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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005553
Receipt No. R000006469
Scientific Title The study for clinical usefulness of the cross-linked N-telopeptide of type I collagen as a marker of bone metastasis from lung cancer
Date of disclosure of the study information 2011/05/04
Last modified on 2013/03/18

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Basic information
Public title The study for clinical usefulness of the cross-linked N-telopeptide of type I collagen as a marker of bone metastasis from lung cancer
Acronym The study for clinical usefulness of the NTx as a marker from lung cancer
Scientific Title The study for clinical usefulness of the cross-linked N-telopeptide of type I collagen as a marker of bone metastasis from lung cancer
Scientific Title:Acronym The study for clinical usefulness of the NTx as a marker from lung cancer
Region
Japan

Condition
Condition lung cancer, breast cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Usefulness of the serum cross-linked N-telopeptide of type I collagen as a marker of bone metastasis from lung and breast cancer
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1:Severrity of symptoms of bone metastasis in bone scintigraphy and comparative study of NTx
2-1:Utility examination of NTX in monitor of therapeutic gain after bone metastasis is diagnosed and bone metastasis progress level
2-2:Utility of bone metastasis index
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 1:Severrity of symptoms of bone metastasis in bone scintigraphy and comparative study of NTx
2-1:Utility examination of NTX in monitor of therapeutic gain after bone metastasis is diagnosed and bone metastasis progress level
2-2:Utility of bone metastasis index
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 lung cancer,breast cancer
no malignancy with benign lesion in lung cancer
Key exclusion criteria 1:Patient who judged that research representative or allotment researcher is improper
2:Bisphosphonate administering patient
3:Metabolic bone disease patient
4:Kidney function deterioration patient
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonori Hirashima
Organization Osaka prefectural Medical Center for Respiratory and Allergic Diseases
Division name Thoracic Malignancy
Zip code
Address 3-7-1 Habikino Habikino city Osaka Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Motohiro Tamiya
Organization Osaka prefectural Medical Center for Respiratory and Allergic Diseases
Division name Thoracic Malignancy
Zip code
Address
TEL
Homepage URL
Email moto19781205@yahoo.co.jp

Sponsor
Institute Osaka prefectural Medical Center for Respiratory and Allergic Diseases
Institute
Department

Funding Source
Organization Alere Medical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka city general hospital
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
2011 Year 05 Month 04 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
2010 Year 02 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 05 Month 04 Day
Last modified on
2013 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006469

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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