UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044334 |
|---|---|
| Receipt number | R000050634 |
| Scientific Title | Research using samples and information in bone and soft tissue sarcoma resection at Gunma University Hospital Orthopedic Surgery |
| Date of disclosure of the study information | 2021/05/26 |
| Last modified on | 2021/05/26 12:30:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research using samples and information in bone and soft tissue sarcoma resection at Gunma University Hospital Orthopedic Surgery
Acronym
Research using samples and information in bone and soft tissue sarcoma resection at Gunma University Hospital Orthopedic Surgery
Scientific Title
Research using samples and information in bone and soft tissue sarcoma resection at Gunma University Hospital Orthopedic Surgery
Scientific Title:Acronym
Research using samples and information in bone and soft tissue sarcoma resection at Gunma University Hospital Orthopedic Surgery
Region
| Japan |
Condition
Condition
Bone and soft tissue sarcoma
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to perform photoimmunotherapy (PIT) on tumor tissues and tumor cells resected during surgery in patients with bone and soft tissue sarcoma and to verify the therapeutic effect of PIT on bone and soft tissue sarcoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of photoimmunotherapy (PIT) on the tumor tissue resected when the primary bone and soft tissue tumor was resected will be examined. Regarding the effect of PIT, the number of surviving tumor cells after photoimmunotherapy and the size of transplanted tumor tissue are statistically analyzed.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with primary bone and soft tissue tumor
2) Patients who will undergo tumor resection (including biopsy) at our hospital
Key exclusion criteria
1) Patients for whom consent was not obtained
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Okamura |
Organization
Gunma Univesrsity
Division name
Orthopaedic Surgery
Zip code
3718511
Address
3-39-22 Showamachi, Maebashi, Gunma
TEL
0272208269
kokamura@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Office |
| Middle name | |
| Last name | Office |
Organization
Gunma Univesrsity
Division name
IRB
Zip code
3718511
Address
3-39-15 Showamachi, Maebashi, Gunma
TEL
0272208740
Homepage URL
ciru_hitotaisho-irb@ml.gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
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
Gunma University
Address
3-39-15 Showamachi, Maebashi, Gunma
Tel
0272208740
ciru_hitotaisho-irb@ml.gunma-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
| 2021 | Year | 05 | Month | 26 | 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
| 2020 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Tumor cells collected at the time of surgery are cultured, and the effect of photoimmunotherapy is confirmed on the cultured cells by animal experiments using in vitro and mice.
Management information
Registered date
| 2021 | Year | 05 | Month | 26 | Day |
Last modified on
| 2021 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050634
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
