UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011591
Receipt number R000013552
Scientific Title The role of procalcitonin (PCT) in advanced urological cancer patients with high grade fever
Date of disclosure of the study information 2013/08/28
Last modified on 2022/09/03 13:47:30

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Basic information

Public title

The role of procalcitonin (PCT) in advanced urological cancer patients with high grade fever

Acronym

PCT in advanced urological cancer patients

Scientific Title

The role of procalcitonin (PCT) in advanced urological cancer patients with high grade fever

Scientific Title:Acronym

PCT in advanced urological cancer patients

Region

Japan


Condition

Condition

advanced urological cancer

Classification by specialty

Hematology and clinical oncology Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Differential diagnosis between bacterial infection and neoplastic fever in patients with advanced urological cancer

Basic objectives2

Others

Basic objectives -Others

Diagnostic value

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

comparison of the rate of bacterial infection between defferent PCT levels

Key secondary outcomes

the relation between the rate of bacterial infection and other factors such as primary tumor, age, white blood cell count, CRP, body temparature


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

metastatic, locally invasive, or large (longest diameter >5cm, or total of longest diameter >5cm in multiple lesions) urological cancer including urothelial cancer, renal cell cancer, germ cell cancer, prostate cancer, penile cancer, and cancer or sarcoma arisen in genitourinary systems)

Key exclusion criteria

patients who did not agree with this study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kouji
Middle name
Last name Izumi

Organization

Kanazawa University Graduate School of Medical Science

Division name

Department of Integrative Cancer Therapy and Urology

Zip code

9208641

Address

13-1 Takaramachi, Kanazawa, Japan

TEL

076-265-2393

Email

azuizu2003@yahoo.co.jp


Public contact

Name of contact person

1st name Kouji
Middle name
Last name Izumi

Organization

Kanazawa University Graduate School of Medical Science

Division name

Department of Integrative Cancer Therapy and Urology

Zip code

9208641

Address

13-1 Takaramachi, Kanazawa, Japan

TEL

076-265-2393

Homepage URL


Email

azuizu2003@yahoo.co.jp


Sponsor or person

Institute

Kanazawa University Graduate School of Medical Science, Department of Integrative Cancer Therapy and Urology

Institute

Department

Personal name



Funding Source

Organization

Kanazawa University Graduate School of Medical Science, Department of Integrative Cancer Therapy and Urology

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

Institutional review board

Address

13-1 Takaramachi Kanazawa Japan

Tel

076-265-2103

Email

rinri@med.kanazawa-u.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

石川県立中央病院(石川県)、国立病院機構金沢医療センター(石川県)、富山県立中央病院(富山県)、厚生連高岡病院(富山県)、敦賀市立病院(福井県)、福井済生会病院(福井県)


Other administrative information

Date of disclosure of the study information

2013 Year 08 Month 28 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

106

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

2013 Year 07 Month 17 Day

Date of IRB

2013 Year 07 Month 17 Day

Anticipated trial start date

2013 Year 08 Month 28 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

PCT, CRP, white blood cell, red blood cell, platelet cell, Hb, BUN, Cr, AST, ALT, LDH, AFP, Total protein, albmin, and cultures(sputum, urin, stool), radiological diagnostic modalities (X-ray, CT, MRI, Ga scintigraphy, ultrasound) if needed.


Management information

Registered date

2013 Year 08 Month 27 Day

Last modified on

2022 Year 09 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013552


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name