UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045997 |
|---|---|
| Receipt number | R000052506 |
| Scientific Title | Study on the usefulness of novel excision repair cross-complementation group-1 (ERCC-1) antibody for predicting the therapeutic effect of FOLFIRINOX therapy for pancreatic cancer |
| Date of disclosure of the study information | 2021/11/06 |
| Last modified on | 2023/11/15 18:21:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on the usefulness of novel excision repair cross-complementation group-1 (ERCC-1) antibody for predicting the therapeutic effect of FOLFIRINOX therapy for pancreatic cancer
Acronym
Study on the usefulness of novel ERCC-1 antibody for predicting the therapeutic effect of FOLFIRINOX therapy for pancreatic cancer
Scientific Title
Study on the usefulness of novel excision repair cross-complementation group-1 (ERCC-1) antibody for predicting the therapeutic effect of FOLFIRINOX therapy for pancreatic cancer
Scientific Title:Acronym
Study on the usefulness of novel ERCC-1 antibody for predicting the therapeutic effect of FOLFIRINOX therapy for pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1. To investigate whether the novel anti-ERCC1 antibody is more specific than the existing antibody in the expression of ERCC-1 in pancreatic cancer.
2. To clarify whether the RNA expression level of anti-ERCC-1 antibody or ERCC1 correlates with the effect and prognosis of chemotherapy for pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Ratio of new anti-ERCC-1 antibody and conventional anti-ERCC-1 antibody immunohistochemical staining in surgical specimens
2. Correlation between the expression level of anti-ERCC-1 antibody and ERCC1 RNA in surgical specimens
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with pancreatic cancer at Nagasaki University Hospital between December 1, 2014 and March 31, 2024
2. Patients with residual specimens who underwent pathological examination at the time of diagnosis
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Takahashi |
Organization
Nagasaki University
Division name
Department of Gastroenterology and Hepatology
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki 852-8501, JAPAN
TEL
095-819-7481
takapochi0809@gmail.com
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Takahashi |
Organization
Nagasaki University
Division name
Department of Gastroenterology and Hepatology
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki 852-8501, JAPAN
TEL
095-819-7481
Homepage URL
takapochi0809@gmail.com
Sponsor or person
Institute
Nagasaki 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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken,Japan
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.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 | 11 | Month | 06 | 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
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 11 | Month | 06 | Day |
Last modified on
| 2023 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052506
