Tokyo, Feb. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060497) titled 'A Real-world Survey on Treatment and Prognosis Following Primary Lung Cancer Development in Patients with Interstitial Lung Disease Undergoing Antifibrotic Therapy: A Multicenter Retrospective Study' on Feb. 2.
Study Type:
Observational
Primary Sponsor:
Institute - Labour and Welfare Research Group on Diffuse Lung Diseases in Ministry of Health
Condition:
Condition - Primary lung cancer with interstitial lung disease
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To elucidate the therapeutic interventions and prognostic outcomes in patients with primary lung cancer who also have interstitial lung disease while undergoing antifibrotic drug therapy.
Basic objectives2 - Bio-equivalence
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Age: 20 years or older
2. Patients diagnosed with any interstitial lung disease
3. Patients who have been on antifibrotic therapy for 3 months or longer
4. Patients diagnosed with primary lung cancer while receiving antifibrotic therapy
Key exclusion criteria - 1. Patients not receiving antifibrotic drugs for ILD
2. Patients with interstitial changes of 10% or less on chest HRCT (ILA patients)
3. Patients in which anti-fibrotic drugs for ILD were discontinued, followed by the development of primary lung cancer
4. Patients in which anti-fibrotic drugs were initiated after diagnosis of primary lung cancer
5. Patients in which anticancer drugs were administered for primary lung cancer prior to anti-fibrotic drug administration
6. Drug-induced ILD
7. Patients deemed unsuitable as study subjects by the principal investigator
Target Size - 500
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 15 Day
Anticipated trial start date - 2026 Year 01 Month 01 Day
Last follow-up date - 2026 Year 04 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067458
Disclaimer: Curated by HT Syndication.
