Colorectal CancerWiZenNCT04334239
Effectiveness of Care in Certified Cancer Centres in Germany
An observational study of Colorectal Cancer and Breast Cancer, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Assessment of the effectiveness of care in certified cancer centres for eight cancer entities via a retrospective cohort study based on secondary data from statutory health insurance funds and population-based clinical cancer registries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Breast Cancer, Ovarian Cancer
- What is being tested?
- Oncological certification
- How many people
- 670,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2017to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: German residents with continuous insurance of one of the AOK funds 2006-2017 and patients recorded in one of the participating cancer registries Dresden, Erfurt, Regensburg and Berlin-Brandenburg 2006-2017
Who may be able to join
- first hospitalization due to diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2009-2017 [WIdO]
- hospitalization due to primary diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2006-2017 [CCR]
Who cannot join
- prevalent diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2006-2017
- exception: outpatient cancer diagnosis up to 12 months prior to first hospitalization is not regarded as prevalent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wirksamkeit Der Versorgung in Onkologischen Zentren
Assessment of the effectiveness of care in certified cancer centres for eight cancer entities via a retrospective cohort study based on secondary data from statutory health insurance funds and population-based clinical cancer registries.
Read the detailed description
Cancer constitutes the second most frequent cause of death in Germany. To maintain a high quality of treatment, the national cancer plan aims at a unified certification of cancer centres.
The project "Wirksamkeit der Versorgung in onkologischen Zentren" (WiZen) investigates effects of treatments in certified cancer centres across large populations and different cancer entities in comparison to hospitals that do not hold a certificate.
WiZen is a retrospective comparative cohort study that analyzes incident cases of eight types of cancer diagnosed within 2009-2017 based on nationwide health insurance data provided by WIdO (the AOK research institute) and data from regional clinical cancer registries (CCR) for the period 2006-2017. These eight types of cancer are colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors and neuro-oncological tumors.
- Conditions
- Colorectal Cancer, Breast Cancer, Ovarian Cancer, Cervix Cancer, Endometrial Cancer, Bronchial Cancer
- Being tested
- Oncological certification
- Keywords
- quality of treatment, institution of treatment, certification, cancer centres, quality of care, treatment outcome, health services research
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Carcinoma, Bronchogenic, Prostatic Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncological certificationOther
Oncological certification encompasses a variety of criteria such as treatment according to the clinical guidelines, staffing, technical infrastructure, minimum caseloads, and multidisciplinary care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Cancer patients who have undergone substantial parts of inpatient treatment in a certified cancer centre. Receives: Other: Oncological certification | |
| Control | Cancer patients who have not undergone inpatient treatment in a certified cancer centre. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Survival after first hospitalization due to cancer
Measured: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017
1- and 5-year survival
1- and 5-year survival after first hospitalization due to cancer
Measured: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 1 or 5-year follow-up, respectively
30-day mortality
30-day mortality after first hospitalization due to cancer
Measured: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 30 days follow-up
Secondary outcomes (11)
2-, 3-, 4-year survival
2-, 3-, 4-year survival after first hospitalization due to cancer
Measured: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 2,3, or 4-year follow-up, respectively
Recurrence-free survival
Recurrence-free survival after cancer diagnosis
Measured: cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017
Cumulative recurrence rate
Cumulative recurrence rate after cancer diagnosis
Measured: cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017
Complications due to surgery
Complications due to cancer surgery
Measured: date of initial cancer surgery with entity-specific follow-up
Successive resection
Second resection due to cancer
Measured: second resection within three months of initial cancer surgery
Entity-specific outcomes defined by clinical experts
- Fractions of entity-specific surgery techniques
- For head-neck-tumours: aspiration pneumonia due to swallowing dysfunctions
Measured: 2009-2017 [CCR] or 2006-2017 [WIdO]
Fraction of patients
Fraction of patients in certified centres and in non-certified hospitals over time
Measured: 2009-2017
Regional differences
Differences across outcomes in different counties or federal states
Measured: 2009-2017
Differences in patient characteristics
Differences in demographic characteristics, disease severity and risk factors across certified centres/non-certified hospitals
Measured: 2009-2017 [CCR] or 2006-2017 [WIdO]
Pathways of treatment
Patient's treatment pathways among general practitioners, specialists, and hospitals w.r.t. certification
Measured: 2009-2017
Severity Levels in insurance data
Deduction of cancer severity levels through linkage of health insurance and cancer registry data
Measured: 2009-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start1 May 2017
- Primary completion31 May 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- Retrospective
- Enrolment
- 670,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Tumorzentrum Regensburg, Institut für Qualitätssicherung und Versorgungsforschung, Universität Regensburg, Arbeitsgemeinschaft Deutscher Tumorzenten e.V., ADT, Wissenschaftliches Institut der AOK (WIdO)
- Responsible party
- Principal investigator, Jochen Schmitt., Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334239
- Sponsor's protocol ID
- 01VSF17020
- Acronym
- WiZen
- Status last verified
- Aug 2022
- First submitted
- 31 Mar 2020
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hansinger J, Schoffer O, Volkel V, Gerken M, Wimberger P, Bierbaum V, Bobeth C, Rossler M, Droge P, Ruhnke T, Gunster C, Kleihues-van Tol K, Link T, Kast K, Papathemelis T, Ortmann O, Schmitt J, Klinkhammer-Schalke M. Comparison of survival in ovarian cancer patients following treatment in certified gynecologic oncology centers and non-certified hospitals: a German retrospective cohort study (WiZen). J Ovarian Res. 2025 Nov 4;18(1):238. doi: 10.1186/s13048-025-01843-8.
