UMIN-CTR Clinical Trial

Basic information
Public title	Intestinal Flora of ADPKD and Prostate Cancer
Acronym	IFPPC-study
Scientific Title	Intestinal Flora of ADPKD and Prostate Cancer
Scientific Title:Acronym	IFPPC-study
Region	Japan

Condition
Condition	Autosomal dominant polycystic kidney disease (ADPKD) Prostate Cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Intestinal flora is related to Inflammatory bowel disease, Chronic inflammation, Diabetes, cancer, and so on. However, the relation with chronic kidney disease is unclear. We will test Intestinal flora of progressive ADPKD or non-progressive ADPKD. Furthermore, to evaluate the relation of Intestinal flora and sex hormone, we will test Intestinal flora of prostate cancer patients at before and after the treatment of LH-RH.
Basic objectives2	Others
Basic objectives -Others	exploring
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Metagenomic analysis and Metabolome analysis of Intestinal flora before, 2weeks, 1months, 3months, 6months, 12months
Key secondary outcomes	Renal function Kidney volume PSA

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1: ADPKD 2: Newly diagnosed -prostate cancer patients who need hormonal therapy
Key exclusion criteria	1: Taking antibiotics or Immunosuppressive agent 2: Past history of operation of intestinal (without Endoscopic surgery ) 3: Severe intestinal disease 4: Without Informed consent 5: Assessed as unsuitable as research subjects by medical doctor
Target sample size	130

Research contact person
Last name of lead principal investigator	1st name Horie Middle name Last name Shigeo
Organization	Juntendo University, Graduate School of Medicine
Division name	Endowed course for the study of polycystic kidney disease
Zip code	113-8421
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	0358021227
Email	shorie@juntendo.ac.jp

Public contact
1st name of contact person	1st name Haruna Middle name Last name Kawano
Organization	Juntendo University, Graduate School of Medicine
Division name	Endowed course for the study of polycystic kidney disease
Zip code	113-8421
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	0358021227
Homepage URL
Email	harunase@juntendo.ac.jp

Sponsor
Institute	Endowed course for the study of polycystic kidney disease, Juntendo University, Graduate School of Medicine
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Center of GCP, Juntendo University Hospital
Address	3-1-1, Hongo, Bunkyo-ku, Tokyo , Japan
Tel	03-3813-3111
Email	kenkyu5858@juntendo.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	2016 Year 03 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	Enrolling by invitation
Date of protocol fixation	2015 Year 01 Month 01 Day
Date of IRB	2015 Year 02 Month 11 Day
Anticipated trial start date	2016 Year 03 Month 01 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	Intestinal flora

Management information
Registered date	2016 Year 02 Month 23 Day
Last modified on	2019 Year 04 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024402