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Establishment of an Early Warning and Prevention System for Drug- and Radiation-Induced Lung Injury Based on Blood Omics

Establishment of an Early Warning and Prevention System for Drug- and Radiation-Induced Lung Injury Based on Blood Omics

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126982
Enrollment
Unknown
Registered
2026-06-22
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-Induced Lung Injury, Radiation-Induced Lung Injury

Interventions

atients were divided into those with and without lung injury (DLI, drug-induced lung injury
RILI, radiation-induced lung injury) during follow-up for between-group comparison.:None

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.The age range is 18–75 years, with an ECOG PS score of 0–2. 2.Intended to initiate treatment with a high risk of lung injury, including: (1) High-risk medications (specific immune checkpoint inhibitors, molecular targeted drugs, chemotherapeutic agents, antibiotics, or cardiovascular drugs, etc.); (2) Thoracic radiotherapy (with radiation target volumes involving lung tissue). 3.Expected survival =6 months, with complete baseline clinical assessment data (including HRCT imaging, pulmonary function tests, and laboratory examinations, etc.); 4.The functions of the major organs are generally normal, meeting the routine indications for treatment. 5.Sign the informed consent form for participation in this clinical trial.

Exclusion criteria

Exclusion criteria: 1.Previously diagnosed with severe interstitial lung disease, pulmonary fibrosis, or currently in the active phase of a severe pulmonary infection. 2.Patients who have had a severe active pulmonary infection within the 4 weeks prior to enrollment and whose imaging findings have not yet fully resolved. 3.Patients who have previously received thoracic radiotherapy. 4.Patients with severe coagulation disorders or other conditions that make it unsuitable or who refuse to undergo the collection of biological specimens such as blood and sputum. 5.Patients who have severe claustrophobia or physical limitations (e.g., inability to lie flat) that objectively prevent them from cooperating in completing a high-resolution computed tomography (HRCT) examination. 6.Patients with other malignant tumors that are not effectively controlled, apart from the primary disease. 7.Female patients who are pregnant or breastfeeding. 8.According to the investigator’s judgment, there are concomitant diseases that seriously endanger the safety of the subject, may confound the study results, or affect the subject’s ability to complete this study.

Design outcomes

Primary

MeasureTime frame
Area under the (ROC) curve, Sensitivity, Specificity;Calibration;Decision Curve Analysis;

Secondary

MeasureTime frame
Clinical symptoms;Imaging parameters;Pulmonary function parameters;

Countries

China

Contacts

Public ContactBingwen Zou

West China Hospital of Sichuan University

zoubingwen81@163.com+86 28 85421479

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026