UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035672 |
|---|---|
| Receipt number | R000040634 |
| Scientific Title | Histological treatment effect of preoperative thrapy/prognostic prediction scoring system for pancreatic cancer -A retrospective observation study- |
| Date of disclosure of the study information | 2019/01/25 |
| Last modified on | 2021/01/26 16:32:36 |
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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
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
okada@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040634
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