UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041786
Receipt number R000047693
Scientific Title Monitoring of KRAS-mutated cell-free DNA in pancreatic cancer patients with neoadjuvant treatment
Date of disclosure of the study information 2020/11/01
Last modified on 2020/09/14 14:44:56

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Basic information

Public title

Monitoring of KRAS-mutated circulating tumor DNA in pancreatic cancer patients with neoadjuvant treatment

Acronym

Monitoring of ctDNA in pancreatic cancer

Scientific Title

Monitoring of KRAS-mutated cell-free DNA in pancreatic cancer patients with neoadjuvant treatment

Scientific Title:Acronym

Monitoring of ctDNA in pancreatic cancer

Region

Japan


Condition

Condition

pancreatic ductal adenocarcinoma

Classification by specialty

Hematology and clinical oncology Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the impact of KRAS-mutated cell-free DNA on the clinical course of pancreatic ductal adenocarcinoma

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Disease free survival on 6 months after surgery

Key secondary outcomes

-Overall survival
-Disease free survival
-R0 resection
-Serum CA19-9
-Pathological response


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

-Histologically confirmed pancreatic ductal adenocarcinoma
-Planned for neoadjuvant treatment
-ECOG performance status 0 or 1
-No history of any treatment for pancreatic ductal adenocarcinoma

Key exclusion criteria

-Administration of immunosuppressive agent
-Severe organ dysfunction
-Severe infection
-Pregnancy
-Double cancer
-Investigator judgement that the patient should not participate for any reason.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Horochika
Middle name
Last name Toyama

Organization

Kobe University Hospital

Division name

Hepato-Biliary-Pancreatic Surgery

Zip code

6500017

Address

7-5-2 Kusunoki-cho Chuo-ku Kobe

TEL

078-382-6302

Email

toyama@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Sachiyo
Middle name
Last name Shirakawa

Organization

Kobe University Hospital

Division name

Hepato-Biliary-Pancreatic Surgery

Zip code

650017

Address

7-5-2 Kusunoki-cho Chuo-ku Kobe

TEL

078-382-6302

Homepage URL


Email

sachiyo@pearl.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University

Institute

Department

Personal name



Funding Source

Organization

Kobe University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical ethics committee of Kobe University

Address

7-5-2 Kusunoki-cho Chuo-ku Kobe

Tel

078-382-6999

Email

k9shien@med.kobe-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

神戸大学病院


Other administrative information

Date of disclosure of the study information

2020 Year 11 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

Preinitiation

Date of protocol fixation

2020 Year 10 Month 09 Day

Date of IRB


Anticipated trial start date

2020 Year 11 Month 15 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study


Management information

Registered date

2020 Year 09 Month 14 Day

Last modified on

2020 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047693


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name