UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035607 |
|---|---|
| Receipt number | R000040556 |
| Scientific Title | Discovering immune complex antigen specific for oral cancer in saliva |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2021/06/14 10:04:59 |
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Basic information
Public title
Discovering immune complex antigen specific for oral cancer in saliva
Acronym
Immune complex antigens in oral cancer
Scientific Title
Discovering immune complex antigen specific for oral cancer in saliva
Scientific Title:Acronym
Immune complex antigens in oral cancer
Region
| Japan |
Condition
Condition
oral cancer
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aim to find immune complex antigens specifically found in saliva of the patients with oral cancer by immune complexome analysis where nano-liquid chromatography-tandem mass spectrometry is employed to comprehensively identify antigens incorporated into immunme complexes in biological fluids.
Basic objectives2
Others
Basic objectives -Others
Clinical Chemistry
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We analyze immune complex in saliva and identify antigen protein that is not recognized in patients with xerostomia and is specifically detected in oral cancer patients. In addition, we investigate whether specific ones of the antigen proteins are characteristic of patients who have cervical lymph node metastasis or distant metastasis.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. License date of the chief of the research institution - March 31, 2021, a hospital participating in Oral Surgery at Nagasaki University Hospital and Japan Oral Oncology Group (NPO) patient.
2. Target diseases: patients with oral cancer and patients with xerostomia (the standard of xerostomia is 2 g / 2 minutes or less in Saxon test saliva secretion)
3. Age: over 20 years old
4. Gender: male / female
5. Patient who obtained written agreement with the free will of the research subject himself after sufficient explanation for participation in this research.
Key exclusion criteria
1. Patients who are judged inappropriate as researchers by the researchers.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Kaname |
| Middle name | |
| Last name | Ohyama |
Organization
Nagasaki University
Division name
Graduate School of Biomedical Sciences
Zip code
852-8588
Address
Sakamoto 1-7-1, Nagasaki
TEL
095-819-8569
k-ohyama@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaname |
| Middle name | |
| Last name | Ohyama |
Organization
Nagasaki University
Division name
Graduate School of Biomedical Sciences
Zip code
852-8588
Address
Sakamoto 1-7-1, Nagasaki
TEL
095-819-8569
Homepage URL
k-ohyama@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Oral Oncology Group
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7200
gaibushikin@ml.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
長崎大学病院（長崎県）、日本口腔がん臨床研究グループ参加病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | 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 | 09 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 11 | 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
Presence of disease specific immune complex antigens
Management information
Registered date
| 2019 | Year | 01 | Month | 21 | Day |
Last modified on
| 2021 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040556
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| Registered date | File name |
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