UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038228 |
|---|---|
| Receipt number | R000043017 |
| Scientific Title | Evaluation of serum nestin levels for diagnosis and disease activity in lung cancer patients |
| Date of disclosure of the study information | 2019/10/17 |
| Last modified on | 2023/04/10 18:48:10 |
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Basic information
Public title
Evaluation of serum nestin levels for diagnosis and disease activity in lung cancer patients
Acronym
Evaluation of nestin in lung cancer
Scientific Title
Evaluation of serum nestin levels for diagnosis and disease activity in lung cancer patients
Scientific Title:Acronym
Evaluation of nestin in lung cancer
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the diagnostic usefulness of serum nestin levels in patients with lung cancer. Especially for patients with small cell lung cancer, serum nestin is measured over time to evaluate the relationship between treatment response and prognosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between serum nestin level and disease activigy in small cell lung cacner patients.
Key secondary outcomes
Evaluation of diagnostic significance of serum nestin level at the time of lung cancer diagnosis. Relationship between serum nestin levels and therapeutic response in small cell lung cancer.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with lung cacner at Nagoya City University Hospital.
Patients with obtaining written informed consent.
Key exclusion criteria
Pregnant women and women with the possibility of pregnancy.
Patients with other malignant tumors.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Maeno |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
0528538216
k.maeno@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Maeno |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Respiratory Medicine, Allergy and Clinical Immunology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
0528538216
Homepage URL
k.maeno@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Graduate School of Medical Sciences
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Tel
0528538216
k.maeno@med.nagoya-cu.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
| 2019 | Year | 10 | Month | 17 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
No paticular related information
Management information
Registered date
| 2019 | Year | 10 | Month | 07 | Day |
Last modified on
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043017
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
