UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026191
Receipt No. R000030090
Scientific Title A Novel diagnostic method using CDO1 gene methylation-Establishment of peritoneal lavage DNA cytology for gastric cancer
Date of disclosure of the study information 2017/02/17
Last modified on 2019/02/19

* 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 A Novel diagnostic method using CDO1 gene methylation-Establishment of peritoneal lavage DNA cytology for gastric cancer
Acronym A prospective case series study on peritoneal lavage DNA-cytology for gastric cancer
Scientific Title A Novel diagnostic method using CDO1 gene methylation-Establishment of peritoneal lavage DNA cytology for gastric cancer
Scientific Title:Acronym A prospective case series study on peritoneal lavage DNA-cytology for gastric cancer
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the usefulness of peritoneal lavage cytology by detecting CDO1 gene methylation in patients for gastric cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Concordance rate between conventional CY and DNA-CY
Key secondary outcomes Peritoneal relapse-free survival rate between conventional CY and DNA-CY

DNA CY1 rate in early gastric cancer

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) Histologically proven gastric cancer
2) With written informed consent before surgery
3) Preoperatively diagnosed as cStage I-IV
Key exclusion criteria Patients without preoperative informed consent
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keishi Yamashita
Organization Kitasato University School of Medicine
Division name Division of Advanced Surgical Oncology, Department of Research and Development Center for New Medical Frontiers
Zip code
Address 1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
TEL 042-778-8111
Email keishi23@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Harada
Organization Kitasato University School of Medicine
Division name Department of Surgery
Zip code
Address 1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
TEL 042-778-8111
Homepage URL
Email dm16025@st.kitasato-u.ac.jp

Sponsor
Institute Department of Surgery, Kitasato University School of Medicine
Institute
Department

Funding Source
Organization Department of Surgery, Kitasato University School of Medicine
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
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
2017 Year 02 Month 17 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 No longer recruiting
Date of protocol fixation
2016 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: A prospective case series study
Observational items: Details of peritoneal metastasis from gastric cancer, other clinicopathologic features

Management information
Registered date
2017 Year 02 Month 17 Day
Last modified on
2019 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030090

Research Plan
Registered date File name
2018/07/30 ⑤プロトコール.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.