Unique ID issued by UMIN | UMIN000032212 |
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Receipt number | R000036729 |
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 |
Date of disclosure of the study information | 2018/05/01 |
Last modified on | 2022/04/15 15:04:08 |
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
A study that investigates biomarkers for postoperative acute exacerbation of idiopathic pulmonary fibrosis, NEJ036B
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
A study that investigates biomarkers for postoperative acute exacerbation of idiopathic pulmonary fibrosis, NEJ036B
Japan |
non-small-cell lung cancer combined with idiopathic pulmonary fibrosis
Pneumology | Chest surgery |
Malignancy
YES
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) .
Others
The second objective is to establish biobanks of blood samples and DNA for future studies that investigate novel biomarkers.
Exploratory
Explanatory
Not applicable
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.
To make biobanks of the immortalized lymphocytes for the future studies that investigate novel biomarkers for IPF and acute excerbation of IPF.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
(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.
(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.
230
1st name | |
Middle name | |
Last name | Koichi Hagiwara |
Jichi Medical University
Division of Pulmonary Medicine, Department of Internal Medicine
3311-1 Shimotsuke-shi, Tochigi-ken 329-0498, Japan
+81-285-58-7349
hagiwark@me.com
1st name | |
Middle name | |
Last name | Office of North East Japan Study Group (NEJSG) |
North East Japan Study Group
Office
302 Ogawa-building, 1-14-2 Taka hana-cho, Omiya-ku, Saitama-shi, Saitama 330-0803, Japan
+81-48-778-9521
nejsg-dm@nejsg.jp
Jichi Medical University
North East Japan Study Group
Non profit foundation
NO
2018 | Year | 05 | Month | 01 | Day |
Unpublished
Terminated
2018 | Year | 04 | Month | 02 | Day |
2018 | Year | 04 | Month | 02 | Day |
2018 | Year | 06 | Month | 01 | Day |
2020 | Year | 12 | Month | 31 | Day |
2023 | Year | 12 | Month | 31 | Day |
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) .
2018 | Year | 04 | Month | 12 | Day |
2022 | Year | 04 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036729
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