UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038703
Receipt number R000044125
Scientific Title Gut microbiome of gastroenterological cancer: An exhaustive prospective cohort study
Date of disclosure of the study information 2019/11/30
Last modified on 2023/11/30 11:22:00

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Basic information

Public title

Gut microbiome of gastroenterological cancer: An exhaustive prospective cohort study

Acronym

Gut microbiome of gastroenterological cancer: An exhaustive prospective cohort study

Scientific Title

Gut microbiome of gastroenterological cancer: An exhaustive prospective cohort study

Scientific Title:Acronym

Gut microbiome of gastroenterological cancer: An exhaustive prospective cohort study

Region

Japan


Condition

Condition

Gastroenterological cancer

Classification by specialty

Gastrointestinal surgery Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To analyze the association between gut microbiome and prognosis in gastroenterological cancer.

Basic objectives2

Others

Basic objectives -Others

To analyze the association between gut microbiome and prognosis in gastroenterological cancer.

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

To estimate 5-year overall survival in the difference of gut microbiome in gastroenterological cancer.

Key secondary outcomes

To evaluate the association between surgical outcomes and microbiome in the case of gastroenterological cancer
To evaluate the association between the efficacy of preoperative or postoperative treatment and microbiome in the case of gastroenterological cancer
To evaluate the association between surgical outcomes and microbiome in the case of gastroenterological cancer
To evaluate the perioperative complication
To evaluate the tumor infiltrating lymphocytes around the cancer and to investigate the association to microbiota, DNA, RNA or metabolite
To evaluate the association between the postoperative complication and microbiota, DNA, RNA or metabolite
To evaluate the association between complication and risk factor during preoperative treatment
To evaluate the surgical outcomes according to final tumor stages
To evaluate the association between the treatment outcome according to patient background and microbiota, DNA, RNA or metabolite
To evaluate the association among microbiota, DNA, RNA or metabolite in the cancer tissue, oral mucosa or blood tissue.
To evaluate to compare the microbiota, DNA, RNA or metabolite between part of cancer tissue and that of normal tissue.
To evaluate to compare the metabolite such as sulfur metabolite, lipid metabolite, sugar metabolite between part of cancer tissue and that of normal tissue.
To evaluate postoperative endoscopic polypectomy and association to microbiota, DNA, RNA or metabolite in the case of gastroenterological cancer surgery.
To evaluate the recurrence patterns and long-term outcomes and to investigate the association to microbiota, DNA, RNA or metabolite in the case of recurrence after gastroenterological cancer surgery.


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

over 18-year-old
confirming gastroenterological cancer pathologically
patients were recieved informed consent

Key exclusion criteria

judgement not to register suitably

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Itaru
Middle name
Last name Endo

Organization

Yokohama city university school of medicine

Division name

Department of gastroenterological surgery

Zip code

2360004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL

0457872650

Email

t196056a@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Miyuki
Middle name
Last name Onodera

Organization

Yokohama city university

Division name

Ethics Committee for Medical Research Involving Human Subjects

Zip code

2360004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL

0457872650

Homepage URL


Email

rinri@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama city university

Institute

Department

Personal name



Funding Source

Organization

no funding source

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

Yokohama city university

Address

3-9 Fukuura, Kanazawa-ku, Yokohama

Tel

0457872650

Email

rinri@yokohama-cu.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

2019 Year 11 Month 30 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

2019 Year 06 Month 07 Day

Date of IRB

2019 Year 08 Month 23 Day

Anticipated trial start date

2019 Year 10 Month 17 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

2027 Year 03 Month 31 Day


Other

Other related information

Compared the difference of gut microbiome and metaborome between tumor site and non-tumor site, follow the prognosis.


Management information

Registered date

2019 Year 11 Month 27 Day

Last modified on

2023 Year 11 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044125


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name