UMIN-CTR Clinical Trial

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
Email	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
Email	narashun@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki-university hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055722