UMIN-CTR Clinical Trial

Basic information
Public title	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
Acronym	A study that investigates biomarkers for postoperative acute exacerbation of idiopathic pulmonary fibrosis, NEJ036B
Scientific Title	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
Scientific Title:Acronym	A study that investigates biomarkers for postoperative acute exacerbation of idiopathic pulmonary fibrosis, NEJ036B
Region	Japan

Condition
Condition	non-small-cell lung cancer combined with idiopathic pulmonary fibrosis
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The objective of this study is to investigate the predictive biomarkers associated with IPF and postoperative acute exacerbation in the patients with lung cancer and IPF. The biomarkers investigated using blood samples include lymphatic surface markers (CD62Llow CD4+, CD62Llow CD8+, CD25+Foxp3+ CD4+), telomere length, and genetic polymorphisms/mutaions (Telomerase, MUC5B, MUC4, SFTPC, SFTPA2, SFTPA1, ABCA3, TOLLIP) .
Basic objectives2	Others
Basic objectives -Others	The second objective is to establish biobanks of blood samples and DNA for future studies that investigate novel biomarkers.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	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.
Key secondary outcomes	To make biobanks of the immortalized lymphocytes for the future studies that investigate novel biomarkers for IPF and acute excerbation of IPF.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
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Interventions/Control_2
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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.
Target sample size	230

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koichi Hagiwara
Organization	Jichi Medical University
Division name	Division of Pulmonary Medicine, Department of Internal Medicine
Zip code
Address	3311-1 Shimotsuke-shi, Tochigi-ken 329-0498, Japan
TEL	+81-285-58-7349
Email	hagiwark@me.com

Public contact
Name of contact person	1st name Middle name Last name Office of North East Japan Study Group (NEJSG)
Organization	North East Japan Study Group
Division name	Office
Zip code
Address	302 Ogawa-building, 1-14-2 Taka hana-cho, Omiya-ku, Saitama-shi, Saitama 330-0803, Japan
TEL	+81-48-778-9521
Homepage URL
Email	nejsg-dm@nejsg.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	North East Japan Study Group
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 04 Month 02 Day
Date of IRB	2018 Year 04 Month 02 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2023 Year 12 Month 31 Day

Other

Other related information

The objective of this study is to investigate the predictive biomarkers associated with IPF and postoperative acute exacerbation in the patients with non-small-cell lung cancer and IPF. The biomarkers investigated using blood samples include lymphatic surface markers (CD62Llow CD4+, CD62Llow CD8+, CD25+Foxp3+ CD4+), telomere length, and genetic polymorphisms/mutaions (Telomerase, MUC5B, MUC4, SFTPC, SFTPA2, SFTPA1, ABCA3, TOLLIP) .

Management information
Registered date	2018 Year 04 Month 12 Day
Last modified on	2022 Year 04 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036729