UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051200 |
|---|---|
| Receipt number | R000058392 |
| Scientific Title | Clinical Research on Sirolimus Data Repository |
| Date of disclosure of the study information | 2023/05/31 |
| Last modified on | 2023/10/10 16:46:38 |
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Basic information
Public title
Clinical Research on Sirolimus Data Repository
Acronym
Clinical Research on Sirolimus Data Repository
Scientific Title
Clinical Research on Sirolimus Data Repository
Scientific Title:Acronym
Clinical Research on Sirolimus Data Repository
Region
| Japan |
Condition
Condition
Lymphangioleiomyomatosis, Refractory Lymphatic Disorders
Classification by specialty
| Medicine in general | Pneumology | Pediatrics |
| Plastic surgery | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have constructed a consolidated dataset (data repository) of the clinical trial data on sirolimus that has been conducted to date by the Jasmine Association (Sirolimus New Mechanism Research Group). The purpose is to utilize the aggregated data for further multifaceted examinations, with the aim of safely and appropriately administering it to patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will conduct a cross-sectional analysis and examination of the collected trial data in terms of safety (compiling adverse events) and pharmacokinetic information (PK parameters)."
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 1 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients and healthy adults who participated in past studies using Sirolimus (the following 4 trials):
A multi-institutional clinical trial on the safety of Sirolimus administration for lymphangioleiomyomatosis (MLSTS Trial) / Niigata University Medical and Dental Hospital
A multi-institutional, Phase III, investigator-initiated clinical trial to study the efficacy and safety of NPC-12T (Sirolimus) for refractory lymphatic disorders (NPC-12T-LM Trial) / Gifu University Hospital
A multi-institutional, Phase III, investigator-initiated clinical trial to study the efficacy and safety of NPC-12T (granules/tablets) for refractory vascular tumors and vascular malformations (NPC-12T-CVA Trial) / Gifu University Hospital
A multi-institutional, open-label, non-controlled trial to study the safety and efficacy of Sirolimus for refractory vascular and lymphatic disorders (SRL-ACV-01 Trial) / Gifu University Hospital
Key exclusion criteria
Declined to participate in the research
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Toshinori |
| Middle name | |
| Last name | Takada |
Organization
Niigata University Medical and Dental Hospital
Division name
Uonuma Institute of Community Medicine
Zip code
9518510
Address
757 Asahimachi-dori 1-bancho, Chuo-ku, Niigata-shi, Niigata 951-8520, Japan , Niigata University Medical and Dental Hospita
TEL
025-227-2191
ttakada@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Tanaka |
Organization
Niigata University Medical and Dental Hospital
Division name
Clinical and Translational Research Center
Zip code
951-8514
Address
5274 Gakkocho-dori 2-bancho, Chuo-ku, Niigata-shi, Niigata 951-8514
TEL
025-368-9337
Homepage URL
ta-tnk@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Jasmine Association (Sirolimus New Mechanism Research Group)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University
Address
754 Asahimachi-dori 1-bancho, Chuo-ku, Niigata-shi, Niigata 951-8510
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 | 05 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exam Registration Data Now Available
Management information
Registered date
| 2023 | Year | 05 | Month | 30 | Day |
Last modified on
| 2023 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058392
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/05/30 | 20230524_確定_倫理_研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/05/31 | 【シロリムス】共通DB定義_20220728.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/07/05 | 【シロリムス】共通DB_20220729.zip |
Single case data URL
Value
https://center6.umin.ac.jp/ice/58392
