UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042746 |
|---|---|
| Receipt number | R000048737 |
| Scientific Title | Prospective observational study for the prediction of adverse events of triplet chemotherapy for pancreatic cancer and colorectal cancer by genetic polymorphisms. |
| Date of disclosure of the study information | 2020/12/15 |
| Last modified on | 2024/01/12 14:29:05 |
* 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
Prospective observational study for the prediction of adverse events of triplet chemotherapy for pancreatic cancer and colorectal cancer by genetic polymorphisms.
Acronym
The prediction of adverse events of triplet chemotherapy for pancreatic cancer and colorectal cancer by genetic polymorphisms.
Scientific Title
Prospective observational study for the prediction of adverse events of triplet chemotherapy for pancreatic cancer and colorectal cancer by genetic polymorphisms.
Scientific Title:Acronym
The prediction of adverse events of triplet chemotherapy for pancreatic cancer and colorectal cancer by genetic polymorphisms.
Region
| Japan |
Condition
Condition
pancreatic cancer and colorectal cancer
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To analyze the predictors of adverse events of triplet chemotherapy for pancreatic cancer and colorectal cancer by genetic polymorphisms.
Basic objectives2
Others
Basic objectives -Others
The prediction of adverse events
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Search for the predictors of adverse events
Key secondary outcomes
Search for the predictors of therapeutic effects
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
Patients with pancreatic cancer and colorectal cancer (resectable or unresectable)in accordance with the following criteria
1)no gender
2)age over 20 years old
3)the patients who gained written consent by the patient's free will with sufficient understanding after receiving sufficient explanation for the participation of this study
4)the patients who are scheduled to receive or are undergoing any of the following treatments a) to c)
a)triplet chemotherapy (FOLFIRINOX therapy for pancreatic cancer or FOLFOXIRI therapy for colorectal cancer)
b)gemcitabine plus nab-PTX therapy for pancreatic cancer
c)FOLFIRI therapy or FOLFOX therapy for colorectal cancer
Key exclusion criteria
Nothing
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nagano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836-22-2264
hnagano@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Gen |
| Middle name | |
| Last name | Kanesada |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836-22-2264
Homepage URL
gen021eb@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka International Cancer Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center For Clinical Research, Yamaguchi University Hospital
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
Tel
0836-22-2428
me223@yamaguchi-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
山口大学大学院 消化器・腫瘍外科学
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 15 | 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
| 2020 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Adverse events, including neutropenia, are frequently observed in patients undergoing triplet chemotherapy for pancreatic cancer and colorectal cancer. If it becomes possible to analyze the predictors of adverse events by genetic polymorphisms, we believe that it will lead to improvement of therapeutic effect.
Management information
Registered date
| 2020 | Year | 12 | Month | 14 | Day |
Last modified on
| 2024 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048737
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
