Clinical trial NCT02490319: Study on the Biological Prediction Models of Radiation Pneumonitis
Official title: Study on the Biological Prediction Models of Radiation Pneumonitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radiation Pneumonitis
Keywords: radiation pneumonitis
lung cancer
prediction models
genetic variants
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2015-07-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of lung cancer by histology
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:

1. Previous thoracic irradiation
2. Severe cardiopulmonary diseases

Primary outcomes:
measure: radiation pneumonitis grade >=2 or 3
timeFrame: 12 months after radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Oncology, Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Xianglin Yuan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.