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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041401
Receipt No. R000047213
Scientific Title Evaluation of neoadjuvant therapy by Nematode-NOSE(N-NOSE) using C. elegans
Date of disclosure of the study information 2020/08/12
Last modified on 2020/08/12

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Basic information
Public title Evaluation of neoadjuvant therapy by Nematode-NOSE(N-NOSE) using C. elegans
Acronym Evaluation of NAC by C.elegans
Scientific Title Evaluation of neoadjuvant therapy by Nematode-NOSE(N-NOSE) using C. elegans
Scientific Title:Acronym Evaluation of NAC by C.elegans
Region
Japan

Condition
Condition Esopahgeal cancer, Gastric cancer, Colorectal cancer, Pancreatic cancer, Breast Cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evalutae the efficacy of neoadjuvan therapy by N-NOSE using C. elegans
Basic objectives2 Others
Basic objectives -Others Measurement of chemotactic indices using urne from the patients
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes ROC-ACU for IRC (chemotaxix index reduction score)
Key secondary outcomes 1. ROC-AUC for CR by IRS, 2. ROC-AUC accorfing to the following deficitions) 1)IRR1(Preop-Pretreatment), 2)IRR2 (Postop-Preop), 3)IRR4(Post op-Pretreatment, 3.Image, Tumor marker, 4.Patholog, 5. DFS, OS


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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients who undertake neoadjuvant therapy (Chemo, Radiotherapy) at Gifu Univ. 2.Patients more than 20 3.Patients 0ver 70 is applicable in the patient agree to participate in this study, 4.Pattients (Esophageal, gastric, colorectal, pancreatic, breast cancer) who are going to take neoadjuvant therapy (including conversion cases), 5.Any cases taking clinical trials are applicable if this study doesn't dusturb the protocol. 6.Participants (and/or the family) agree to participate in this study.
Key exclusion criteria 1.No indication for neoadjuvant therapy, 2.No agreement by the patient, 3.Active duplicated cancer (synchronous or another cancer less than 5 y. 4.Severe medical complications, 5.Severe systhemic disease and HIV. 6.Pregnant or lactating 7.Severe mental disorder 8.Urinary tract infection
Target sample size 167

Research contact person
Name of lead principal investigator
1st name Kazuhiro
Middle name
Last name Yoshida
Organization Gifu University, Graduate School of Medicine
Division name Department of Surgcal Oncology
Zip code 501-1194
Address Yanagido 1-1, Gifu, Gifu Pref
TEL 0582306000
Email mfutamur@gifu-u.ac.jp

Public contact
Name of contact person
1st name Manabu
Middle name
Last name Futamura
Organization Gifu University, Graduate School of Medicine
Division name Department of Surgcal Oncology
Zip code 501-1194
Address Yanagido 1-1, Gifu, Gifu Pref
TEL 0582306000
Homepage URL
Email mfutamur@gifu-u.ac.jp

Sponsor
Institute Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization HIROTSU Bioscience
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 Gifu University
Address Yanagido 1-1, Gifu, Gifu Pref
Tel +81582306000
Email mfutamur@gifu-u.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 08 Month 12 Day

Related information
URL releasing protocol Not done
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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 15 Day
Date of IRB
2020 Year 08 Month 05 Day
Anticipated trial start date
2020 Year 08 Month 17 Day
Last follow-up date
2024 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No

Management information
Registered date
2020 Year 08 Month 12 Day
Last modified on
2020 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047213

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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