UMIN-CTR Clinical Trial

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
Email	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
Email	kuboa@aichi-med-u.ac.jp

Sponsor
Institute	Division of Respiratory Medicine and Allergology, Aichi Medical University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043124