UMIN-ICDS Clinical Trial

Public title

Elucidation of new molecular mechanism of pancreatic cancer development by subgingival plaque microbiome analysis

Acronym

Elucidation of new molecular mechanism of pancreatic cancer development by subgingival plaque microbiome analysis

Scientific Title

Elucidation of new molecular mechanism of pancreatic cancer development by subgingival plaque microbiome analysis

Scientific Title:Acronym

Pancreatic cancer and subgingival plaque bacterial flora

Region

Japan

Condition

pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To clarify the relationship between pancreatic carcinogenesis and subgingival plaque bacterial flora.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Composition of bacterial flora

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Be at least 18 years old at the time of consent.
2) Written consent has been obtained from the individual to participate in the study.
3) (Pancreatic tumor group) A pathological diagnosis of pancreatic cancer (including class IV by cytology) has been obtained.
4) (Disease control group) A pathological diagnosis of cancer of the esophagus, stomach, or colon has been obtained, treatment under general anesthesia is planned, and abdominal MRI or abdominal contrast-enhanced CT has been performed.
5) (Control group) Patients were scheduled for treatment under general anesthesia for a benign disease and underwent abdominal MRI or contrast-enhanced CT.

Key exclusion criteria

1) All molars are missing
2) (Pancreatic tumor group) Patients with malignant tumors other than the pancreas.
3) (Disease control group) (Control group) Has a history of pancreatic resection.
4) (Disease control group) (Control group) Abdominal MRI or abdominal contrast-enhanced CT indicates pancreatic tumor, chronic pancreatitis, or pancreatic cystic lesion.

Target sample size

90

Name of lead principal investigator

1st name	Nobuhiko
Middle name
Last name	Fukuba

Organization

Shimane University

Division name

Internal medicine II

Zip code

6938501

Address

89-1,Enya-cho, Izumo, Shimane,Japan

TEL

0853202111

Email

nfukuba@med.shimane-u.ac.jp

Name of contact person

1st name	Nobuhiko
Middle name
Last name	Fukuba

Organization

Shimane University

Division name

Internal medicine II

Zip code

6938501

Address

89-1,Enya-cho, Izumo, Shimane,Japan

TEL

0853202111

Homepage URL

Email

fnat98@yahoo.co.jp

Institute

Shimane University

Institute

Department

Personal name

Organization

No

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Research Ethics Committee,Shimane University Faculty of Medicine

Address

89-1,Enya-cho, Izumo, Shimane,Japan

Tel

0853-20-2515

Email

kenkyu@med.shimane-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

11

Month

08

Day

Date of IRB

Anticipated trial start date

2023

Year

11

Month

09

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1. Questions to ask during registration (questionnaire format)
1) Age
2) Gender
3) Smoking history
4) Drinking history
5) Underlying disease
6) Family history of pancreatic cancer
7) Disease being treated
2. Inspection/observation items at the time of registration
1) Subgingival plaque collection site
2) Degree of periodontal disease (Periodontal Inflamed Surface Area [PISA])
3) Subgingival plaque bacterial flora analysis
4) Salivary bacterial flora analysis
5) Fecal microbiota analysis
6) (Pancreatic tumor group) Final pathological diagnosis (histological type, site (head, body, tail), maximum diameter (mm), TNM classification (UICC-8 version))
7) (Disease control group) (Control group) Purpose of surgery
1) to 3) are not tests that are performed in routine clinical practice, so they must be performed after obtaining consent to participate in this study.

Registered date

2023

Year

11

Month

08

Day

Last modified on

2023

Year

11

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060174