UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045828 |
|---|---|
| Receipt number | R000051764 |
| Scientific Title | A Prospective Observational Study on Establishment of New Biomarkers to Compensate for Peritoneal Lavage Cytology in Pancreatic Cancer |
| Date of disclosure of the study information | 2021/10/22 |
| Last modified on | 2025/05/14 15:22:29 |
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Basic information
Public title
A Prospective Observational Study on Establishment of New Biomarkers to Compensate for Peritoneal Lavage Cytology in Pancreatic Cancer
Acronym
New Biomarkers to Compensate for Peritoneal Lavage Cytology in Pancreatic Cancer
Scientific Title
A Prospective Observational Study on Establishment of New Biomarkers to Compensate for Peritoneal Lavage Cytology in Pancreatic Cancer
Scientific Title:Acronym
New Biomarkers to Compensate for Peritoneal Lavage Cytology in Pancreatic Cancer
Region
| Japan |
Condition
Condition
Pancreatic Ductal Adenocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop new biomarkers using peritoneal lavage collected from patients with pancreatic cancer, which compensate for peritoneal lavage cytology.
Basic objectives2
Others
Basic objectives -Others
New biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prognostic impact of new biomarkers on disease-free survival
Key secondary outcomes
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients clinically diagnosed with pancreatic ductal adenocarcinoma
(2) Patients planned to undergo radical resection
(3) Patients with a PS (ECOG) of 0 or 1
(4) Patients expected to survive for more than 3 months from the initial treatment
(5) Patients with written informed consent
Key exclusion criteria
(1) Patients with serious comorbidities
(2) Patients with active multiple cancers
(3) Patients with mental disease interfering taking part in the trial
(4) Pregnant or breast-feeding women, or women suspected of being pregnant
(5) Patients who are judged unsuitable for the study by the principal investigator or sub-investigator
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Suenaga |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Surgery
Zip code
460-0001
Address
4-1-1 Sannomaru, Naka-ku, Nagoya, Japan
TEL
052-951-1111
suenaga.masaya.tk@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Suenaga |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Surgery
Zip code
460-0001
Address
4-1-1 Sannomaru, Naka-ku, Nagoya, Japan
TEL
052-951-1111
Homepage URL
suenaga.masaya.tk@mail.hosp.go.jp
Sponsor or person
Institute
Department of Surgery, National Hospital Organization Nagoya Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
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
National Hospital Organization IRB
Address
2-5-21 Higashigaoka, Meguro-Ku, Tokyo, Japan
Tel
03-5712-5050
700-kenkyu@mail.hosp.go.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 | 10 | Month | 22 | 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
192
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective Observational Study
Management information
Registered date
| 2021 | Year | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051764
