A Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHuazhong University of Science and Technology

About this trial

Radiation pneumonitis is the main dose-limiting toxicity of thoracic radiotherapy, which can affect life quality, survival, and the tumor-controlling effects of patients receiving thoracic radiotherapy.

The purpose of this study is to:

* Identify biomarkers including serum proteins, gene expression, genetic changes, and epigenetic modifications that determine radiation pneumonitis. * Investigate the relationship between radiation pneumonitis and other toxicities induced by radiotherapy. * Construct a predictive model for radiation pneumonitis. * Evaluate survival and treatment outcome of patients with radiation pneumonitis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of lung cancer by histology

Radiation dose at least 45 Gy

Karnofsky >60

Age>18

Disqualifiers

Previous thoracic irradiation

Severe cardiopulmonary diseases

Trial population

Lung cancer patients treated with thoracic radiotherapy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood Samples for Biomarkers

    Other intervention

    blood sample to be taken at baseline, during radiotherapy, and after radiotherapy

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Group 11 intervention

Trial outcomes

Primary outcomes

1

Radiation pneumonitis

radiation pneumonitis grade \>=2 or 3 graded by CTCAE4.0. \[Time Frame: 12 months after radiotherapy\]

Time frame
12 months after radiotherapy
2

Overall Survival

A long-term follow up will be scheduled to allow a complete survival analysis.

Time frame
5 years after radiotherapy

Secondary outcomes

1

Other injuries induced by radiotherapy

Assessment of other common injuries induced by thoracic radiotherapy including injuries in heart, skin, and esophagus according to CTCAE4.0.

Time frame
5 years after radiotherapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Huazhong University of Science and Technology

Lead sponsor

Hubei Cancer Hospital

Collaborator

Jingjiang People' Hospital

Collaborator