Colorectal Cancer (CRC) and Pancreatic Cancer (PaCa)NCT05479292
Allocating Resources for Cancer Care in Times of the Sars-CoV-2 Outbreak. Health Care Research
An observational study of Colorectal Cancer (CRC) and Pancreatic Cancer (PaCa), run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The focus on treatment of COVID19 patients during the Sars-CoV-2 outbreak has most likely implications for the extent and quality of diagnosis and treatment of non-COVID19 patients. Medical care of cancer patients is a particularly sensitive area. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Colorectal Cancer (CRC) and Pancreatic Cancer (PaCa)
- What is being tested?
- Sars-CoV-2 outbreak
- How many people
- 6,500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2019to 31 Dec 2020
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Residents of Saxony, Germany with continuous health insurance coverage provided by the AOK PLUS from 2015 - 2020 with a diagnosis of colorectal cancer, pancreatic cancer, type 2 diabetes, coronary heart disease or multiple sclerosis in 2019 or 2020 according to ICD-10
Who may be able to join
- Resident of Saxony, Germany with health insurance coverage provided by AOK PLUS
- Diagnosis of colorectal cancer, pancreatic cancer, type 2 diabetes, coronary heart disease or multiple sclerosis between in 2019 or 2020 according to ICD-10
Who cannot join
- Change of health insurance provider between 2015 and 2020
- Born after 2014
- Deceased between 2015-2018
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical Care of Cancer Patients During the COVID-19 Pandemic - an Analysis of Health Insurance Claims Data
The focus on treatment of COVID19 patients during the Sars-CoV-2 outbreak has most likely implications for the extent and quality of diagnosis and treatment of non-COVID19 patients. Medical care of cancer patients is a particularly sensitive area. To draw holistic conclusions, it is necessary to analyze the provision of healthcare as broadly as possible with regard to the dimensions of access, processes and outcome during the Sars-CoV-2 pandemic. This will be implemented exemplarily for the early detection, diagnosis and treatment of colorectal cancer (CRC) and pancreatic cancer (PaCa) in Saxony. Patients with diagnosis, treatment or early detection measures for type 2 diabetes (T2D), coronary heart disease (CHD) and multiple sclerosis (MS) serve as comparison groups.
Read the detailed description
For a realistic assessment, the situation will be compared with the situation before the Sars-CoV-2 pandemic while considering confounders and effect modifiers. The evaluation is based on pseudonymised routine statutory health insurance (SHI) data of the AOK PLUS for Saxony.
As data sources, SHI data of the AOK PLUS Saxony for the period 2015 to 4th quarter 2020 and publicly available data on COVID19 are used. The differentiation between incidence and prevalent diseases is based on a 4-year washout period, so that the health care situation can be compared between 2019 (pre-period) and 2020 (post-period). Patients with confirmed diagnoses of CRC and PaCa or early detection measures regarding CRC are investigated. These will be contrasted to patients with confirmed diagnoses of T2D, CHD, and MS or early detection measures regarding T2D.
The differentiation of subgroups as confounders or effect modifiers is taken into account. Subgroups are considered with respect to the factors age groups, gender, Elixhauser comorbidities, metastasis y/n, residential regions (postal code 3 digits), characteristics of the treating institution and possibly seasonal effects.
Aims:
Analysis of the differences in the health care provision situation during the Sars-CoV-2 outbreak compared to the time before.
Research questions:
- (How) did the situation of health care for cancer patients change due to the outbreak of Sars-CoV-2? Which changes could be observed in the dimensions access to care, quality or guideline adherence in medical care and outcome?
- Did the focus on COVID19 patients have an impact on the diagnosis or early detection of cancer in Saxony?
- Are the observed effects differential with respect to the diseases, especially when comparing CRC and PaCa with the control group regarding T2D and CHD?
