UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004613 |
|---|---|
| Receipt number | R000005507 |
| Scientific Title | Prospective research of the biomarkers associated with adjuvant chemotherapy in patients with resectable biliary tract cancer |
| Date of disclosure of the study information | 2010/11/24 |
| Last modified on | 2020/10/25 23:16:55 |
* 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 research of the biomarkers associated with adjuvant chemotherapy in patients with resectable biliary tract cancer
Acronym
A research of the biomarkers associated with adjuvant chemotherapy in patients with resectable biliary tract cancer
Scientific Title
Prospective research of the biomarkers associated with adjuvant chemotherapy in patients with resectable biliary tract cancer
Scientific Title:Acronym
A research of the biomarkers associated with adjuvant chemotherapy in patients with resectable biliary tract cancer
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify the biomarkers which correlate with the efficacy of adjuvant chemotherapy for biliary tract cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relapse-free survival
Key secondary outcomes
Overall survival
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
1) Surgicaly resected and histologically proven ductal pancreatic cancer
2) Age of more than 20 years
Oral intake is possible
3) ECOG performance status (PS) of 0 to 2
4) Oral intake is possible
5) Adequate organ function
6) Written informed
Key exclusion criteria
1)Intestinal pneumonia or lung fibrosis
2) No previous adjuvant therapy
3) Severe diarrhea
4) Severe mental disorder
5) Active infection
6) Severe complication disease
7) Sever postoperative complications
8) History of chest radiotherapy
9) intractable pleural or abdominal effusion
10) Distant metastasis
11) History of other active malignancy
12) Pregnacy or patient's hope to be pregnant
13) Inadequate physical condition, as diagnosed by primary physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Shibata |
Organization
University of Miyazaki Hospital
Division name
Department of Medical Oncology
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki, 889-1692, JAPAN
TEL
0985-85-1419
n-shiba@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Shibata |
Organization
University of Miyazaki Hospital
Division name
Department of Medical Oncology
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki, 889-1692, JAPAN
TEL
0985-85-1419
Homepage URL
n-shiba@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Department of Medical Oncology, University of Miyazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Yakult Honsha Co., Ltd
Yakult Central Institute
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
University of Miyazaki Hospital, Clinical Research Support Center
Address
5200 Kihara, Kiyotake, Miyazaki, 889-1692, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-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
宮崎大学医学部附属病院（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 24 | 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
50
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
Terminated
Date of protocol fixation
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective study
Management information
Registered date
| 2010 | Year | 11 | Month | 24 | Day |
Last modified on
| 2020 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005507
