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A research that investigates biomarkers for postoperative acute exacerbation of idiopathic pulmonary fibrosis (IPF) in the patients with non-small-cell lung cancer and IPF, NEJ036B

Not Applicable
Conditions
non-small-cell lung cancer combined with idiopathic pulmonary fibrosis
Registration Number
JPRN-UMIN000032212
Lead Sponsor
Jichi Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
230
Inclusion Criteria

Not provided

Exclusion Criteria

(1) Patients with past thoracotomy or thoracoscopic surgery (the cases with surgical biopsy for IPF diagnostic purposes or the cases after 6 months or more since biopsy were excluded) (2) Cases with prior therapies for IPF (pirfenidone, nintedanib, immunosuppressive drugs, etc.) (3) Cases in which corticosteroids, macrolide antibiotics or both are currently administered (4) Cases with a history of chemotherapy and/or radiotherapy in which the lung enters the irradiation field (5) Cases in which the cause of interstitial pneumonia is revealed, such as drug properties, environmental exposure, collagen disease, etc. (6) Cases receiving oxygen therapy (7) Cases with local or systemic active infections requiring treatment (8) Cases with severe complications such as poor control heart disease, glaucoma, diabetes, gastrointestinal bleeding, etc. (9) Cases with a history of severe hypersensitivity (10) Cases those are considered difficult to register due to mental illness (11) Pregnant women, lactating women, women who are currently pregnant, or women who are not willing to contraceptive (12) Cases with a history of obvious IPF acute exacerbation in the past (13) Other cases judged inappropriate by the attending doctors.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The predictive value of lymphatic surface markers (CD62Llow CD4+, CD62Llow CD8+, CD25+Foxp3+ CD4+), telomere length, and genetic polymorphisms/mutaions (Telomerase, MUC5B, MUC4, SFTPC, SFTPA2, SFTPA1, ABCA3, TOLLIP) for IPF and postoperative acute excerbation.
Secondary Outcome Measures
NameTimeMethod
To make biobanks of the immortalized lymphocytes for the future studies that investigate novel biomarkers for IPF and acute excerbation of IPF.
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