Radiation PneumonitisNCT02490319
Study on the Biological Prediction Models of Radiation Pneumonitis
An observational study of Radiation Pneumonitis, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Radiation pneumonitis is the most common complication and the major dose-limiting toxicity associated with radiotherapy, which can cause poor quality of life or life-threatening symptoms and might hinder the tumor-controlling effects of radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiation Pneumonitis
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Sep 2008to Jul 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung cancer patients treated with radiation therapy at Tongji Hospital, Huazhong University of Science and Technology (Wuhan, Hubei Province, China).
Who may be able to join
- Clinical diagnosis of lung cancer by histology
- Radiation dose at least 45 Gy
- KPS>60
- Life expectancy of at least 6 months
- Voluntarily signed the informed consent
Who cannot join
- Previous thoracic irradiation
- Severe cardiopulmonary diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Oncology, Tongji Hospital
Wuhan, Hubei, 430030
Xianglin Yuan, MD, PhD, 13667241722, yxl@medmail.com.cn
Yang Tang, MD, PhD, 18627182062, tangyangtjmu@126.com
About this study
Radiation pneumonitis is the most common complication and the major dose-limiting toxicity associated with radiotherapy, which can cause poor quality of life or life-threatening symptoms and might hinder the tumor-controlling effects of radiotherapy. Consequently, establishing reliable predictors for the occurrence of RP is of great significance such that the therapeutic effects of RT can be maximized while minimizing its adverse effects. The aim of this study is to figure out the biological prediction models of radiation pneumonitis.
Read the detailed description
- Establish a clinical data base for the lung cancer patients treated with radiotherapy in Tongji Hospital. Data including age, gender, smoking state, KPS, pulmonary function, disease history, histology, stage, surgery, chemotherapy, dosimetric parameters of radiotherapy were collected. Peripheral blood was collected from all patients enrolled. 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 X-ray or CT and clinical information, including symptoms, is collected. RP is graded by two radiation oncologists according to the Common Terminology Criteria for Adverse Events 4.0.
- Select candidate genes and pathways which may be associated with radiation pneumonitis and identify their tagSNPs by Haploview.
- Use Kaplan-Meier and Cox model to analyze the association of all the factors collected with radiation pneumonitis.
- Establish a biological prediction models for radiation pneumonitis based on the statistics analysis
- Conditions
- Radiation Pneumonitis
- Keywords
- radiation pneumonitis, lung cancer, prediction models, genetic variants
- Medical subject headings
- Radiation Pneumonitis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Lung cancer patients treated with thoracic radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiation pneumonitis grade >=2 or 3
Measured: 12 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startSep 2008
- Primary completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Responsible party
- Principal investigator, Xianglin Yuan, Huazhong University of Science and Technology
- Investigators
- Xianglin Yuan, MD, PhD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490319
- Sponsor's protocol ID
- TJCC002
- Status last verified
- Oct 2022
- First submitted
- 1 Jul 2015
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Mehta V. Radiation pneumonitis and pulmonary fibrosis in non-small-cell lung cancer: pulmonary function, prediction, and prevention. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):5-24. doi: 10.1016/j.ijrobp.2005.03.047.
PubMed 15963660Marks LB, Bentzen SM, Deasy JO, Kong FM, Bradley JD, Vogelius IS, El Naqa I, Hubbs JL, Lebesque JV, Timmerman RD, Martel MK, Jackson A. Radiation dose-volume effects in the lung. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S70-6. doi: 10.1016/j.ijrobp.2009.06.091.
PubMed 20171521Yuan X, Liao Z, Liu Z, Wang LE, Tucker SL, Mao L, Wang XS, Martel M, Komaki R, Cox JD, Milas L, Wei Q. Single nucleotide polymorphism at rs1982073:T869C of the TGFbeta 1 gene is associated with the risk of radiation pneumonitis in patients with non-small-cell lung cancer treated with definitive radiotherapy. J Clin Oncol. 2009 Jul 10;27(20):3370-8. doi: 10.1200/JCO.2008.20.6763. Epub 2009 Apr 20.
PubMed 19380441Tang Y, Yang L, Qin W, Yi MX, Liu B, Yuan X. Impact of genetic variant of HIPK2 on the risk of severe radiation pneumonitis in lung cancer patients treated with radiation therapy. Radiat Oncol. 2020 Jan 8;15(1):9. doi: 10.1186/s13014-019-1456-0.
PubMed 31915028Tang Y, Yang L, Qin W, Yi M, Liu B, Yuan X. Validation study of the association between genetic variant of IL4 and severe radiation pneumonitis in lung cancer patients treated with radiation therapy. Radiother Oncol. 2019 Dec;141:86-94. doi: 10.1016/j.radonc.2019.09.002. Epub 2019 Sep 17.
