UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027436 |
|---|---|
| Receipt number | R000031435 |
| 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. |
| Date of disclosure of the study information | 2017/05/22 |
| Last modified on | 2022/05/25 10:20:40 |
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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
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
tomoshi@nagasaki-u.ac.jp
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031435
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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