UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000284 |
|---|---|
| Receipt number | 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 | 2023/11/30 18:16:53 |
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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 | Hirotsugu |
| Middle name | |
| Last name | Uemura |
Organization
Kinki University
Division name
School of Medicine, Department of Urology
Zip code
589-8511
Address
Onohigashi 377-2, Osakasayama, Osaka
TEL
+81723660221
huemura@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Uemura |
Organization
Kinki University
Division name
School of Medicine, Department of Urology
Zip code
589-8511
Address
Onohigashi 377-2, Osakasayama, Osaka
TEL
+81723660221
Homepage URL
huemura@med.kindai.ac.jp
Sponsor or person
Institute
A society for the study of prognostic factors forecasting the metastasis of renal cell carcinoma
Institute
Department
Personal name
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
Kindai University Hospital
Address
377-2 Ohnohigashi Osakasayama, 589-8511, Osaka, Japan
Tel
+81723660221
huemura@med.kindai.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
| 2012 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
UMIN-ICDS
Publication of results
Unpublished
Result
URL related to results and publications
UMIN-ICDS
Number of participants that the trial has enrolled
210
Results
# of pts enrolled: 210
# of pts available:205 (excluded 5)
# of pts analyzed:195
# of pts not recurrent:146
# of pts lost follow:28
Results date posted
| 2023 | Year | 11 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
pT1bN0M0 renal cell carcinoma patients
Participant flow
After enrollment, clinical observation
Adverse events
not available
Outcome measures
recurrence or metastasis rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2002 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2002 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2002 | Year | 06 | 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
| 2023 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000337
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