PubMed 41188998Roessler M, Schmitt J, Bobeth C, Gerken M, Kleihues-van Tol K, Reissfelder C, Rau BM, Distler M, Piso P, Gunster C, Klinkhammer-Schalke M, Schoffer O, Bierbaum V. Is treatment in certified cancer centers related to better survival in patients with pancreatic cancer? Evidence from a large German cohort study. BMC Cancer. 2022 Jun 7;22(1):621. doi: 10.1186/s12885-022-09731-w.
PubMed 35672675
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wirksamkeit Der Versorgung in Onkologischen Zentren
- ClinicalTrials.gov ID
- NCT04334239
- Acronym / sponsor ID
- WiZen / 01VSF17020
- Conditions
- Colorectal Cancer, Breast Cancer, Ovarian Cancer, Cervix Cancer, Endometrial Cancer, Bronchial Cancer
- Keywords
- quality of treatment, institution of treatment, certification, cancer centres, quality of care, treatment outcome, health services research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 670,000 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Tumorzentrum Regensburg, Institut für Qualitätssicherung und Versorgungsforschung, Universität Regensburg, Arbeitsgemeinschaft Deutscher Tumorzenten e.V., ADT, Wissenschaftliches Institut der AOK (WIdO)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 6 Apr 2020 (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.
Assessment of the effectiveness of care in certified cancer centres for eight cancer entities via a retrospective cohort study based on secondary data from statutory health insurance funds and population-based clinical cancer registries.
Detailed description
Cancer constitutes the second most frequent cause of death in Germany. To maintain a high quality of treatment, the national cancer plan aims at a unified certification of cancer centres.
The project "Wirksamkeit der Versorgung in onkologischen Zentren" (WiZen) investigates effects of treatments in certified cancer centres across large populations and different cancer entities in comparison to hospitals that do not hold a certificate.
WiZen is a retrospective comparative cohort study that analyzes incident cases of eight types of cancer diagnosed within 2009-2017 based on nationwide health insurance data provided by WIdO (the AOK research institute) and data from regional clinical cancer registries (CCR) for the period 2006-2017. These eight types of cancer are colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors and neuro-oncological tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: Oncological certificationCancer patients who have undergone substantial parts of inpatient treatment in a certified cancer centre. |
| Control | – | –Cancer patients who have not undergone inpatient treatment in a certified cancer centre. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- German residents with continuous insurance of one of the AOK funds 2006-2017 and patients recorded in one of the participating cancer registries Dresden, Erfurt, Regensburg and Berlin-Brandenburg 2006-2017
Key inclusion criteria (2 listed)
- first hospitalization due to diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2009-2017 [WIdO]
- hospitalization due to primary diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2006-2017 [CCR]
Key exclusion criteria (2 listed)
- prevalent diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2006-2017
- exception: outpatient cancer diagnosis up to 12 months prior to first hospitalization is not regarded as prevalent
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 |
|---|---|---|
| Oncological certificationOncological certification encompasses a variety of criteria such as treatment according to the clinical guidelines, staffing, technical infrastructure, minimum caseloads, and multidisciplinary care. | Other | Intervention |
Primary outcome
Overall survival
Time frame: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017
Survival after first hospitalization due to cancer
1- and 5-year survival
Time frame: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 1 or 5-year follow-up, respectively
1- and 5-year survival after first hospitalization due to cancer
30-day mortality
Time frame: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 30 days follow-up
30-day mortality after first hospitalization due to cancer
11 secondary outcomes
2-, 3-, 4-year survival
Time frame: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 2,3, or 4-year follow-up, respectively
Recurrence-free survival
Time frame: cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017
Cumulative recurrence rate
Time frame: cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017
Complications due to surgery
Time frame: date of initial cancer surgery with entity-specific follow-up
Successive resection
Time frame: second resection within three months of initial cancer surgery
Entity-specific outcomes defined by clinical experts
Time frame: 2009-2017 [CCR] or 2006-2017 [WIdO]
Fraction of patients
Time frame: 2009-2017
Regional differences
Time frame: 2009-2017
Differences in patient characteristics
Time frame: 2009-2017 [CCR] or 2006-2017 [WIdO]
Pathways of treatment
Time frame: 2009-2017
Severity Levels in insurance data
Time frame: 2009-2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Derived from this study: PubMed 41188998Hansinger J, Schoffer O, Volkel V, Gerken M, Wimberger P, Bierbaum V, Bobeth C, Rossler M, Droge P, Ruhnke T, Gunster C, Kleihues-van Tol K, Link T, Kast K, Papathemelis T, Ortmann O, Schmitt J, Klinkhammer-Schalke M. Comparison of survival in ovarian cancer patients following treatment in certified gynecologic oncology centers and non-certified hospitals: a German retrospective cohort study (WiZen). J Ovarian Res. 2025 Nov 4;18(1):238. doi: 10.1186/s13048-025-01843-8.
- Derived from this study: PubMed 35672675Roessler M, Schmitt J, Bobeth C, Gerken M, Kleihues-van Tol K, Reissfelder C, Rau BM, Distler M, Piso P, Gunster C, Klinkhammer-Schalke M, Schoffer O, Bierbaum V. Is treatment in certified cancer centers related to better survival in patients with pancreatic cancer? Evidence from a large German cohort study. BMC Cancer. 2022 Jun 7;22(1):621. doi: 10.1186/s12885-022-09731-w.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Colorectal Cancer and Breast Cancer, run by Technische Universität Dresden at 1 site in Germany.
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 2 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: finished, as of the sponsor's last update on 23 Aug 2022. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017). The study lists 3 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 NCT04334239, which also lists 2 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 23 Aug 2022.