UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041401 |
|---|---|
| Receipt number | 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 | 2025/02/14 16:47:53 |
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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
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
mfutamur@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
120
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Some parts of organs are going now
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 | 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
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047213
