UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037822 |
|---|---|
| Receipt number | R000043124 |
| Scientific Title | Genome-wide analysis of advanced lung cancer cases that showed marked response to chemotherapy resulting in a treatment-free long-term remission |
| Date of disclosure of the study information | 2019/08/28 |
| Last modified on | 2021/02/28 16:21:53 |
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Basic information
Public title
Genome-wide analysis of advanced lung cancer cases that showed marked response to chemotherapy resulting in a treatment-free long-term remission
Acronym
Genome-wide analysis of advanced lung cancer cases that showed marked response to chemotherapy resulting in a treatment-free long-term remission
Scientific Title
Genome-wide analysis of advanced lung cancer cases that showed marked response to chemotherapy resulting in a treatment-free long-term remission
Scientific Title:Acronym
Genome-wide analysis of advanced lung cancer cases that showed marked response to chemotherapy resulting in a treatment-free long-term remission
Region
| Japan |
Condition
Condition
Lung cancer, Mesothelioma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To determine the molecular profile of advanced lung cancer cases that showed marked response to chemotherapy resulting in a treatment-free long-term remission
Basic objectives2
Others
Basic objectives -Others
Somatic gene alterations in the whole exome of tumor tissues
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exploratory assessment of somatic alterations in advanced lung cancer related to marked response to chemotherapy and treatment-free long-term remission
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Stage IV lung cancer or mesothelioma with pathological confirmation
2. Age 20 or older
3. Lung cancer or mesothelioma in remission (complete remission or partial remission) that is achieved by chemotherapy and maintained without any cancer treatment for 2 years or longer after the last dose of chemotherapy
4. Available tumor tissue before chemotherapy for DNA and protein analysis
5. Available peripheral blood sample for DNA extraction as a non-cancerous reference
6. Written informed consent
Key exclusion criteria
1. Active double cancer (patients with treatment-free and disease-free state for 3 years or longer after a curative treatment are eligible)
2. Unsuitable to enter this study judged by an attending physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | AKIHITO |
| Middle name | |
| Last name | KUBO |
Organization
Aichi Medical University School of Medicine
Division name
Division of Respiratory Medicine and Allergology
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
81-561-62-3311
kuboa@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | AKIHITO |
| Middle name | |
| Last name | KUBO |
Organization
Aichi Medical University School of Medicine
Division name
Division of Respiratory Medicine and Allergology
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
81-561-62-3311
Homepage URL
kuboa@aichi-med-u.ac.jp
Sponsor or person
Institute
Division of Respiratory Medicine and Allergology, Aichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University School of Medicine
Address
1-1 Yazakokarimata, Nagakute, Aichi
Tel
0561623311
sec2128@mail.aichi-med-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
愛知医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2019 | 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
4
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No particular related information
Management information
Registered date
| 2019 | Year | 08 | Month | 27 | Day |
Last modified on
| 2021 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043124
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
