Radiation PneumonitisNCT05448703
A Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis
An observational study of Radiation Pneumonitis, run by Huazhong University of Science and Technology at 3 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Pneumonitis
- What is being tested?
- Blood Samples for Biomarkers
- How many people
- 300 participants
- Where
- 3 sitesChina
- Study dates
- 25 Feb 2021to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung cancer patients treated with thoracic radiotherapy.
Who may be able to join
- Clinical diagnosis of lung cancer by histology
- Radiation dose at least 45 Gy
- Karnofsky >60
- Age>18
- Life expectancy of at least 6 months
Who cannot join
- Previous thoracic irradiation
- Severe cardiopulmonary diseases
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Jingjiang People' Hospital
Jingjiang, Jiangsu, 214500
Dewen Wang, Bachelor, +8613815985599, jsjjwdw@163.com
Lihua Fan, MD, +8613852619599, 980692748@qq.com
- Recruiting
Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 43000
Guang Han, PhD, +8613886048178, hg7913@hotmail.com
Ying Li, MD, +8613628635363, hbwhw08@163.com
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Xianglin Yuan, PhD, +8613667241722, yuanxianglin@hust.edu.cn
Lingyan Xiao, MD, +8615971474885, lingyan.xiao123@gmail.com
About this study
Official title: A Multicenter Prospective Observational 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.
Read the detailed description
- 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.
- Conditions
- Radiation Pneumonitis
- Being tested
- Blood Samples for Biomarkers
- Medical subject headings
- Radiation Pneumonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Samples for BiomarkersOther
blood sample to be taken at baseline, during radiotherapy, and after radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Lung cancer patients treated with thoracic radiotherapy Receives: Other: Blood Samples for Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation pneumonitis
radiation pneumonitis grade >=2 or 3 graded by CTCAE4.0. [Time Frame: 12 months after radiotherapy]
Measured: 12 months after radiotherapy
Overall Survival
A long-term follow up will be scheduled to allow a complete survival analysis.
Measured: 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.
Measured: 5 years after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start25 Feb 2021
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation PneumonitisStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Hubei Cancer Hospital, Jingjiang People' Hospital
- Responsible party
- Principal investigator, Xianglin Yuan, Huazhong University of Science and Technology
- Investigators
- Xianglin Yuan, PhD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448703
- Sponsor's protocol ID
- TJCC012
- Status last verified
- Oct 2022
- First submitted
- 1 Jul 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Observational Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis
- ClinicalTrials.gov ID
- NCT05448703
- Acronym / sponsor ID
- TJCC012
- Conditions
- Radiation Pneumonitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Hubei Cancer Hospital, Jingjiang People' Hospital
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Blood Samples for BiomarkersLung cancer patients treated with thoracic radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients treated with thoracic radiotherapy.
Key inclusion criteria (5 listed)
- Clinical diagnosis of lung cancer by histology
- Radiation dose at least 45 Gy
- Karnofsky >60
- Age>18
- Life expectancy of at least 6 months
Key exclusion criteria (2 listed)
- Previous thoracic irradiation
- Severe cardiopulmonary diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Samples for Biomarkersblood sample to be taken at baseline, during radiotherapy, and after radiotherapy | Other | Group 1 |
Primary outcome
Radiation pneumonitis
Time frame: 12 months after radiotherapy
radiation pneumonitis grade >=2 or 3 graded by CTCAE4.0. [Time Frame: 12 months after radiotherapy]
Overall Survival
Time frame: 5 years after radiotherapy
A long-term follow up will be scheduled to allow a complete survival analysis.
1 secondary outcome
Other injuries induced by radiotherapy
Time frame: 5 years after radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianglin Yuan, PhD principal investigator
Tongji Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Pneumonitis, run by Huazhong University of Science and Technology at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xianglin Yuan, PhD (+8613667241722, yuanxianglin@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation pneumonitis (time frame: 12 months after radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.