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| Name | Class |
|---|---|
| Personal Genome Diagnostics | INDUSTRY |
| The Netherlands Cancer Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ctDNA analysis after surgery | Other | ctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood. | 8-12 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Rate | Proportion of patients that will experience disease recurrence | 2 and 5 years after surgery |
| Disease Free Survival rate | Proportion of patients that are alive and free of disease |
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Inclusion Criteria:
Age ≥ 18 years
Informed consent for PLCRC with specific consent for:
Inclusion in observational PLCRC -MEDOCC substudy
Histological confirmed stage II colon cancer
Fit enough to receive treatment with combination chemotherapy (fluoropyrimidine and oxaliplatin) according to the treating physician
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miriam Koopman, Prof. dr. | Contact | +316 46 91 95 66 | plcrcmedocc@umcutrecht.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeroen Bosch Ziekenhuis | Recruiting | 's-Hertogenbosch | Netherlands |
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Randomized controlled trial
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| 2 and 5 years after surgery |
| Disease-related Overall Survival rate | Proportion of patients that are alive | 5 years after surgery |
| Time to Recurrence | 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. | 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. | 5 years after diagnosis |
| Noordwest Ziekenhuisgroep | Recruiting | Alkmaar | Netherlands |
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| Ziekenhuisgroep Twente | Recruiting | Almelo | Netherlands |
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| Flevoziekenhuis | Recruiting | Almere Stad | Netherlands |
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| Meander Medisch Centrum | Recruiting | Amersfoort | Netherlands |
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| NKI-AVL | Recruiting | Amsterdam | Netherlands |
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| Rijnstate | Recruiting | Arnhem | Netherlands |
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| Amphia Ziekenhuis | Recruiting | Breda | Netherlands |
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| Reinier de Graaf Gasthuis | Recruiting | Delft | Netherlands |
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| Deventer Ziekenhuis | Recruiting | Deventer | Netherlands |
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| Albert Schweizer Ziekenhuis | Recruiting | Dordrecht | Netherlands |
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| Ziekenhuis Gelderse Vallei | Recruiting | Ede | Netherlands |
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| Admiraal de Ruyter Ziekenhuis | Recruiting | Goes | Netherlands |
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| Rivas | Recruiting | Gorinchem | Netherlands |
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| Spaarne Gasthuis | Recruiting | Haarlem | Netherlands |
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| Ziekenhuis St. Jansdal | Recruiting | Harderwijk | Netherlands |
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| Maastricht UMC | Recruiting | Maastricht | Netherlands |
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| Van Weel-Bethesda Ziekenhuis | Recruiting | Middelharnis | Netherlands |
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| St. Antonius Ziekenhuis | Recruiting | Nieuwegein | Netherlands |
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| Canisius Wilhelmina Ziekenhuis | Recruiting | Nijmegen | Netherlands |
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| Bravis Ziekenhuis | Recruiting | Roosendaal | Netherlands |
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| Ikazia Ziekenhuis | Recruiting | Rotterdam | Netherlands |
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| Haaglanden MC | Recruiting | The Hague | Netherlands |
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| Bernhoven | Recruiting | Uden | Netherlands |
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| Diakonessenhuis | Recruiting | Utrecht | Netherlands |
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| UMC Utrecht | Recruiting | Utrecht | Netherlands |
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| Maxima Medisch Centrum | Recruiting | Veldhoven | Netherlands |
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| VieCuri Medisch Centrum | Recruiting | Venlo | Netherlands |
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| St. Jans Gasthuis | Recruiting | Weert | Netherlands |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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