UMIN-CTR Clinical Trial

Basic information
Public title	Histological treatment effect of preoperative thrapy/prognostic prediction scoring system for pancreatic cancer -A retrospective observation study-
Acronym	NAT-PC scoring study
Scientific Title	Histological treatment effect of preoperative thrapy/prognostic prediction scoring system for pancreatic cancer -A retrospective observation study-
Scientific Title:Acronym	NAT-PC scoring study
Region	Japan

Condition
Condition	Pancreatic Cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To establish a scoring system to predict the histological treatment effect and prognosis of preoperative treatment (chemotherapy/chemoradiotherapy) for pancreatic cancer and to verify its effectiveness in our case.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the prediction ability of treatment effect by scoring system with tumor marker (CA19-9, DUPAN-2), tumor size, whole tumor ADC value on diffusion-weighted MRI, and SUVmax value.
Key secondary outcomes	To evaluate the prediction ability of prognosis by scoring system with tumor marker (CA19-9, DUPAN-2), tumor size, whole tumor ADC value on diffusion-weighted MRI, and SUVmax value.

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	The patients who underwent preoperative treatment and surgery, and examination including tumor marker (CA19-9, DUPAN-2), MD-CT, diffusion weighted MRI, PET-CT prior to and after preoperative treayment regardless of tumor resectability.
Key exclusion criteria	Those who do not fall under the above.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Ken-ichi Middle name Last name Okada
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	Wakayama city, kimiidera, 811-1
TEL	073-441-0613
Email	okada@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Ken-ichi Middle name Last name Okada
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	Wakayama city, kimiidera, 811-1
TEL	073-441-0613
Homepage URL
Email	okada@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	none
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	IRB of Wakayama Medical University
Address	Wakayama City, Kimiidera 811-1
Tel	0734472300
Email	okada@wakayama-med.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2484
Org. issuing International ID_1	IRB in Wakayama Medical University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 25 Day

Related information
URL releasing protocol	ar.iialjournals.org
Publication of results	Published

Result
URL related to results and publications	Anticancer Research July 2020, 40(7)4033-4040
Number of participants that the trial has enrolled	28
Results	The favorable factors were counted as one point. The integrated point equal to and more than 4 was categorized to high score group. Results: OS and RFS in the patients was greater in patients with high score (n=11) than with low score (n=18; log-rank test P=0.03/0.028). Pathological N0 status (P<0.05) and histological response of more than IIb (P<0.05) were found at a significantly higher incidence in high score group.
Results date posted	2021 Year 01 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 07 Month 01 Day
Baseline Characteristics	Pancreatic cancer
Participant flow	Retrospective study with electric medical record
Adverse events	none
Outcome measures	Evaluation of prognostic predictability
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 11 Month 16 Day
Date of IRB	2019 Year 02 Month 19 Day
Anticipated trial start date	2019 Year 01 Month 25 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information	none

Management information
Registered date	2019 Year 01 Month 25 Day
Last modified on	2021 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040634