PubMed 31540745Tang Y, Liu B, Li J, Wu H, Yang J, Zhou X, Yi M, Li Q, Yu S, Yuan X. Genetic variants in PI3K/AKT pathway are associated with severe radiation pneumonitis in lung cancer patients treated with radiation therapy. Cancer Med. 2016 Jan;5(1):24-32. doi: 10.1002/cam4.564. Epub 2015 Dec 8.
PubMed 26645682
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Biological Prediction Models of Radiation Pneumonitis
- ClinicalTrials.gov ID
- NCT02490319
- Acronym / sponsor ID
- TJCC002
- Conditions
- Radiation Pneumonitis
- Keywords
- radiation pneumonitis, lung cancer, prediction models, genetic variants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2023 (estimated)
- First posted
- 3 Jul 2015 (estimated)
- 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 most common complication and the major dose-limiting toxicity associated with radiotherapy, which can cause poor quality of life or life-threatening symptoms and might hinder the tumor-controlling effects of radiotherapy. Consequently, establishing reliable predictors for the occurrence of RP is of great significance such that the therapeutic effects of RT can be maximized while minimizing its adverse effects. The aim of this study is to figure out the biological prediction models of radiation pneumonitis.
Detailed description
- Establish a clinical data base for the lung cancer patients treated with radiotherapy in Tongji Hospital. Data including age, gender, smoking state, KPS, pulmonary function, disease history, histology, stage, surgery, chemotherapy, dosimetric parameters of radiotherapy were collected. Peripheral blood was collected from all patients enrolled. 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 X-ray or CT and clinical information, including symptoms, is collected. RP is graded by two radiation oncologists according to the Common Terminology Criteria for Adverse Events 4.0.
- Select candidate genes and pathways which may be associated with radiation pneumonitis and identify their tagSNPs by Haploview.
- Use Kaplan-Meier and Cox model to analyze the association of all the factors collected with radiation pneumonitis.
- Establish a biological prediction models for radiation pneumonitis based on the statistics analysis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Lung cancer patients treated with thoracic radiation therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients treated with radiation therapy at Tongji Hospital, Huazhong University of Science and Technology (Wuhan, Hubei Province, China).
Key inclusion criteria (5 listed)
- Clinical diagnosis of lung cancer by histology
- Radiation dose at least 45 Gy
- KPS>60
- Life expectancy of at least 6 months
- Voluntarily signed the informed consent
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.
Primary outcome
radiation pneumonitis grade >=2 or 3
Time frame: 12 months after radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Background: PubMed 15963660Mehta V. Radiation pneumonitis and pulmonary fibrosis in non-small-cell lung cancer: pulmonary function, prediction, and prevention. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):5-24. doi: 10.1016/j.ijrobp.2005.03.047.
- Background: PubMed 20171521Marks LB, Bentzen SM, Deasy JO, Kong FM, Bradley JD, Vogelius IS, El Naqa I, Hubbs JL, Lebesque JV, Timmerman RD, Martel MK, Jackson A. Radiation dose-volume effects in the lung. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S70-6. doi: 10.1016/j.ijrobp.2009.06.091.
- Background: PubMed 19380441Yuan X, Liao Z, Liu Z, Wang LE, Tucker SL, Mao L, Wang XS, Martel M, Komaki R, Cox JD, Milas L, Wei Q. Single nucleotide polymorphism at rs1982073:T869C of the TGFbeta 1 gene is associated with the risk of radiation pneumonitis in patients with non-small-cell lung cancer treated with definitive radiotherapy. J Clin Oncol. 2009 Jul 10;27(20):3370-8. doi: 10.1200/JCO.2008.20.6763. Epub 2009 Apr 20.
- Derived from this study: PubMed 31915028Tang Y, Yang L, Qin W, Yi MX, Liu B, Yuan X. Impact of genetic variant of HIPK2 on the risk of severe radiation pneumonitis in lung cancer patients treated with radiation therapy. Radiat Oncol. 2020 Jan 8;15(1):9. doi: 10.1186/s13014-019-1456-0.
- Derived from this study: PubMed 31540745Tang Y, Yang L, Qin W, Yi M, Liu B, Yuan X. Validation study of the association between genetic variant of IL4 and severe radiation pneumonitis in lung cancer patients treated with radiation therapy. Radiother Oncol. 2019 Dec;141:86-94. doi: 10.1016/j.radonc.2019.09.002. Epub 2019 Sep 17.
- Derived from this study: PubMed 26645682Tang Y, Liu B, Li J, Wu H, Yang J, Zhou X, Yi M, Li Q, Yu S, Yuan X. Genetic variants in PI3K/AKT pathway are associated with severe radiation pneumonitis in lung cancer patients treated with radiation therapy. Cancer Med. 2016 Jan;5(1):24-32. doi: 10.1002/cam4.564. Epub 2015 Dec 8.
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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, MD, PhD principal investigator
Tongji Hospital
1 site 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 1 site 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 7 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 1 site 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, MD, PhD (13667241722, yxl@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiation pneumonitis grade >=2 or 3 (time frame: 12 months after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02490319, which also lists 6 linked publications.
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 7 Oct 2022.