UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026647
Receipt number 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 2021/09/24 10:26:07

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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 or person

Institute

Wakayama medical university

Institute

Department

Personal name



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

54

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

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

2021 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 03 Month 31 Day

Date trial data considered complete

2021 Year 03 Month 31 Day

Date analysis concluded

2021 Year 08 Month 31 Day


Other

Other related information

nothing


Management information

Registered date

2017 Year 03 Month 22 Day

Last modified on

2021 Year 09 Month 24 Day



Link to view the page

Value
https://center6.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