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NCT Number: NCT04334239

Effectiveness of Care in Certified Cancer Centres in Germany

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.

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Key information

Conditions

Colorectal Cancer Adnexal Diseases Breast Cancer Breast Diseases Breast Neoplasms Bronchial Cancer Bronchial Neoplasms CNS Tumor Carcinoma, Bronchogenic Central Nervous System Neoplasms Cervix Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Neoplasms Head and Neck Tumor Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Technische Universität Dresden

Dresden, Saxony, 01307, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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]

Exclusion criteria

  • 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

Treatment and study plan

Oncological certification

Other

Oncological certification encompasses a variety of criteria such as treatment according to the clinical guidelines, staffing, technical infrastructure, minimum caseloads, and multidisciplinary care.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

    2-, 3-, 4-year survival after first hospitalization due to cancer

  2. Recurrence-free survival

    Time frame: cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017

    Recurrence-free survival after cancer diagnosis

  3. Cumulative recurrence rate

    Time frame: cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017

    Cumulative recurrence rate after cancer diagnosis

  4. Complications due to surgery

    Time frame: date of initial cancer surgery with entity-specific follow-up

    Complications due to cancer surgery

  5. Successive resection

    Time frame: second resection within three months of initial cancer surgery

    Second resection due to cancer

  6. Entity-specific outcomes defined by clinical experts

    Time frame: 2009-2017 [CCR] or 2006-2017 [WIdO]

    • Fractions of entity-specific surgery techniques
    • For head-neck-tumours: aspiration pneumonia due to swallowing dysfunctions

  7. Fraction of patients

    Time frame: 2009-2017

    Fraction of patients in certified centres and in non-certified hospitals over time

  8. Regional differences

    Time frame: 2009-2017

    Differences across outcomes in different counties or federal states

  9. Differences in patient characteristics

    Time frame: 2009-2017 [CCR] or 2006-2017 [WIdO]

    Differences in demographic characteristics, disease severity and risk factors across certified centres/non-certified hospitals

  10. Pathways of treatment

    Time frame: 2009-2017

    Patient's treatment pathways among general practitioners, specialists, and hospitals w.r.t. certification

  11. Severity Levels in insurance data

    Time frame: 2009-2017

    Deduction of cancer severity levels through linkage of health insurance and cancer registry data

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • Arbeitsgemeinschaft Deutscher Tumorzenten e.V., ADT
  • Tumorzentrum Regensburg, Institut für Qualitätssicherung und Versorgungsforschung, Universität Regensburg
  • Wissenschaftliches Institut der AOK (WIdO)

Registry information

Official study title

Wirksamkeit Der Versorgung in Onkologischen Zentren

Acronym: WiZen

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 6, 2020
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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