NCT05192876

Brief Summary

Analysis of outcomes and adverse events of patients undergoing radiation therapy. Quality control using data base of patient records 2000-2025

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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, 2000

Completed
21.6 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

26 years

First QC Date

August 4, 2021

Last Update Submit

May 17, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Overall survival (OS) and progression free survival (PFS) analysis after radiation therapy

    Calculation of Overall survival (OS) and progression free survival (PFS). Time-to-event endpoints are summarized as the median and corresponding 95% confidence interval using Kaplan-Meier method

    25 years

  • Analysis of risk factors influencing outcome after radiation therapy

    Calculation of log-rank tests. If possible, hazard ratios are calculated via Cox regression. Competing risk analysis is conducted as supportive analysis

    25 years

Secondary Outcomes (1)

  • Number of patients with acute and late adverse events after radiation therapy

    25 years

Study Arms (1)

Data Base of Patient Records 2000-2025

Analysis of outcomes and adverse events

Radiation: Radiotherapy

Interventions

RadiotherapyRADIATION

Outcomes and adverse events using radiation therapy

Data Base of Patient Records 2000-2025

Eligibility Criteria

Age16 Years - 105 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are being treated with radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital

You may qualify if:

  • Patients who are being treated with radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital

You may not qualify if:

  • No radiotherapy at the Department of Radiation Oncology at the Winterthur Cantonal Hospital \<16 years,\> 105 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

RECRUITING

Related Publications (1)

  • Windisch P, Becker I, Tang H, Schroder C, Buchali A, Aebersold DM, Zwahlen DR, Forster R, Shelan M. Converting between the International Prostate Symptom Score (IPSS) and the Expanded Prostate Cancer Index Composite (EPIC) urinary subscales: modeling and external validation. BMC Urol. 2024 Feb 3;24(1):28. doi: 10.1186/s12894-024-01421-y.

MeSH Terms

Conditions

Radiation Injuries

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Daniel Zwahlen, MD, MBA

    Kantonsspital Winterthur KSW

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel R Zwahlen, MD, MBA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Department of Radiation Oncology

Study Record Dates

First Submitted

August 4, 2021

First Posted

January 14, 2022

Study Start

January 1, 2000

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations