UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030757
Receipt number R000035123
Scientific Title Comprehensive gene analysis for the specimen of pancreatic cancer obtained by EUS-FNA
Date of disclosure of the study information 2018/01/20
Last modified on 2024/01/15 14:04:39

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Basic information

Public title

Comprehensive gene analysis for the specimen of pancreatic cancer obtained by EUS-FNA

Acronym

Comprehensive gene analysis for the specimen of pancreatic cancer

Scientific Title

Comprehensive gene analysis for the specimen of pancreatic cancer obtained by EUS-FNA

Scientific Title:Acronym

Comprehensive gene analysis for the specimen of pancreatic cancer

Region

Japan


Condition

Condition

Pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the acquision rate of the specimen of pancreatic cancer obtained by EUS-FNA for comprehensive gene analysis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Acquision rate of the specimen obtained by EUS-FNA for comprehensive gene analysis.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

The specimen of pancreatic cancer obtained by EUS-FNA of the first pass is used for this study.

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

1. More than 20 years old
2. Hypovascular pancreatic tumor
3. Necessary of EUS-FNA for diagnosis
4. Performance status with more than 2
5. Without severe complication
6. Acquisition of patients agreement

Key exclusion criteria

1. Presence of interveneous vesseles in the puncture line during EUS-FNA
2. High risk of bleeding
3. Difficulty of performing EUS
4. Without informed consent
5. Deemed ineligible

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Mamoru
Middle name
Last name Takenaka

Organization

Kindai University Faculty of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

589-8511

Address

377-2, Ohno-Higashi, Osaka-Sayama, Osaka, Japan

TEL

072-366-0221

Email

mamoxyo45@gmail.com


Public contact

Name of contact person

1st name Ken
Middle name
Last name Kamata

Organization

Kindai University Faculty of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

589-8511

Address

377-2, Ohno-Higashi, Osaka-Sayama, Osaka, Japan

TEL

072-366-0221

Homepage URL


Email

ky11@leto.eonet.ne.jp


Sponsor or person

Institute

Kindai University

Institute

Department

Personal name



Funding Source

Organization

Kindai University

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

Kindai Univercity faculty of medicine

Address

Osaka

Tel

0722201181

Email

ky11@leto.eonet.ne.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

2018 Year 01 Month 20 Day


Related information

URL releasing protocol

N/A

Publication of results

Published


Result

URL related to results and publications

N/A

Number of participants that the trial has enrolled

50

Results

The collection rate of EUS-FNB specimens suitable for comprehensive cancer panels using deep sequencing was 93.6%. Mutation in p53 and Smad4 were positively and negatively associated, respectively, with disease control at the initial evaluation. The median time to progression in 15 patients with p53 and without Smad4 mutations was 182.0 days; whereas, it was 92.5 days in other 10 patients; this difference was significant (p = 0.020).



Results date posted

2024 Year 01 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Fifty patients with suspected pancreatic cancer presenting consecutively at the Kindai University Hospital between January 2018 and January 2019 were enrolled.

Participant flow

Cancerous tissues from EUS-FNB were obtained from each tumor and subjected to histological examination and mutational analysis.

Adverse events

No adverse events

Outcome measures

The primary endpoint was the collection rate of EUS-FNB specimens suitable for comprehensive cancer panels using deep sequencing. Clinical history and genetic variations between the disease control and progressive disease groups of patients on chemotherapy were evaluated as secondary endpoints.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 07 Month 18 Day

Date of IRB

2018 Year 01 Month 01 Day

Anticipated trial start date

2018 Year 01 Month 10 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 10 Day

Last modified on

2024 Year 01 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035123


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name