UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005553 |
|---|---|
| Receipt number | 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 18:44:19 |
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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
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
moto19781205@yahoo.co.jp
Sponsor or person
Institute
Osaka prefectural Medical Center for Respiratory and Allergic Diseases
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006469
