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Trial record 1 of 1 for:    NCT02490319 | China
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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

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.

  1. Data including age, gender, smoking state, KPS, pulmonary function, disease history, histology, stage, surgery, chemotherapy, dosimetric parameters of radiotherapy were collected.
  2. Peripheral blood was collected from all patients enrolled.
  3. 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.

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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

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



Primary Outcome Measures :
  1. radiation pneumonitis grade >=2 or 3 [ Time Frame: 12 months after radiotherapy ]

Biospecimen Retention:   Samples With DNA
From peripheral blood


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:

  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

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