UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018538 |
|---|---|
| Receipt number | R000021453 |
| Scientific Title | Patient survey regarding pathological re-examination in the course of chemotherapy for advanced and recurrent non-small cell lung cancer |
| Date of disclosure of the study information | 2015/08/04 |
| Last modified on | 2019/09/26 13:28:47 |
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Basic information
Public title
Patient survey regarding pathological re-examination in the course of chemotherapy for advanced and recurrent non-small cell lung cancer
Acronym
Questionnaire survey on re-biopsy in non-small cell lung cancer patients
Scientific Title
Patient survey regarding pathological re-examination in the course of chemotherapy for advanced and recurrent non-small cell lung cancer
Scientific Title:Acronym
Questionnaire survey on re-biopsy in non-small cell lung cancer patients
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessment of possibility for pathological re-examination in the course of chemotherapy for patients with non-small cell lung cancer
Basic objectives2
Others
Basic objectives -Others
Patient survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient survey to give consent for pathological re-examination in treatment course of non-small cell lung cancer
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
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
1) Pathologically confirmed non-small lung cancer
2) Advanced and recurrent non-small cell lung cancer (stage III or IV)
3) Make plan to do chemotherapy
4) Obtain written consent from patient
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Masuda |
Organization
Kitasato University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, JAPAN
TEL
042-778-8111
kokyuki@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Fukui |
Organization
Kitasato University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, JAPAN
TEL
042-778-8111
Homepage URL
kokyuki@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato 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
the Kitasato University Medical Ethics Organization
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, JAPAN
Tel
042-778-7756
rinri@med.kitasato-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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 04 | 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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2015 | Year | 08 | Month | 04 | Day |
Last modified on
| 2019 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021453
