UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041659 |
|---|---|
| Receipt number | 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 06:57:43 |
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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
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
hkosuke@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047512
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
