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NCT Number: NCT05448703

A Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

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About this study

  • Collect clinical information, CT images, and peripheral blood of the lung cancer patients treated with thoracic radiotherapy in Tongji Hospital, Hubei Cancer Hospital, and Jingjiang People's Hospital.
  • Follow up the enrolled patients. All patients enrolled in this study are examined during and one month after radiotherapy. Then, the patients are followed every three months for the first year and every six months thereafter. At each follow-up visits, all patients are asked to undergo a chest CT, and information including survival status, symptoms, CT images, and treatment is collected. Radiation pneumonitis and other toxicities induced by radiotherapy are graded by two radiation oncologists according to the Common Terminology Criteria for Adverse Events 4.0 (CTCAE4.0).
  • Detect serum proteins, gene expression profile, single-nucleotide polymorphisms, and epigenetic modifications that may be associated with radiation pneumonitis.
  • Screen biomarkers that are associated with radiation pneumonitis via univariate and multivariate Cox regression analysis.
  • Construct a predictive model of radiation pneumonitis based on clinical information, radiomics, and biomarkers via machine learning or Least absolute shrinkage and selection operator.
  • Use Kaplan-Meier and Cox model to analyze the association of radiation pneumonitis with survival and efficacy of antitumor treatment.
  • Identify biomarkers and predictors of other toxicities induced by radiotherapy including radiation esophagitis, cardiotoxicity and radiodermatitis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of lung cancer by histology
  • Radiation dose at least 45 Gy
  • Karnofsky >60
  • Age>18
  • Life expectancy of at least 6 months

Exclusion criteria

  • Previous thoracic irradiation
  • Severe cardiopulmonary diseases

Treatment and study plan

Blood Samples for Biomarkers

Other

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

Primary outcomes

  1. Radiation pneumonitis

    Time frame: 12 months after radiotherapy

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

  2. Overall Survival

    Time frame: 5 years after radiotherapy

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

Secondary outcomes

  1. Other injuries induced by radiotherapy

    Time frame: 5 years after radiotherapy

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lingyan Xiao, MD

CONTACT

[email protected]

+8615971474885

Xianglin Yuan, PhD

CONTACT

[email protected]

+8613667241722

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Collaborators

  • Hubei Cancer Hospital
  • Jingjiang People' Hospital

Registry information

Official study title

A Multicenter Prospective Observational Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2022
Registry last updated
Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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