UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047168 |
|---|---|
| Receipt number | R000053802 |
| Scientific Title | Isolation of Porphyromonas gingivalis from oral cavity and microbiological and immunological profiling of saliva in cancer patients |
| Date of disclosure of the study information | 2022/03/14 |
| Last modified on | 2024/09/18 19:20:01 |
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Basic information
Public title
Isolation of Porphyromonas gingivalis from oral cavity and microbiological and immunological profiling of saliva in cancer patients
Acronym
Cancer and oral bacteria
Scientific Title
Isolation of Porphyromonas gingivalis from oral cavity and microbiological and immunological profiling of saliva in cancer patients
Scientific Title:Acronym
Cancer and oral bacteria
Region
| Japan |
Condition
Condition
Cancer and periodontal disease
Classification by specialty
| Medicine in general | Surgery in general | Oral surgery |
| Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate relationship between cancer and periodontal disease
Basic objectives2
Others
Basic objectives -Others
Isolation of P. gingivalis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Metagenome analsis in saliva and isolation of a number of P. gingivalis
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age between 30 and 80 years
2. Cancer patients with the following cancers who visit the dental department of the National Cancer Center Hostpital, and
I. Oral and pharyngeal cancer (limited to squamous cell carcinoma)
II. Breast cancer (limited to adenocarcinoma)
III. Pancreatic cancer (limited to adenocarcinoma)
IV. Colon cancer (adenocarcinoma only)
Or subjects who do not have any history of cancer and currently visiting Fujimidai Dental Clinic
(V) Non-cancer subjects
3. Performance Status (PS, Eastern Cooperative Oncology Group, ECOG): 0-2
4. With teeth with moderate to severe chronic periodontitis (periodontal pockets, not less than 5 mm).
5. Written consent has been obtained from the individual.
Key exclusion criteria
(1) Those that have not received any antimicrobials or anticancer drugs in the past three months.
(2) No history of allergies (both food and drugs).
(3) Not currently smoking.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryoma |
| Middle name | |
| Last name | Nakao |
Organization
National Institute of Infectious Diseases
Division name
Department of Bacteriology I
Zip code
162-8640
Address
1-23-1, Toyama, Shinjuku-ku, Tokyo
TEL
03-5285-1111
ryoma73@niid.go.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | nakao |
Organization
National Institute of Infectious Diseases
Division name
Department of Bacteriology I
Zip code
162-8640
Address
1-23-1, Toyama, Shinjuku-ku, Tokyo
TEL
03-5285-11111
Homepage URL
ryoma73@niid.go.jp
Sponsor or person
Institute
National Institute of Infectious Diseases
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Dentistry, National Cancer Center Hospital
Name of secondary funder(s)
Fujimidai Dental Clinic
IRB Contact (For public release)
Organization
National Institute of Infectious Diseases
Address
1-23-1, Toyama, Shinjuku-ku, Tokyo
Tel
03-5285-1111
ryoma73@niid.go.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
国立がん研究センター中央病院(東京都)、富士見台歯科医院(千葉県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 14 | 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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 14 | 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 to specially mention
Management information
Registered date
| 2022 | Year | 03 | Month | 14 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053802
