UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018538
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kokyuki@kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021453

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.