UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027086
Receipt number R000031045
Scientific Title Gastrointestinal micro and mycobiome profile in chemotherapy and stem cell transplantation for hematological malignancies
Date of disclosure of the study information 2017/04/21
Last modified on 2020/04/24 13:58:04

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Basic information

Public title

Gastrointestinal micro and mycobiome profile in chemotherapy and stem cell transplantation for hematological malignancies

Acronym

Chiba micro-mycobiome study

Scientific Title

Gastrointestinal micro and mycobiome profile in chemotherapy and stem cell transplantation for hematological malignancies

Scientific Title:Acronym

Chiba micro-mycobiome study

Region

Japan


Condition

Condition

Hematological malignancies (acute leukemia and malignant lymphoma)

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

A cohort study to assess the the gantrointestinal micro and mycobiota diversity in patients with hematological malignancies who receive combination chemotherapy and stem cell transplantation

Basic objectives2

Others

Basic objectives -Others

Assess the relationship between microbiota diversity and patient characteristics, complications, treatment outcomes, and combination probiotic therapies.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Changes in gastrointestinal microbial diversity during combination chemaotherapy

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) 16 years old or older
2) Patients with Newly or previously diagnosed hematological malignancy who will initiate combination chemotherapy in hospitalized setting
3) More than 1 month chemotherapeutic interval is required in previously diagnosed patients

Key exclusion criteria

1) Patients who previously received chemotherapeutic agents within 1 month
2) Patients considered to be ineligible by physicians

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Chikako
Middle name
Last name Ohwada

Organization

Chiba University Hospital

Division name

Department of Hematology

Zip code

2608677

Address

1-8-1, Inohana, Chuo-ku, Chiba City, Chiba, Japan

TEL

043-222-7171

Email

chikako_ohwada@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Chikako
Middle name
Last name Ohwada

Organization

Chiba University Hospital

Division name

Department of Hematology

Zip code

2608677

Address

1-8-1, Inohana, Chuo-ku, Chiba City, Chiba, Japan

TEL

043-222-7171

Homepage URL


Email

chikako_ohwada@faculty.chiba-u.jp


Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

Chiba University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical research review board, Chiba University School of Medicine

Address

1-8-1 Inohana, Chuo-ku Chiba City, Chiba, JAPAN

Tel

043-222-7171

Email

igaku-rinri@office.chiba-u.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

2017 Year 04 Month 21 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

2017 Year 01 Month 19 Day

Date of IRB

2017 Year 01 Month 19 Day

Anticipated trial start date

2017 Year 04 Month 21 Day

Last follow-up date

2022 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Patients' stools are collected 4 times (before and after chemotherapy) during the chemotherapeutic course. Bacterial and fungus DNA are extracted, and inter-patient variety and longitudinal change of diversity are analyzed.


Management information

Registered date

2017 Year 04 Month 21 Day

Last modified on

2020 Year 04 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031045


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name