- Being tested
- Sars-CoV-2 outbreak
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sars-CoV-2 outbreakOther
Sars-CoV-2 pandemic's impact on provision of healthcare for cancer patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of confirmed diagnoses (new cases of CRC or PaCa)
Measured: Comparison of 2019 to 2020
Number of colonoscopies
Measured: Comparison of 2019 to 2020
Secondary outcomes (2)
Number of hospitalizations
Measured: Comparison of 2019 to 2020
Number of surgeries/systemic therapies related to cancer after onset of disease
Measured: Comparison of 2019 to 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Jan 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC) and Pancreatic Cancer (PaCa)Studies 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
- 6,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, AOK PLUS, Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg, Ruhr University of Bochum
- Responsible party
- Sponsor
- Investigators
- Jochen Schmitt, Dr. med., Principal investigator, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479292
- Sponsor's protocol ID
- CancerCOVID-HCR
- Status last verified
- Jul 2022
- First submitted
- 28 Jul 2022
- Last updated
- 29 Jul 2022
- 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 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Care of Cancer Patients During the COVID-19 Pandemic - an Analysis of Health Insurance Claims Data
- ClinicalTrials.gov ID
- NCT05479292
- Acronym / sponsor ID
- CancerCOVID-HCR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,500 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, AOK PLUS, Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg, Ruhr University of Bochum
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Jul 2022 (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 focus on treatment of COVID19 patients during the Sars-CoV-2 outbreak has most likely implications for the extent and quality of diagnosis and treatment of non-COVID19 patients. Medical care of cancer patients is a particularly sensitive area. To draw holistic conclusions, it is necessary to analyze the provision of healthcare as broadly as possible with regard to the dimensions of access, processes and outcome during the Sars-CoV-2 pandemic. This will be implemented exemplarily for the early detection, diagnosis and treatment of colorectal cancer (CRC) and pancreatic cancer (PaCa) in Saxony. Patients with diagnosis, treatment or early detection measures for type 2 diabetes (T2D), coronary heart disease (CHD) and multiple sclerosis (MS) serve as comparison groups.
Detailed description
For a realistic assessment, the situation will be compared with the situation before the Sars-CoV-2 pandemic while considering confounders and effect modifiers. The evaluation is based on pseudonymised routine statutory health insurance (SHI) data of the AOK PLUS for Saxony.
As data sources, SHI data of the AOK PLUS Saxony for the period 2015 to 4th quarter 2020 and publicly available data on COVID19 are used. The differentiation between incidence and prevalent diseases is based on a 4-year washout period, so that the health care situation can be compared between 2019 (pre-period) and 2020 (post-period). Patients with confirmed diagnoses of CRC and PaCa or early detection measures regarding CRC are investigated. These will be contrasted to patients with confirmed diagnoses of T2D, CHD, and MS or early detection measures regarding T2D.
The differentiation of subgroups as confounders or effect modifiers is taken into account. Subgroups are considered with respect to the factors age groups, gender, Elixhauser comorbidities, metastasis y/n, residential regions (postal code 3 digits), characteristics of the treating institution and possibly seasonal effects.
Aims:
Analysis of the differences in the health care provision situation during the Sars-CoV-2 outbreak compared to the time before.
Research questions:
- (How) did the situation of health care for cancer patients change due to the outbreak of Sars-CoV-2? Which changes could be observed in the dimensions access to care, quality or guideline adherence in medical care and outcome?
- Did the focus on COVID19 patients have an impact on the diagnosis or early detection of cancer in Saxony?
- Are the observed effects differential with respect to the diseases, especially when comparing CRC and PaCa with the control group regarding T2D and CHD?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents of Saxony, Germany with continuous health insurance coverage provided by the AOK PLUS from 2015 - 2020 with a diagnosis of colorectal cancer, pancreatic cancer, type 2 diabetes, coronary heart disease or multiple sclerosis in 2019 or 2020 according to ICD-10
Key inclusion criteria (2 listed)
- Resident of Saxony, Germany with health insurance coverage provided by AOK PLUS
- Diagnosis of colorectal cancer, pancreatic cancer, type 2 diabetes, coronary heart disease or multiple sclerosis between in 2019 or 2020 according to ICD-10
Key exclusion criteria (3 listed)
- Change of health insurance provider between 2015 and 2020
- Born after 2014
- Deceased between 2015-2018
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 |
|---|---|---|
| Sars-CoV-2 outbreakSars-CoV-2 pandemic's impact on provision of healthcare for cancer patients | Other | – |
Primary outcome
Number of confirmed diagnoses (new cases of CRC or PaCa)
Time frame: Comparison of 2019 to 2020
Number of colonoscopies
Time frame: Comparison of 2019 to 2020
2 secondary outcomes
Number of hospitalizations
Time frame: Comparison of 2019 to 2020
Number of surgeries/systemic therapies related to cancer after onset of disease
Time frame: Comparison of 2019 to 2020
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 29 Jul 2022.
- Individual participant dataSharing planned: No
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.
Jochen Schmitt, Dr. med. principal investigator
Technische Universität Dresden
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 (CRC) and Pancreatic Cancer (PaCa), 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 3 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 29 Jul 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?
Number of confirmed diagnoses (new cases of CRC or PaCa) (time frame: Comparison of 2019 to 2020). 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?
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 29 Jul 2022.