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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041659
Receipt No. R000047512
Scientific Title The significance of changes in tumor hypoxia by anti-PD-1 / PD-L1 antibody therapy for advanced non-small cell lung cancer.
Date of disclosure of the study information 2020/09/03
Last modified on 2020/09/01

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Basic information
Public title The significance of changes in tumor hypoxia by anti-PD-1 / PD-L1 antibody therapy for advanced non-small cell lung cancer.
Acronym Hypoxia and immunotherapy in lung cancer
Scientific Title The significance of changes in tumor hypoxia by anti-PD-1 / PD-L1 antibody therapy for advanced non-small cell lung cancer.
Scientific Title:Acronym Hypoxia and immunotherapy in lung cancer
Region
Japan

Condition
Condition advanced non-small cell lung cancer
Classification by specialty
Pneumology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Changes in FMISO uptake on PET before and after PD-1 blockade treatment
Basic objectives2 Others
Basic objectives -Others none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of SUVmax, MTV and TLG of FMISO accumulation on PET
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 We perform FMISO-PET before and 8 weeks after immune checkpoint inhibitor treatment
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients diagnosed with advanced non-small cell lung cancer
2. Patients who are scheduled to be treated with immune checkpoint inhibitors (anti-PD-1/PD-L1 antibodies)
3. Patients over the age of 20 when consent is obtained
4.Patients undergoing FDG-PET for whole body search
5. Patients with measurable lesions
6. Patients who have major organ functions
7. Patients who have obtained informed consent for this study
Key exclusion criteria 1. Pregnant women, lactating women and women with the possibility or intention of becoming pregnant
2. Patients with complications that require intravenous administration of antibiotics and antifungal agents
3.Patients who need to administer systemic steroids and other immunosuppressive drugs
4. Patients with diabetes
5. In addition, patients who are judged as inappropriate by the doctor's judgment
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kosuke
Middle name
Last name Hashimoto
Organization Saitama Medical University International Medical Center
Division name Respiratory medicine
Zip code 350-1298
Address 1397-1 Yamane, Hidaka City, Saitama Prefecture
TEL 042-984-4177
Email hkosuke@saitama-med.ac.jp

Public contact
Name of contact person
1st name Kosuke
Middle name
Last name Hashimoto
Organization Saitama Medical University International Medical Center
Division name Respiratory medicine
Zip code 350-1298
Address 1397-1 Yamane, Hidaka City, Saitama Prefecture
TEL 042-984-4177
Homepage URL
Email hkosuke@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Saitama Medical University International Medical Center
Address 1397-1 Yamane, Hidaka City, Saitama Prefecture
Tel 042-984-4177
Email hkosuke@saitama-med.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 埼玉医科大学国際医療センター

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 03 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
2020 Year 06 Month 25 Day
Date of IRB
2020 Year 08 Month 05 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2023 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 02 Day
Last modified on
2020 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047512

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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