UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031742 |
|---|---|
| Receipt number | R000034934 |
| Scientific Title | Efficacy of systemic venous sampling of FGF23 to localize responsible tumors in tumor-induced rickets/osteomalacia |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2024/03/19 09:15:05 |
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Basic information
Public title
Efficacy of systemic venous sampling of FGF23 to localize responsible tumors in tumor-induced rickets/osteomalacia
Acronym
Efficacy of systemic venous sampling of FGF23
Scientific Title
Efficacy of systemic venous sampling of FGF23 to localize responsible tumors in tumor-induced rickets/osteomalacia
Scientific Title:Acronym
Efficacy of systemic venous sampling of FGF23
Region
| Japan |
Condition
Condition
Tumor-induced rickets/osteomalacia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze whether a combination of systemic venous sampling of FGF23 and imaging studies, such as FDG-PET/CT and octreoscan, shows higher sensitivity and positive predictive value compared to imaging studies alone to localize responsible tumors in TIO.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether a combination of systemic venous sampling of FGF23 and imaging studies, such as FDG-PET/CT and octreoscan, shows higher sensitivity and positive predictive value compared to imaging studies alone to localize responsible tumors in TIO.
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
Perform octreoscan and FDG-PET/CT in patients with probable TIO. Perform systemic venous sampling of FGF23 in those with no accumulation on these imaging studies or those with tumors that need more conclusive localization before high-risk surgery.Collect 22 blood samples from major veins of the patients using catheter that inserted in the femoral vein.Measure serum FGF23 value in each sample using human FGF23 ELISA kit. The region where serum FGF23 value is 1.3 times higher than that of the minimum value is considered as a candidate.If the localization of the tumor is clarified by these studies, either biopsy or surgical removal of the tumor is performed. Immunohistochemical staining for FGF23 is performed on tissue samples.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with probable TIO according to the diagnostic test for osteomalacia. Patients who are given sufficient explanation of the study and submit informed consent with a thorough understanding of the study.
Key exclusion criteria
Patients with serious kidney disease(eGFR<30 mL/min/1.73m2). Patients who are pregnant. Patients who are considered ineligible for the study by investigators' decision.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Ito |
Organization
The University of Tokyo Hospital
Division name
The division of Nephrology and Endocrinology
Zip code
1138655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
0338155411
nobito-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Nobuaki |
| Middle name | |
| Last name | Ito |
Organization
The University of Tokyo Hospital
Division name
The division of Nephrology and Endocrinology
Zip code
1138655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
0338155411
Homepage URL
nobito-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Office for Human Research Studies, Graduate School of Medicine and Faculty of Medicine
Address
7-3-1 Hongo Bunkyo-ku Tokyo JAPAN
Tel
03-5841-3600
ethics@m.u-tokyo.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
| 2018 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034934
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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