UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048941 |
|---|---|
| Receipt number | R000055722 |
| Scientific Title | Clinical study on long-term follow-up of patients treated with PDT |
| Date of disclosure of the study information | 2022/09/15 |
| Last modified on | 2022/09/15 10:33:41 |
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Basic information
Public title
Clinical study on long-term follow-up of patients treated with PDT
Acronym
Clinical study on long-term follow-up of patients treated with PDT
Scientific Title
Clinical study on long-term follow-up of patients treated with PDT
Scientific Title:Acronym
Clinical study on long-term follow-up of patients treated with PDT
Region
| Japan |
Condition
Condition
Oral squamous cell carcinoma
Oral epithelial dysplasia
Classification by specialty
| Surgery in general | Oral surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Long-term observation after PDT treatment for OSCC and ED (patients who have undergone PDT for more than 5 years) aims to clarify the recurrence rate, the presence or absence of neck lymph node metastasis, and the presence or absence of distant metastasis to other organs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment results (presence or absence of local recurrence, presence or absence of neck metastasis, presence or absence of distant metastasis) and prognosis (disease-specific survival rate, overall survival rate) in patients who have undergone PDT treatment for more than 5 years for OSCC and ED.
Key secondary outcomes
Base
Study type
Observational
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 who underwent PDT treatment for early OSCC and ED at Nagasaki University Hospital Oral Surgery between April 1, 2008 and December 31, 2013.
2. Patients with a pathological diagnosis of squamous cell carcinoma or epithelial dysplasia.
3.Patients who have continued regular checkups for more than 5 years after PDT treatment.
4. Any age
Key exclusion criteria
Cases undergoing PDT treatment for recurrent cases after surgical treatment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Narahara |
Organization
Nagasaki~University graduate school of Biomedical Medical
Division name
Regenerative oral surgery
Zip code
852-8102
Address
Nagasaki-shi sakamoto 1-7-1
TEL
095-819-7704
narashun@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shun |
| Middle name | |
| Last name | Narahara |
Organization
Nagasaki~University graduate school of Biomedical Medical
Division name
Regenerative oral surgery
Zip code
852-8102
Address
Nagasaki-shi sakamoto 1-7-1
TEL
095-819-7704
Homepage URL
narashun@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki-university hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki~University graduate school of Biomedical Medical Regenerative oral surgery
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
Nagasaki~University graduate school of Biomedical Medical Regenerative oral surgery
Address
Nagasaki-shi sakamoto 1-7-1
Tel
095-819-7704
narashun@nagasaki-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
| 2022 | Year | 09 | Month | 15 | 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
| 2022 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing special
Management information
Registered date
| 2022 | Year | 09 | Month | 15 | Day |
Last modified on
| 2022 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055722
