NCT02490319

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

14.8 years

First QC Date

July 1, 2015

Last Update Submit

October 5, 2022

Conditions

Radiation Pneumonitis

Keywords

radiation pneumonitislung cancerprediction modelsgenetic variants

Outcome Measures

Primary Outcomes (1)

  • radiation pneumonitis grade >=2 or 3

    12 months after radiotherapy

Study Arms (1)

Group 1

Lung cancer patients treated with thoracic radiation therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Previous thoracic irradiation
  • Severe cardiopulmonary diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 15963660BACKGROUND

  • 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.

    PMID: 20171521BACKGROUND

  • 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.

    PMID: 19380441BACKGROUND

  • 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.

    PMID: 31915028DERIVED

  • 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.

    PMID: 31540745DERIVED

  • 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.

    PMID: 26645682DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

From peripheral blood

MeSH Terms

Conditions

Radiation PneumonitisLung Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesLung InjuryRadiation InjuriesWounds and InjuriesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Xianglin Yuan, MD, PhD

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianglin Yuan, MD, PhD

CONTACT

13667241722yxl@medmail.com.cn

Yang Tang, MD, PhD

CONTACT

18627182062tangyangtjmu@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Chief Physician

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 3, 2015

Study Start

September 1, 2008

Primary Completion

July 1, 2023

Last Updated

October 7, 2022

Record last verified: 2022-10

Locations

CN(1)