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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000284
Receipt No. R000000337
Scientific Title The study of clinical means of detcting circulating cancer cells on T1b-renal cell carcinoma
Date of disclosure of the study information 2012/06/01
Last modified on 2014/05/16

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Basic information
Public title The study of clinical means of detcting circulating cancer cells on T1b-renal cell carcinoma
Acronym The study of clinical means of detcting circulating cancer cells on T1b-renal cell carcinoma
Scientific Title The study of clinical means of detcting circulating cancer cells on T1b-renal cell carcinoma
Scientific Title:Acronym The study of clinical means of detcting circulating cancer cells on T1b-renal cell carcinoma
Region
Japan

Condition
Condition Renal cell carccinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Prospective analysis of clinical relevance as a valuable prognostic
factor for detection of circulation Cad-6/CA9 positive cells in patients with renal cell carcinoma.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.Relationship between detection of circulating Cad-6/CA-9 positive cells and clinicopathological factors in renal cell carcinoma.
2.Relationship between detection of circulating Cad-6/CA-9 positive cells and metastasis in renal cell carcinoma.
3.Difference in detection rate of circulation Cad-6 and CA9 positive cells according to surgical approaches.
Key secondary outcomes

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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients who can understand the explanation for obtaining informed consent and who are capable of giving informed consent.
2.Patients who have been informed that they have renal cell carcinoma (RCC) and from whom written informed consent to particiapte in the study has been obtained.
3.Performance Status(JCOG):0-2
4.Age: 20<=, 80>=
Key exclusion criteria 1.Patients with active multiple cancers.
2.Patients received partial nephrectomy or tumor enucleation.
3.Patient of HBV and/or HCV infection.
4.Patients judged inappropriate by the physician.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotsugu Uemura
Organization Kinki University
Division name School of Medicine, Department of Urology
Zip code
Address Onohigashi 377-2, Osakasayama, Osaka
TEL 072-366-0221
Email huemura@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotsugu Uemura
Organization Kinki University
Division name School of Medicine, Department of Urology
Zip code
Address Onohigashi 377-2, Osakasayama, Osaka
TEL 072-366-0221
Homepage URL
Email rcc-yogo@med.kindai.ac.jp

Sponsor
Institute A society for the study of prognostic factors forecasting the metastasis of renal cell carcinoma
Institute
Department

Funding Source
Organization Osaka Cancer Research Fundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 06 Month 01 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
2002 Year 04 Month 19 Day
Date of IRB
Anticipated trial start date
2002 Year 05 Month 01 Day
Last follow-up date
2015 Year 04 Month 01 Day
Date of closure to data entry
2015 Year 04 Month 01 Day
Date trial data considered complete
2015 Year 04 Month 01 Day
Date analysis concluded
2016 Year 04 Month 01 Day

Other
Other related information Prospective case-control observation study

Management information
Registered date
2005 Year 11 Month 16 Day
Last modified on
2014 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000337

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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