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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007684
Receipt No. R000009059
Scientific Title Clinical significance of genetic diagnosis of free cancer cells in peritoneal lavage fluids obtained from gastric cancer surgery: Results from a prospective multicenter clinical trial.
Date of disclosure of the study information 2012/04/09
Last modified on 2012/04/06

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Basic information
Public title Clinical significance of genetic diagnosis of free cancer cells in peritoneal lavage fluids obtained from gastric cancer surgery: Results from a prospective multicenter clinical trial.
Acronym Clinical significance of genetic diagnosis with peritoneal lavage fluids.
Scientific Title Clinical significance of genetic diagnosis of free cancer cells in peritoneal lavage fluids obtained from gastric cancer surgery: Results from a prospective multicenter clinical trial.
Scientific Title:Acronym Clinical significance of genetic diagnosis with peritoneal lavage fluids.
Region
Japan

Condition
Condition Clinically serosal-invaded gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 TThe purpose of this study is to define the clinical significance of the molecular analysis of peritoneal lavage fluid in patients with gastric cancer in a multicenter prospective trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Patient survival and peritoneal lavage genetic diagnosis
Key secondary outcomes Peritoneal recurrence-free survival and genetic diagnosis

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Genetic diagnosis was introduced for peritoneal lavage diagnosis.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1, Histological confirmation of gastric cancer
2, Existence of serosa-invading tumor as a preoperative diagnosis
3, The absence of non-curative factors
4, No severe medical conditions
Key exclusion criteria 1, No other active cancer
2, No active hemorrhage/bleeding
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Fujiwara
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Surgery
Zip code
Address 1-3-3, Nakamichi, Hogashinariku, Osaka
TEL +81-6-6972-1181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Fujiwara
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Surgery
Zip code
Address
TEL +81-6-6972-1181
Homepage URL
Email

Sponsor
Institute Department of Gastroenterological Surgery, Osaka University
Institute
Department

Funding Source
Organization Department of Gastroenterological Surgery, Osaka University
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
2012 Year 04 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2007 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
2011 Year 05 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 02 Month 01 Day
Date analysis concluded
2012 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 04 Month 06 Day
Last modified on
2012 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009059

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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