UMIN-CTR Clinical Trial

Basic information
Public title	An ancillary study of "a randomized phase 2 study of TS-1 versus CDDP+VNR for adjuvant therapy in patients with non-small cell lung cancer(UMIN000027435)" - investigation of effect prediction bio-marker for adjuvant therapy.
Acronym	LOGIK1702-A
Scientific Title	An ancillary study of "a randomized phase 2 study of TS-1 versus CDDP+VNR for adjuvant therapy in patients with non-small cell lung cancer(UMIN000027435)" - investigation of effect prediction bio-marker for adjuvant therapy.
Scientific Title:Acronym	LOGIK1702-A
Region	Japan

Condition
Condition	Non-small-cell lung cancer
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We investigate prognostic factor and effect prediction factor for chemotherapy in patients who enrolled in LOGIK1702(UMIN000027435)study entitled "a randomized phase 2 study of TS-1 versus CDDP+VNR for adjuvant therapy in patients with non-small cell lung cancer".
Basic objectives2	Others
Basic objectives -Others	/Protein expression analysis using immunohistochemical staining /Gene mutation analysis of tumor tissue specimen /Gene polymorphism analysis of tumor tissue specimen
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	/Protein expression analysis using immunohistochemical staining /Gene mutation analysis of tumor tissue specimen /Gene polymorphism analysis of tumor tissue specimen
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients enrolled in LOGIK1702 2) Patients providing the written informed consent.
Key exclusion criteria	Nothing particular
Target sample size	190

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Nagayasu
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Division of Surgical Oncology,
Zip code	852-8501
Address	1-7-1 Sakamoto,Nagasaki,Nagasaki 852-8501,Japan
TEL	095-819-7304
Email	nagayasu@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Tomoshi Middle name Last name Tsuchiya
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Division of Surgical Oncology,
Zip code	852-8501
Address	1-7-1 Sakamoto,Nagasaki,Nagasaki 852-8501,Japan
TEL	095-819-7304
Homepage URL
Email	tomoshi@nagasaki-u.ac.jp

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	1) Lung Oncology Group in Kyushu (LOGIK)
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagasaki University Hospital Clinical Research Ethics Committee
Address	1-7-1 Sakamoto,Nagasaki,Nagasaki 852-8501,Japan
Tel	095-819-7905
Email	gaibushikin@ml.nagasaki-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	長崎大学病院（長崎県）

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 22 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	Terminated
Date of protocol fixation	2017 Year 05 Month 02 Day
Date of IRB	2017 Year 05 Month 16 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date	2027 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Paraffin embedded specimen from a portion including cancer of surgery sample. Protein expression analysis using immunohistochemical staining:TS(thymidylate synthase),DPD(dihydropyrimidine dehydrogenase),UMPS/OPRT(uridine monophosphate synthase/orotate phosphoribosyl transferase),TP(thymidine phosphorylase),ERCC1(excision repair cross-complementing rodent repair deficiency-1),Class III Beta-tubulin Gene polymorphism analysis:single nucleotide polymorphism,SNP538(G>A) in ABCC11/MRP8(multidrug resistance-associated protein 8,ABCC11) Gene mutation analysis:EGFR(epidermal growth factor receptor)

Management information
Registered date	2017 Year 05 Month 22 Day
Last modified on	2022 Year 05 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031435