UMIN-CTR Clinical Trial
| Recruitment status | Terminated |
| Unique ID issued by UMIN | UMIN000002286 |
| Receipt No. | R000002779 |
| Scientific Title | Clinical significance of novel serum markers for the diagnosis, staging, and the prediction of prognosis in patients with renal cell carcinoma |
| Date of disclosure of the study information | 2009/08/15 |
| Last modified on | 2020/08/14 (Ver. 4) |
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| Basic information | ||
| Public title | Clinical significance of novel serum markers for the diagnosis, staging, and the prediction of prognosis in patients with renal cell carcinoma | |
| Acronym | Clinical significance of novel serum markers in renal cell carcinoma | |
| Scientific Title | Clinical significance of novel serum markers for the diagnosis, staging, and the prediction of prognosis in patients with renal cell carcinoma | |
| Scientific Title:Acronym | Clinical significance of novel serum markers in renal cell carcinoma | |
| Region |
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| Condition | ||
| Condition | Renal cell carcinoma | |
| Classification by specialty |
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| Classification by malignancy | Malignancy | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | It would be economically of great benefit to find predictors for renal cell carcinoma diagnosis, staging, and prognosis more accurately. The aim of our study is to evaluate the utility of serum marker such as cytokines, MMPs and angiogenesis-related marker, for improving renal cell carcinoma diagnosis, staging, and prediction of prognosis. |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | To evaluate the association between serum markers and 1)presence or absence of renal cell carcinoma, 2)cinical staging, 3)pathological staging (TNM clasification), 4) prognosis |
| 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 | |
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| Interventions/Control_7 | |
| Interventions/Control_8 | |
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| Interventions/Control_10 | |
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | The patients who will undergo the operation of renal cell carcinoma and the patients who were followed after the operation of renal cell carcinoma | |||
| Key exclusion criteria | The patients who did not agree with the purpose of this study | |||
| Target sample size | 500 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Keio University School of Medicine | ||||||
| Division name | Department of Urology | ||||||
| Zip code | 1608582 | ||||||
| Address | 35 Shinanomachi Shinjuku-ku, Tokyo | ||||||
| TEL | 0333531211 | ||||||
| moya3563@yahoo.co.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Keio University School of Medicine | ||||||
| Division name | Department of Urology | ||||||
| Zip code | 1608582 | ||||||
| Address | 35Shinanomachi Shinjuku-ku | ||||||
| TEL | 0333531211 | ||||||
| Homepage URL | |||||||
| moya3563@yahoo.co.jp | |||||||
| Sponsor | |
| Institute | Department of Urology, Keio University School of Medicine |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Department of Urology, Keio University School of Medicine |
| Organization | |
| Division | |
| Category of Funding Organization | Self funding |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Ethics Committee of KEIO |
| Address | 35Shinanomachi Shinjuku-ku |
| Tel | 03-5363-3503 |
| med-rinri-jimu@adst.keio.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 | |
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| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | http://www.keio-urology.jp/ |
| Publication of results | Unpublished |
| Result | |||||||
| URL related to results and publications | http://www.keio-urology.jp/ | ||||||
| Number of participants that the trial has enrolled | 0 | ||||||
| Results | Not started. |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Not started. |
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| Participant flow | Not started. |
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| Adverse events | Not started. |
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| Outcome measures | Not started. |
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| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Terminated | ||||||
| Date of protocol fixation |
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| Last follow-up date |
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| Date of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| Date analysis concluded | |||||||
| Other | |
| Other related information | Case control sampling and prospective study |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002779 |
