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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023622
Receipt No. R000027205
Scientific Title Molecular alterations and clinicopathological features in sporadic duodenal adenocarcinoma
Date of disclosure of the study information 2016/08/15
Last modified on 2018/08/16

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Basic information
Public title Molecular alterations and clinicopathological features in sporadic duodenal adenocarcinoma
Acronym Molecular alterations in duodenal adenocarcinoma
Scientific Title Molecular alterations and clinicopathological features in sporadic duodenal adenocarcinoma
Scientific Title:Acronym Molecular alterations in duodenal adenocarcinoma
Region
Japan

Condition
Condition Primary extra-ampullary duodenal adenocarcinoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To clarify the molecular alterations in duodenal adenocarcinoma
Basic objectives2 Others
Basic objectives -Others To clarify the association between clinicopathological features including mucin phenotype and molecular alterations in duodenal adenocarcinoma
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Molecular analyses in duodenal adenocarcinoma
Key secondary outcomes Association between clinicopathological features including mucin phenotype and molecular alterations in duodenal adenocarcinoma

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) Primary extra-ampullary duodenal adenocarcinoma
Key exclusion criteria 1) Patients with a known familial cancer syndrome including familial adenomatous polyposis
2) Patients who have determined by
the physicians to have any reasons of unqualified
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroto Miwa
Organization Hyogo College of Medicine
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya
TEL 0798-45-6665
Email miwahgi@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jiro Watari
Organization Hyogo College of Medicine
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya
TEL 0798-45-6662
Homepage URL
Email watarij@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine,
Division of Gastroenterology, Department of Internal Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Aichi Cancer Center Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 08 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
Incidences of MSI, KRAS/BRAF/GNAS mutations, and CpG island methylator phenotype (CIMP) were 61.3%, 34.4%/3.1%/6.5%, and 28.1%, respectively. However, no significant associations between clinicopathological features and KRAS/BRAF/GNAS mutations or CIMP were found. Non-ampullary duodenal adenocarcinomas (NADCs) with histologically non-well differentiated-type and in the 1st portion were significantly associated with the late stages (stages III-IV) (P=0.006 and P=0.003, respectively). Mixed G-type NADC tended to be observed in the 1st portion, in the late stages (p=0.09 for each) and to express PD-L1 in cancer cells (P=0.06). Although there was no significant association between MSI and PD-L1 expression, histologically non-well differentiated-type was an independent predictor of PD-L1 expression in both cancer cells (OR=25.05, 95% CI=1.22-513.85, P=0.04) and immune cells (OR=44.14, 95% CI=1.96-995.97, P=0.02). The late stages (HR=24.86, 95% CI=2.58-411.18, P=0.005) and MSI (HR=10.18, 95% CI=1.17-114.06, P=0.03) were predictive factors of worse overall survival in the Cox proportional hazards regression model. 
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
2016 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 08 Month 31 Day

Other
Other related information No special instruction

Management information
Registered date
2016 Year 08 Month 14 Day
Last modified on
2018 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027205

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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