UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050816 |
|---|---|
| Receipt number | R000057895 |
| Scientific Title | Perioperative change in serum markers of oxidative stress in lung cancer patients with interstitial lung disease undergoing surgical resection. |
| Date of disclosure of the study information | 2023/04/11 |
| Last modified on | 2024/04/11 17:51:18 |
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Basic information
Public title
Can perioperative change in serum markers of oxidative stress predict acute exacerbation of interstitial lung disease in lung cancer patients undergoing surgical resection?
Acronym
Can markers of oxidative stress predict postoperative acute exacerbation of interstitial lung disease?
Scientific Title
Perioperative change in serum markers of oxidative stress in lung cancer patients with interstitial lung disease undergoing surgical resection.
Scientific Title:Acronym
Perioperative change in oxidative stress in patients with interstitial lung disease undergoing surgical resection.
Region
| Japan |
Condition
Condition
Lung cancer patients with interstitial lung disease undergoing surgical resection
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the predictive effect of perioperative change in serum markers of oxidative stress on postoperative acute exacerbation of interstitial lung disease in lung cancer patients undergoing surgical resection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between perioperative change in serum levels of Diacron-reactive oxygen metabolites and Biological antioxidant potential, and the incidence of postoperative acute exacerbation of interstitial lung disease
Key secondary outcomes
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
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Primary lung cancer or Suspicion of primary lung cancer
2. 18 y.o. or older
3. ECOG performance status:0-1
4. No previous history of lung resection
5: Radiological usual interstitial pneumonia (UIP) pattern and possible UIP pattern on an Official ATS/ERS/JRS/ALAT Clinical Practice Guideline
6. Written informed consent is obtained
Key exclusion criteria
1. Inconsistent with UIP pattern on an Official ATS/ERS/JRS/ALAT Clinical Practice Guideline
2. Considered inappropriate by attending physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Terumoto |
| Middle name | |
| Last name | Koike |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Thoracic and Cardiovascular Surgery
Zip code
951-8520
Address
1-757 Asahimachi-dori, Chuo-ku Niigata, Niigata, Japan
TEL
025-227-2243
t-koike@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Terumoto |
| Middle name | |
| Last name | Koike |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Thoracic and Cardiovascular Surgery
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku Niigata, Niigata, Japan
TEL
025-227-2243
Homepage URL
t-koike@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Niigata University
Address
1-757 Asahimachi-dori, Chuo-ku Niigata, Niigata, Japan
Tel
025-227-2625
ethics@adm.niigata-u.ac.jp
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
| 2023 | Year | 04 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Single-institutional, prospective, and observational study
Sample Size: 60 patients
Enrollment period: 3 years
Primary endpoint: Levels of serum d-ROM and BAP at preoperative, immediately after surgery, postoperative day 1, 3, 6, and postoperative 1 month, and their changes.
Secondary endpoints:
1. Average value and 95% CI of serum d-ROM and BAP levels at each time point.
2. Analyzing risk factors for postoperative acute exacerbation of interstitial lung disease.
3. Quantitative and expression analyses of HIF-1 alpha in the lung tissue samples from the couples of patients who developed and did not develop postoperative acute exacerbation of interstitial lung disease.
Management information
Registered date
| 2023 | Year | 04 | Month | 11 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057895
| Research Plan | |
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| Registered date | File name |
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