UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044562
Receipt number R000050904
Scientific Title Clinical pathological gene research for the pathophysiology and diagnostic accuracy of pancreatic tumors
Date of disclosure of the study information 2021/06/16
Last modified on 2023/12/18 16:04:09

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Basic information

Public title

Clinical pathological gene research for the pathophysiology and diagnostic accuracy of pancreatic tumors

Acronym

Genetic research of pancreatic tumors

Scientific Title

Clinical pathological gene research for the pathophysiology and diagnostic accuracy of pancreatic tumors

Scientific Title:Acronym

Genetic research of pancreatic tumors

Region

Japan


Condition

Condition

Pancreatic tumor

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To elucidate of the mechanism of malignant transformation of pancreatic cancer and IPMN, this study analyzes the relationship between gene mutation and clinical factors of pancreatic cancer, its precancerous lesions and pancreatic tumors including Pan-IN and IPMN.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Positive rate of genetic markers that relate prognosis.

Key secondary outcomes

To identify clinical factors that relate prognosis.
Overall gene mutation rate and molecular marker expression rate.
Expression rate of gene mutations and molecular markers associated with each clinical factors.


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Pancreatic cancer patients.
Patients who underwent surgery or detailed examination for pancreatic tumor.
Control patients.

Key exclusion criteria

not applicable

Target sample size

350


Research contact person

Name of lead principal investigator

1st name Shinichi
Middle name
Last name Takano

Organization

University of Yamanashi

Division name

Division of gastroenterology and hepatology

Zip code

409-3898

Address

1110 Shomokato Chuo Yamanashi Japan

TEL

055-273-9584

Email

stakano@yamanashi.ac.jp


Public contact

Name of contact person

1st name Shinichi
Middle name
Last name Takano

Organization

University of Yamanashi

Division name

Division of gastroenterology and hepatology

Zip code

409-3898

Address

1110 Shomokato Chuo Yamanashi Japan

TEL

055-273-9584

Homepage URL


Email

stakano@yamanashi.ac.jp


Sponsor or person

Institute

University of Yamanashi
Division of gastroenterology and hepatology

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Yamanashi

Address

1110 Shomokato Chuo Yamanashi Japan

Tel

055-273-9065

Email

stakano@yamanashi.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

2021 Year 06 Month 16 Day


Related information

URL releasing protocol

https://onlinelibrary.wiley.com/doi/abs/10.1111/cas.15249

Publication of results

Partially published


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/abs/10.1111/cas.15249

Number of participants that the trial has enrolled

172

Results

The most common genetic abnormalities obtained were KRAS (82%), TP53 (57%), SMAD4 (19%), and RET (16%). Genetic abnormalities that could be markers for FDA-approved molecular-targeted drugs were found in 30 patients (20%) in 93 locations, and 14% of patients had abnormalities in genes related to homologous recombination repair, a potential marker for FOLFIRINOX, which is used in clinical practice.

Results date posted

2023 Year 12 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

A total of 161 patients (Stage I/II/III/IV=6/72/22/61) who underwent EUS-FNA for pancreatic cancer were included.

Participant flow

Patients who were able to give written consent for the study at the time of patient consultation were included in the study.

Adverse events

Nothing particular.

Outcome measures

Genetic abnormalities of biopsied samples.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2018 Year 11 Month 22 Day

Date of IRB

2018 Year 11 Month 22 Day

Anticipated trial start date

2018 Year 11 Month 22 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

In this study, we obtained 185 tissue samples from 172 patients with pancreatic cancer who underwent EUS-FNA or endoscopic biopsy of an invading tumor at the Yamanashi University hospital between July 2014 and December 2019. We then performed next-generation sequencing analysis on endoscopically-obtained FFPE samples from patients with pancreatic cancer to identify therapeutic targets and determine the clinical significance of these targets through comparisons with the clinical information of the patients.


Management information

Registered date

2021 Year 06 Month 16 Day

Last modified on

2023 Year 12 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050904


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name