UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051986 |
|---|---|
| Receipt number | R000059326 |
| Scientific Title | Preliminary study on the usefulness of cancer risk assessment by saliva (SalivaChecker) |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/06/21 07:52:10 |
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Basic information
Public title
Preliminary study on the usefulness of cancer risk assessment by saliva (SalivaChecker)
Acronym
Preliminary study on the usefulness of cancer risk assessment by saliva (SalivaChecker)
Scientific Title
Preliminary study on the usefulness of cancer risk assessment by saliva (SalivaChecker)
Scientific Title:Acronym
Preliminary study on the usefulness of cancer risk assessment by saliva (SalivaChecker)
Region
| Japan |
Condition
Condition
Lung cancer, breast cancer, Colorectal cancer, stomach cancer, pancreatic cancer, and oral cancer
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Collect saliva samples from patients with lung cancer, breast cancer, colorectal cancer, stomach cancer, pancreatic cancer, and oral cancer and determined by Saliva Checker to calculate the sensitivity of this test method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk assessment of lung cancer, breast cancer, colorectal cancer, stomach cancer, pancreatic cancer, and oral cancer as determined by Saliva Checker
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients 18 years of age or older who have cancer of the lung, breast, colon, stomach, pancreas, or oral cavity and who visited a dentist for oral cavity management at Nagasaki University Hospital or Aichi-Gakuin University Hospital by February 28, 2024, from the date of approval by the hospital director (excluding overlapping cancer).
2.Patients who have given their consent to participate in this study.
Key exclusion criteria
1. Patients with severe xerostomia.
2. Pregnant or lactating patients.
3. Patients with severe cognitive impairment.
4. Other patients deemed inappropriate as research subjects by the investigator or others.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Soutome |
Organization
Nagasaki University
Division name
Preventive Dentistry
Zip code
8528588
Address
1-7-1, Sakamoto, Nagasaki
TEL
0958197663
sakiko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Soutome |
Organization
Nagasaki University
Division name
Preventive Dentistry
Zip code
8528588
Address
1-7-1, Sakamoto, Nagasaki
TEL
0958197663
Homepage URL
sakiko@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University and Aichi-Gakuin 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
Institution Review Bpard of Nagasaki University Hospital
Address
1-7-1, Sakamoto, Nagasaki
Tel
0958197229
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | 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
60
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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2003 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 09 | 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
none
Management information
Registered date
| 2023 | Year | 08 | Month | 23 | Day |
Last modified on
| 2024 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059326
