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Study on the Biological Prediction Models of Radiation Pneumonitis

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ClinicalTrials.gov Identifier: NCT02490319

Recruitment Status : Unknown

Verified July 2015 by Xianglin Yuan, Huazhong University of Science and Technology.
Recruitment status was: Recruiting

First Posted : July 3, 2015

Last Update Posted : July 10, 2015

Sponsor:

Information provided by (Responsible Party):

Xianglin Yuan, Huazhong University of Science and Technology

Study Description

Brief 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. 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.

Condition or disease
Radiation Pneumonitis

Detailed Description:

1. 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.

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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	300 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Study on the Biological Prediction Models of Radiation Pneumonitis
Study Start Date :	September 2008
Estimated Primary Completion Date :	July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Group 1 Lung cancer patients treated with thoracic radiation therapy

Outcome Measures

Primary Outcome Measures :

radiation pneumonitis grade >=2 or 3 [ Time Frame: 12 months after radiotherapy ]

Biospecimen Retention: Samples With DNA

From peripheral blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Lung cancer patients treated with radiation therapy at Tongji Hospital, Huazhong University of Science and Technology (Wuhan, Hubei Province, China).

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Previous thoracic irradiation
Severe cardiopulmonary diseases

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490319

Contacts

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Contact: Xianglin Yuan, MD, PhD	13667241722	yxl@medmail.com.cn
Contact: Yang Tang, MD, PhD	18627182062	tangyangtjmu@126.com

Locations

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China, Hubei
Department of Oncology, Tongji Hospital	Recruiting
Wuhan, Hubei, China, 430030
Contact: Xianglin Yuan, MD, PhD 13667241722 yxl@medmail.com.cn
Contact: Yang Tang, MD, PhD 18627182062 tangyangtjmu@126.com
Principal Investigator: Xianglin Yuan, MD, PhD
Sub-Investigator: Yang Tang, MD, PhD

Sponsors and Collaborators

Huazhong University of Science and Technology

Investigators

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Principal Investigator:	Xianglin Yuan, MD, PhD	Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

More Information

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. Review.

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. Review.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Xianglin Yuan, Professor, Chief Physician, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:	NCT02490319
Other Study ID Numbers:	TJCC002
First Posted:	July 3, 2015 Key Record Dates
Last Update Posted:	July 10, 2015
Last Verified:	July 2015

Keywords provided by Xianglin Yuan, Huazhong University of Science and Technology:


radiation pneumonitis lung cancer prediction models genetic variants

Additional relevant MeSH terms:

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Pneumonia Radiation Pneumonitis Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections	Lung Diseases, Interstitial Lung Injury Radiation Injuries Wounds and Injuries

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