UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042740
Receipt number R000048786
Scientific Title Evaluation of the utility of C. elegans-cancer screening test (N-NOSE) for patients with gastrointestinal cancer
Date of disclosure of the study information 2020/12/13
Last modified on 2022/12/15 15:28:18

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Basic information

Public title

Evaluation of the utility of C. elegans-cancer screening test (N-NOSE) for patients with gastrointestinal cancer

Acronym

Evaluation of the utility of C. elegans-cancer screening test (N-NOSE) for patients with gastrointestinal cancer

Scientific Title

Evaluation of the utility of C. elegans-cancer screening test (N-NOSE) for patients with gastrointestinal cancer

Scientific Title:Acronym

Evaluation of the utility of C. elegans-cancer screening test (N-NOSE) for patients with gastrointestinal cancer

Region

Japan


Condition

Condition

gastrointestinal cancer

Classification by specialty

Surgery in general Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This study aims to investigate the availability of C. elegans-cancer screening test (N-NOSE) for patients whose gastrointestinal cancer was performed with curative intent

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The change of the chemotaxis index before and after treatment

Key secondary outcomes

The association between the change of chemotaxis-index and the response for treatments


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Histologically diagnosed gastric or esophageal cancer

(2)20 years and over at the timing of registration

(3)ECOG Performance status(PS) of 0 or 1

(4)Organ function is preserved

(5)Curative resection is planned

(6)Written informed consent is obtained

Key exclusion criteria

(1)Synchronous or metachronous (within five years) multiple cancers, except for intraepithelial or intramucosal carcinoma cured by local therapy

(2)Active systemic infectious disease

(3)Unable to join due to his/her mental status or mental disorders

(4)Pregnancy, lactation, or intention to become pregnant during this study

(5)Whom judged by the investigator, sub-investigator, or attending physician to be ineligible for enrollment in the study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yasuyuki
Middle name
Last name Seto

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Gastrointestinal Surgery

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-5411

Email

seto-tky@umin.ac.jp


Public contact

Name of contact person

1st name Sayuri
Middle name
Last name Iitaka

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Gastrointestinal Surgery

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-5411

Homepage URL


Email

iitaka-spr@umin.ac.jp


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

HIROTSU Bio Science

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Office for Human Research Studies, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

Tel

03-5841-0818

Email

ethics@m.u-tokyo.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

2020 Year 12 Month 13 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

60

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

No longer recruiting

Date of protocol fixation

2020 Year 07 Month 08 Day

Date of IRB

2020 Year 07 Month 21 Day

Anticipated trial start date

2020 Year 10 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This research is an observational study. Patients who visit our hospital from 1st October 2020 to 31st March 2022 will be included when they meet the eligibility criteria. Urine samples are obtained for N-NOSE from all of them.


Management information

Registered date

2020 Year 12 Month 13 Day

Last modified on

2022 Year 12 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048786


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name