A Study on Predictive Models and Clinical Outcome of Radi... | NCT05448703

Studies
A Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis

NCT05448703

Sponsor

Huazhong University of Science and Technology

Status

Recruiting

Last Update Posted

Oct 6, 2022Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Radiation Pneumonitis

Interventions

Blood Samples for Biomarkers

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 25, 2021Actual

Primary Completion Date

Sep 1, 2026Estimated

Completion Date

Sep 1, 2026Estimated

First Submitted Date

Jul 1, 2022

First Submission Date that Met QC Criteria

Jul 2, 2022

First Posted Date

Jul 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2022

Last Update Posted Date

Oct 6, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xianglin Yuan, Professor, Chief Physician, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Huazhong University of Science and TechnologyOTHER

Collaborators

Name	Class
Hubei Cancer Hospital	OTHER
Jingjiang People' Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Radiation pneumonitis is the main dose-limiting toxicity of thoracic radiotherapy, which can affect life quality, survival, and the tumor-controlling effects of patients receiving thoracic radiotherapy.

The purpose of this study is to:

Identify biomarkers including serum proteins, gene expression, genetic changes, and epigenetic modifications that determine radiation pneumonitis.
Investigate the relationship between radiation pneumonitis and other toxicities induced by radiotherapy.
Construct a predictive model for radiation pneumonitis.
Evaluate survival and treatment outcome of patients with radiation pneumonitis.

Detailed Description

Collect clinical information, CT images, and peripheral blood of the lung cancer patients treated with thoracic radiotherapy in Tongji Hospital, Hubei Cancer Hospital, and Jingjiang People's Hospital.
Follow up the enrolled patients. 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 CT, and information including survival status, symptoms, CT images, and treatment is collected. Radiation pneumonitis and other toxicities induced by radiotherapy are graded by two radiation oncologists according to the Common Terminology Criteria for Adverse Events 4.0 (CTCAE4.0).
Detect serum proteins, gene expression profile, single-nucleotide polymorphisms, and epigenetic modifications that may be associated with radiation pneumonitis.
Screen biomarkers that are associated with radiation pneumonitis via univariate and multivariate Cox regression analysis.
Construct a predictive model of radiation pneumonitis based on clinical information, radiomics, and biomarkers via machine learning or Least absolute shrinkage and selection operator.
Use Kaplan-Meier and Cox model to analyze the association of radiation pneumonitis with survival and efficacy of antitumor treatment.
Identify biomarkers and predictors of other toxicities induced by radiotherapy including radiation esophagitis, cardiotoxicity and radiodermatitis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Lung cancer patients treated with thoracic radiotherapy	Other: Blood Samples for Biomarkers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood Samples for Biomarkers	Other	blood sample to be taken at baseline, during radiotherapy, and after radiotherapy	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiation pneumonitis	radiation pneumonitis grade >=2 or 3 graded by CTCAE4.0. [Time Frame: 12 months after radiotherapy]	12 months after radiotherapy
Overall Survival	A long-term follow up will be scheduled to allow a complete survival analysis.	5 years after radiotherapy

Secondary Outcomes

Measure	Description	Time Frame
Other injuries induced by radiotherapy	Assessment of other common injuries induced by thoracic radiotherapy including injuries in heart, skin, and esophagus according to CTCAE4.0.	5 years after radiotherapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of lung cancer by histology
Radiation dose at least 45 Gy
Karnofsky >60
Age>18
Life expectancy of at least 6 months

Exclusion Criteria:

Previous thoracic irradiation
Severe cardiopulmonary diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Lung cancer patients treated with thoracic radiotherapy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xianglin Yuan, PhD	Contact	+8613667241722		yuanxianglin@hust.edu.cn
Lingyan Xiao, MD	Contact	+8615971474885		lingyan.xiao123@gmail.com

Overall Officials

Name	Affiliation	Role
Xianglin Yuan, PhD	Tongji Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology	Recruiting	Wuhan	Hubei	43000	China

Condition Browse Module

MeSH Terms

ID	Term
D017564	Radiation Pneumonitis

Ancestor Terms

ID	Term
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D055370	Lung Injury

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection
D015415	Biomarkers

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided