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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026647
Receipt No. R000030600
Scientific Title A prospective study of the usefulness of circulating tumor DNA as biomarker during neoadjuvant chemotherapy for the borderline-resectable pancreatic cancer
Date of disclosure of the study information 2017/04/01
Last modified on 2019/04/05

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Basic information
Public title A prospective study of the usefulness of circulating tumor DNA as biomarker during neoadjuvant chemotherapy for the borderline-resectable pancreatic cancer
Acronym A prospective study of the usefulness of ctDNA as biomarker during NAC for the BR pancreatic cancer
Scientific Title A prospective study of the usefulness of circulating tumor DNA as biomarker during neoadjuvant chemotherapy for the borderline-resectable pancreatic cancer
Scientific Title:Acronym A prospective study of the usefulness of ctDNA as biomarker during NAC for the BR pancreatic cancer
Region
Japan

Condition
Condition borderline- resectable pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose is that measuring ctDNA is usefulness method for determining treatment effect on borderline-resectable pancreatic cancer patients who were performed neoadjuvant chemotherapy.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The correlation of the dose of ctDNA on before and after neoadjuvant chemotherapy and the relapse-free survival
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria The patients are planned to treat neoadjuvant chemotherapy according our protocol.
Key exclusion criteria The patients follow our protocol.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hiroki
Middle name
Last name Yamaue
Organization Wakayama medical university
Division name 2nd department of surgery
Zip code 641-8510
Address 811-1 Kimiidera Wakayama, Japan
TEL 0734410613
Email yuji-kh@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Yuji
Middle name
Last name Kitahata
Organization 2nd department of surgery, Wakayama medical university
Division name 2nd department of surgery
Zip code 641-8510
Address 811-1 Kimiidera Wakayama, Japan
TEL 0734410613
Homepage URL
Email yuji-kh@wakayama-med.ac.jp

Sponsor
Institute Wakayama medical university
Institute
Department

Funding Source
Organization research expense
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Wakayama medical university
Address 811-1 Kimiidera Wakayama city
Tel 0734472300
Email wa-rinri@wakayama-med.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
2017 Year 04 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 Open public recruiting
Date of protocol fixation
2017 Year 02 Month 08 Day
Date of IRB
2017 Year 02 Month 08 Day
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2017 Year 03 Month 22 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030600

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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