NCT07188116

Brief Summary

This study was designed as a single-center retrospective analysis aimed at investigating whether COVID-19 infection increases the risk or burden of radiation-induced pneumonitis in breast cancer patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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

September 15, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2025

Completed
3 months 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

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

September 22, 2025

Last Update Submit

September 22, 2025

Conditions

Keywords

Retrospective AnalysisCOVID-19Radiation PneumonitisPropensity Score MatchingBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • Radiation Pneumonitis Situation

    The incidence rate, severity and onset time of radiation pneumonitis

    From January 2021 to June 2024

Study Arms (2)

Without COVID-19

No COVID-19 infection

Other: COVID-19

With COVID-19

With COVID-19 infection

Other: COVID-19

Interventions

The COVID-19 infection situation was used as an intervention measure, and the cohort was divided into groups.

With COVID-19Without COVID-19

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Breast cancer patients who underwent radiotherapy at the Cancer Center of Zhejiang Hospital between January 1, 2021, and June 30, 2024, were screened for eligibility.

You may qualify if:

  • patients with pathologically or cytologically confirmed primary breast cancer,
  • aged 18 years or older but younger than 80 years,
  • with complete and reliable medical records,
  • for those with COVID-19 infection, documented evidence of a positive test result.

You may not qualify if:

  • concomitant pulmonary malignancies,
  • a history of prior thoracic radiotherapy,
  • concurrent pulmonary infections other than COVID-19 during radiotherapy,
  • missing key data with loss to follow-up,
  • or any other condition considered unsuitable for enrollment by the investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Hospital, Department of Oncology, Hangzhou, China, 310030

Hangzhou, Zhejiang, 310030, China

Location

MeSH Terms

Conditions

Breast NeoplasmsRadiation PneumonitisCOVID-19

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesLung InjuryRadiation InjuriesWounds and InjuriesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

September 22, 2025

First Posted

September 23, 2025

Study Start

September 15, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations