UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041595 |
|---|---|
| Receipt number | R000047480 |
| Scientific Title | Exploratory research of molecules contained in exosomes secreted from lung cancer |
| Date of disclosure of the study information | 2020/08/28 |
| Last modified on | 2020/08/28 15:26:29 |
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Basic information
Public title
Exploratory research of molecules contained in exosomes secreted from lung cancer
Acronym
Analysis of exosomes in lung cancer
Scientific Title
Exploratory research of molecules contained in exosomes secreted from lung cancer
Scientific Title:Acronym
Analysis of exosomes in lung cancer
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To find new markers for treatment of lung cancer by analyzing exosomes.
Basic objectives2
Others
Basic objectives -Others
To research whether or not exosomes can be markers for treatment index of lung cancer.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Search of molecular markers in lung cancer specific exosomes.
Key secondary outcomes
Correlation with postoperative recurrence and exosomes.
Correlation with therapeutic effect in postoperative recurrence and exosomes.
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
A person falling under any of the following;
(i) Patients who will undergo radical surgery for lung cancer and were confirmed lung cancer in pathological diagnosis.
(ii) Patients with recurrence after undergoing radical surgery for lung cancer.
(iii) Patients with progressive disease treated alone or with combination of chemotherapy, radiation therapy and immunotherapy after undergoing radical surgery for lung cancer.
(iv) Healthy person with no history of diagnosis or treatment of malignant tumors
Key exclusion criteria
A person falling under any of the following;
(i) Patients who are diagnosed not to have lung cancer in postoperative pathologic diagnosis although patients were registered by key inclusion criteria (i).
(ii) Patients who are determined to be ineligible as human research subjects by researchers.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Kimikazu |
| Middle name | |
| Last name | Hamano |
Organization
Yamaguchi University
Division name
Department of Surgery and Clinical Science
Zip code
7558505
Address
1-1-1, Minami-kogushi, ube, Japan
TEL
0836-22-2261
cres-sg1@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Murakami |
Organization
Yamaguchi University
Division name
Department of Surgery and Clinical Science
Zip code
7558505
Address
1-1-1, Minami-kogushi, ube, Japan
TEL
0836-22-2261
Homepage URL
cres-sg1@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Center for Clinical Research, Yamaguchi University Hospital
Address
1-1-1, Minami-kogushi, ube, Japan
Tel
0836-22-2428
me223@yamaguchi-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
| 2020 | Year | 08 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Background of human research subject
2. Surgery related factors
3. Pathological factors
4. Post-operative factor
5. Analysis items in this research
Management information
Registered date
| 2020 | Year | 08 | Month | 28 | Day |
Last modified on
| 2020 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047480
| 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 |
