Study on the Biological Prediction Models of Radiation Pneumonitis

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.

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Xianglin Yuan, MD, PhD; Phone Number: 13667241722; Email: yxl@medmail.com.cn
• Study Contact Backup: Name: Yang Tang, MD, PhD; Phone Number: 18627182062; Email: tangyangtjmu@126.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
radiation pneumonitis grade >=2 or 3	12 months after radiotherapy

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Principal Investigator: Xianglin Yuan, MD, PhD, Tongji Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: lung cancer; radiation pneumonitis; genetic variants; prediction models
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Lung Diseases, Interstitial; Lung Injury; Radiation Injuries; Pneumonia; Radiation Pneumonitis
• Other Study ID Numbers: TJCC002