A Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis
NCT ID: NCT05448703
Last Updated: 2022-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2021-02-25
2026-09-01
Brief Summary
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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.
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Detailed Description
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2. 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).
3. Detect serum proteins, gene expression profile, single-nucleotide polymorphisms, and epigenetic modifications that may be associated with radiation pneumonitis.
4. Screen biomarkers that are associated with radiation pneumonitis via univariate and multivariate Cox regression analysis.
5. Construct a predictive model of radiation pneumonitis based on clinical information, radiomics, and biomarkers via machine learning or Least absolute shrinkage and selection operator.
6. Use Kaplan-Meier and Cox model to analyze the association of radiation pneumonitis with survival and efficacy of antitumor treatment.
7. Identify biomarkers and predictors of other toxicities induced by radiotherapy including radiation esophagitis, cardiotoxicity and radiodermatitis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Lung cancer patients treated with thoracic radiotherapy
Blood Samples for Biomarkers
blood sample to be taken at baseline, during radiotherapy, and after radiotherapy
Interventions
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Blood Samples for Biomarkers
blood sample to be taken at baseline, during radiotherapy, and after radiotherapy
Eligibility Criteria
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Inclusion Criteria
2. Radiation dose at least 45 Gy
3. Karnofsky \>60
4. Age\>18
5. Life expectancy of at least 6 months
Exclusion Criteria
2. Severe cardiopulmonary diseases
18 Years
ALL
No
Sponsors
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Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology
UNKNOWN
Jingjiang People' Hospital
UNKNOWN
Huazhong University of Science and Technology
OTHER
Responsible Party
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Xianglin Yuan
Professor, Chief Physician
Principal Investigators
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Xianglin Yuan, PhD
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Locations
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Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Jingjiang People' Hospital
Jingjiang, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TJCC012
Identifier Type: -
Identifier Source: org_study_id
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