UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031045 |
|---|---|
| Receipt number | R000035452 |
| Scientific Title | Immune checkpoint status and oncogenic mutation profiling of rectal cancer after neoadjuvant chemotherapy (KSCC1301-A2). |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2021/08/02 10:51:49 |
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Basic information
Public title
Immune checkpoint status and oncogenic mutation profiling of rectal cancer after neoadjuvant chemotherapy (KSCC1301-A2).
Acronym
Immune checkpoint status and oncogenic mutation profiling of rectal cancer after neoadjuvant chemotherapy (KSCC1301-A2).
Scientific Title
Immune checkpoint status and oncogenic mutation profiling of rectal cancer after neoadjuvant chemotherapy (KSCC1301-A2).
Scientific Title:Acronym
Immune checkpoint status and oncogenic mutation profiling of rectal cancer after neoadjuvant chemotherapy (KSCC1301-A2).
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To find new biomarkers for immune checkpoint inhibitor among rectal cancer patients after neoadjuvant chemotherapy.
Basic objectives2
Others
Basic objectives -Others
Searching for Biomarker
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
PD-L1 expression status among rectal cancer patients after neoadjuvant chemotherapy.
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
KSCC participants
As control arm, 37 rectal cancer patients who underwent surgery at our hospital without neoadjuvant therapy.
Key exclusion criteria
Same as KSCC1301(UMIN000011486)
Target sample size
147
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Oki |
Organization
Kyushu University Hospital
Division name
Department of Surgery and Science
Zip code
812-8582
Address
812-8582 3-1-1 Maidashi, Higashi-Ku, Fukuoka-shi, Japan
TEL
092-642-5466
okieiji@surg2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Miyashita |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Science
Zip code
812-8582
Address
812-8582 3-1-1 Maidashi, Higashi-Ku, Fukuoka-shi, Japan
TEL
092-642-5466
Homepage URL
miya_y@surg2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu Study group of Clinical Cancer
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Ethics Review Committee
Address
812-8582 3-1-1 Maidashi, Higashi-Ku, Fukuoka-shi, Japan
Tel
092-641-1151
byssien@jimu.kyushu-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
九州大学病院（福岡県）
東京医科大学病院（東京都）
獨協医科大学病院（栃木県）
久留米大学病院（福岡県）
兵庫県立がんセンター（兵庫県）
鹿児島大学病院（鹿児島県）
名古屋大学病院（愛知県）
福岡市民病院（福岡県）
長崎大学病院 腫瘍外科/移植・消化器外科（長崎県）
鹿児島厚生連病院（鹿児島県）
北播磨総合医療センター（兵庫県）
済生会唐津病院（佐賀県）
東邦大学医療センター大森病院（東京都）
JCHO人吉医療センター（熊本県）
熊本大学医学部附属病院（熊本県）
国立病院機構九州医療センター（福岡県）
医理会柿添病院（長崎県）
大分大学医学部附属病院（大分県）
飯塚病院（福岡県）
岡山労災病院（岡山県）
九州大学病院別府病院（大分県）
聖マリアンナ医科大学病院（神奈川県）
佐世保市立総合病院（長崎県）
愛知県がんセンター愛知病院（愛知県）
国立病院機構大分医療センター（大分県）
済生会川内病院（鹿児島県）
熊本地域医療センター（熊本県）
伊万里有田共立病院（佐賀県）
田川市立病院（福岡県）
社会保険田川病院（福岡県）
国立病院機構名古屋医療センター（愛知県）
神戸市立医療センター中央市民病院（兵庫県）
浦添総合病院（沖縄県）
松山赤十字病院（愛媛県）
福井県済生会病院（福井県）
天草地域医療センター（熊本県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 01 | 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
147
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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Review the immunohistochemical results of each case registered in this study.
Management information
Registered date
| 2018 | Year | 01 | Month | 29 | Day |
Last modified on
| 2021 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035452
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
