UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025540 |
|---|---|
| Receipt number | R000029397 |
| Scientific Title | Association of cancer-related factors and 5-year survival rate in patients with hepatocellular carcinoma. |
| Date of disclosure of the study information | 2017/01/05 |
| Last modified on | 2020/03/25 19:54:50 |
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Basic information
Public title
Association of cancer-related factors and 5-year survival rate in patients with hepatocellular carcinoma.
Acronym
The observational retrospective study in patients with hepatocellular carcinoma.
Scientific Title
Association of cancer-related factors and 5-year survival rate in patients with hepatocellular carcinoma.
Scientific Title:Acronym
The observational retrospective study in patients with hepatocellular carcinoma.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We aim to evaluate the between cancer-related gene expression and clinical factors, and 5-year survival rate in patients with hepatocellular carcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
5-year survival rate
Key secondary outcomes
Recurrence and metastasis
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)The case that liver tissue specimen are storing St. Marianna University School of Medicine Human Tissue/Specimen Banking for a surgical operation in patients with hepatocellular carcinoma.
2)The patients include more than five years from a surgical operation (before 31 December 2011).
Key exclusion criteria
1)If the patients evaluate single nucleotide polymorphism (SNP), it has not approved the human genome/gene analysis research.
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | Matsumoto |
| Middle name | |
| Last name | Naoki |
Organization
St. Marianna University School of Medicine
Division name
Department of Pharmacology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa
TEL
044-977-8111
matsumoto@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Watanabe |
| Middle name | |
| Last name | Daiki |
Organization
St. Marianna University School of Medicine
Division name
Department of Pharmacology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
d2watanabe@marianna-u.ac.jp
Sponsor or person
Institute
Department of Pharmacology, St. Marianna University School of Medicine
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
The Institutional Review Board of St Marianna University
Address
2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa
Tel
044-977-8111
k-sienbu.mail@marianna-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
| 2017 | Year | 01 | Month | 05 | 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
79
Results
High EpCAM+CD90 group had higher risk of all-cause mortality compared with Low EpCAM+CD90 group in hepatocellular carcinoma (HCC) patients (hazard ratio [HR] 3.60, 95% confidence interval [CI], 1.18 to 11.01, p =0.025) with adjustment for potential confounders. In addition, recurrence event were significantly higher recurrence events after 2 years (HR 11.19, 95% CI 1.65 to 75.78, p =0.013) but not within 2 years from operation to the events (HR 0.84, 95% CI 0.33 to 2.18, p =0.721).
Results date posted
| 2020 | Year | 03 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age, men (%), mean BMI, HCV-carrier (%), and HBV- carrier (%) of seventy-nine hepatocellular carcinoma (HCC) patients were 66.9 (range: 41-84) year, 82.3 %, 23.1 kg/m2 (range: 16.3-34.1 kg/m2), 59.5 %, and 20.3 %, respectively.
Participant flow
To evaluate the expression of protein and mRNA, we used frozen liver tissue from the St. Marianna University School of Medicine tissue bank. We used samples by liver resection in Division of Gastroenterological and General Surgery, St. Marianna University School of Medicine Hospital first April 2003 to 30th November 2011. Of 88 hepatocellular carcinoma (HCC) patients, participants excluded postoperative less than 5 years (n = 9), finally this study include 79 patients.
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 06 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
Predictor variable
1) Protein expression of cancer stem cell markers
2) The mRNA expression of cancer-related genes
3) Nutritional status(Body weight, Controlling Nutritional Status(CONUT), Prognostic Nutritional Index(PNI), Grasgow Prognostic Score, Body Mass Index(BMI) and history of alcohol intake)
4) Single Nucleotide Polymorphism(SNP) of cancer stem cell markers
Management information
Registered date
| 2017 | Year | 01 | Month | 05 | Day |
Last modified on
| 2020 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029397
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