UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031810 |
|---|---|
| Receipt number | R000036325 |
| Scientific Title | Influence of social determinants of health in patients with advanced lung cancer: a prospective cohort study |
| Date of disclosure of the study information | 2018/03/20 |
| Last modified on | 2018/09/19 13:24:36 |
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Basic information
Public title
Influence of social determinants of health in patients with advanced lung cancer: a prospective cohort study
Acronym
Influence of social determinants of health in patients with advanced lung cancer
Scientific Title
Influence of social determinants of health in patients with advanced lung cancer: a prospective cohort study
Scientific Title:Acronym
Influence of social determinants of health in patients with advanced lung cancer
Region
| Japan |
Condition
Condition
advanced lung cancer
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to assess the effects of SDH on patients with advanced lung cancer in Japan
Basic objectives2
Others
Basic objectives -Others
To explore the relationship between exposures and outcomes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
initial treatment
Key secondary outcomes
rout to diagnosis, overall survival, stage of cancer progression and performance status at the time of enrolment, and place of death
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. A pathological or clinical diagnosis of lung cancer
2. Willingness to provide written informed consent for enrolment in the study
3. Unsuitability for curative surgery
4. Previously untreated or within 2 months of starting treatment for newly diagnosed lung cancer.
Key exclusion criteria
1. Inability to complete a study questionnaire because of dementia or mental illness
2. Unsuitable for participation in the study in the opinion of the attending physician.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuki Kataoka |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
2-17-77, Higashi Naniwacho, Amagasaki, Hyogo
TEL
06-6480-7000
hanshin.crt@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Kataoka |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
2-17-77, Higashi Naniwacho, Amagasaki, Hyogo
TEL
06-6480-7000
Homepage URL
hanshin.crt@gmail.com
Sponsor or person
Institute
Hyogo Prefectural Amagasaki General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Hyogo Prefectural Amagasaki General Medical Center
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
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
兵庫県立尼崎総合医療センター
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 20 | 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
| 2018 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The variables evaluated in this study will be social isolation, loneliness, employment, social security income, education, dementia, smoking history, weight loss, respiratory symptoms, tissue type, mutation status (epidermal growth factor receptor, anaplastic lymphoma kinase, ROS1), and programmed death-ligand 1 status.
Social isolation will be surveyed using the Japanese short version of the Lubben Social Network Scale (LSNS-6).Loneliness will be surveyed using the Japanese Version 3 of the UCLA (University of California, Los Angeles) Loneliness Scale.
Management information
Registered date
| 2018 | Year | 03 | Month | 20 | Day |
Last modified on
| 2018 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036325
| 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 |
