konsten
- Recruiting
St. Jans Gasthuis
Weert
N.A.J.B. Peters
About this study
Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design).
Patients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.
- Conditions
- Circulating Tumor DNA, Recurrence, Colon Cancer Stage II
- Being tested
- ctDNA analysis after surgery
- Medical subject headings
- Recurrence, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNA analysis after surgeryOther
ctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE.
| Study group | Role | What they receive |
|---|---|---|
| ctDNA-based treatment group | Experimental | Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. Results are reported to the treating physician and patients. All patients with detectable ctDNA are considered high risk stage 2 patients and will be offered adjuvant chemotherapy for 3 months (4 cycles CAPOX) according to routine clinical practice. Patients with undetectable ctDNA will receive routine follow-up at the surgical department. Receives: Other: ctDNA analysis after surgery |
| Standard of care group | No intervention | The treating physician and patient are not informed about the ctDNA result and these patients will receive routine follow-up at the surgical department. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood.
Measured: 8-12 weeks after surgery
Secondary outcomes (6)
Recurrence Rate
Proportion of patients that will experience disease recurrence
Measured: 2 and 5 years after surgery
Disease Free Survival rate
Proportion of patients that are alive and free of disease
Measured: 2 and 5 years after surgery
Disease-related Overall Survival rate
Proportion of patients that are alive
Measured: 5 years after surgery
Time to Recurrence
Measured: From date of randomization until the date of recurrence, assessed up to 5 years.
Quality of Life after treatment
Quality of Life (QoL) will be measured using questionnaires that are provided to patients who have given informed consent for the collection of questionnaires within PLCRC.
Comparison of QoL of the ctDNA positive patients in both study arms will be done using repeated measurements methods, including ACT as factor. QoL will also be analysed for the whole population in both arms of the study. Treatment differences at each QoL assessment time point will be compared by means of the Wilcoxon Rank Sum Test.
Measured: 10 years
Cost-effectiveness of the ctDNA-based treatment
The cost-effectiveness analysis will be carried out from a societal perspective, including both direct health care costs as well as indirect costs from productivity loss. The health outcome measure in the cost-effectiveness analysis will be the total quality adjusted life years (QALY) per group.
Measured: 5 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start5 Mar 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Tumor DNAStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 1,320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Personal Genome Diagnostics, The Netherlands Cancer Institute
- Responsible party
- Principal investigator, Miriam Koopman, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434896
- Sponsor's protocol ID
- NL71881.041.19
- Acronym
- CrEATE
- Status last verified
- May 2026
- First submitted
- 29 Apr 2024
- Last updated
- 12 May 2026
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
- ClinicalTrials.gov ID
- NCT06434896
- Acronym / sponsor ID
- CrEATE / NL71881.041.19
- Conditions
- Circulating Tumor DNA, Recurrence, Colon Cancer Stage II
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,320 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Personal Genome Diagnostics, The Netherlands Cancer Institute
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 May 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.
Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design).
Patients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| ctDNA-based treatment group | Experimental | Other: ctDNA analysis after surgeryPatients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. Results are reported to the treating physician and patients. All patients with detectable ctDNA are considered high risk stage 2 patients and will be offered adjuvant chemotherapy for 3 months (4 cycles CAPOX) according to routine clinical practice. Patients with undetectable ctDNA will receive routine follow-up at the surgical department. |
| Standard of care group | No intervention | –The treating physician and patient are not informed about the ctDNA result and these patients will receive routine follow-up at the surgical department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Informed consent for PLCRC with specific consent for:
- Histological confirmed stage II colon cancer
- Fit enough to receive treatment with combination chemotherapy (fluoropyrimidine and oxaliplatin) according to the treating physician
Key exclusion criteria (5 listed)
- Indication for adjuvant chemotherapy according to treating physician
- Another malignancy in previous 5 years, with the exception of treated carcinoma in situ or skin cancer other than melanoma
- Incomplete primary tumor resection (R1 or R2 resection)
- Contra-indication for fluoropyrimidines or oxaliplatin
- Pregnancy
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 |
|---|---|---|
| ctDNA analysis after surgeryctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE. | Other | ctDNA-based treatment group |
Primary outcome
Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood.
Time frame: 8-12 weeks after surgery
6 secondary outcomes
Recurrence Rate
Time frame: 2 and 5 years after surgery
Disease Free Survival rate
Time frame: 2 and 5 years after surgery
Disease-related Overall Survival rate
Time frame: 5 years after surgery
Time to Recurrence
Time frame: From date of randomization until the date of recurrence, assessed up to 5 years.
Quality of Life after treatment
Time frame: 10 years
Cost-effectiveness of the ctDNA-based treatment
Time frame: 5 years after diagnosis
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 12 May 2026.
- Individual participant dataSharing planned: No
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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.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ctDNA analysis after surgery in people with Circulating Tumor DNA and Recurrence, run by UMC Utrecht at 29 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 7 inclusion and 5 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 Miriam Koopman, Prof. dr. (+316 46 91 95 66, plcrcmedocc@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood. (time frame: 8-12 weeks after surgery). 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 12 May 2026.