Study on the Biological Prediction Models of Radiation Pneumonitis
NCT ID: NCT02490319
Last Updated: 2022-10-07
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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UNKNOWN
300 participants
OBSERVATIONAL
2008-09-30
Brief Summary
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Detailed Description
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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.
2. Select candidate genes and pathways which may be associated with radiation pneumonitis and identify their tagSNPs by Haploview.
3. Use Kaplan-Meier and Cox model to analyze the association of all the factors collected with radiation pneumonitis.
4. Establish a biological prediction models for radiation pneumonitis based on the statistics analysis
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 radiation therapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Radiation dose at least 45 Gy
3. KPS\>60
4. Life expectancy of at least 6 months
5. Voluntarily signed the informed consent
Exclusion Criteria
2. Severe cardiopulmonary diseases
18 Years
80 Years
ALL
No
Sponsors
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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, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Locations
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Department of Oncology, Tongji Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Marks 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.
Yuan 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.
Tang 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.
Tang 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.
Tang 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.
Other Identifiers
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TJCC002
Identifier Type: -
Identifier Source: org_study_id
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