non-small-cell lung cancer combined with idiopathic pulmonary fibrosis
Conditions
Interventions
None listed
Sponsors
Jichi Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Cases with 20 years of age or over (2) Cases with c-stage I-IIIA non-small cell lung cancer diagnosed cytologically or histologically, or strongly suspected radiologically (3) Cases diagnosed as IPF on HRCT (possible UIP / definitive UIP under the 2011 International Guidelines) (4) Cases that are tolerable to general anesthesia (5) Cases with resectable lesions by lobectomy (6) Cases that satisfy the following criteria before registration. 1) Neutrophils: 1,500 / mm3 or more 2) Hemoglobin: not less than 10.0 g / dL 3) Platelets: 10.0 x 10^4 / mm3 or more 4) AST: 3 times or less of upper limit of facility reference value 5) ALT: 3 times or less of upper limit of facility reference value 6) Total bilirubin: 1.5 times or less of upper limit of the facility reference value 7) SpO 2 90% or more 8) Serum creatinine: 1.5 times or less of upper limit of facility reference value (7) Cases with postoperative predicted FEV1 is more than 1000 mL (8) Cases with good oral intake (9) Cases in which performance status (ECOG Scale) is 0 or 1 (10) Cases in which written consent has been obtained from the patient himself / herself after adequate explanation was made before study registration (11) Cases in the institutes other than Jichi Medical University. Samples will be collected and analyzed in Jichi Medical University.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To make biobanks of the immortalized lymphocytes for the future studies that investigate novel biomarkers for IPF and acute excerbation of IPF. | — |
Countries
Japan
Contacts
Public ContactOffice of North East Japan Study Group (NEJSG)
North East Japan Study Group Office
Outcome results
None listed