NCT05479292

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

July 28, 2022

Last Update Submit

July 28, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of confirmed diagnoses (new cases of CRC or PaCa)

    Comparison of 2019 to 2020

  • Number of colonoscopies

    Comparison of 2019 to 2020

Secondary Outcomes (2)

  • Number of hospitalizations

    Comparison of 2019 to 2020

  • Number of surgeries/systemic therapies related to cancer after onset of disease

    Comparison of 2019 to 2020

Other Outcomes (1)

  • Pathway of health care

    Comparison of 2019 to 2020

Interventions

Sars-CoV-2 pandemic's impact on provision of healthcare for cancer patients

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • Change of health insurance provider between 2015 and 2020
  • Born after 2014
  • Deceased between 2015-2018

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZEGV

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Conditions

Colorectal NeoplasmsPancreatic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Jochen Schmitt, Dr. med.

    Technische Universität Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2022

First Posted

July 29, 2022

Study Start

January 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations