UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040551 |
|---|---|
| Receipt number | R000046280 |
| Scientific Title | Analysis of TCR repertoire for esophageal cancer and rectal cancer after neoadjuvant chemoradiation therapy |
| Date of disclosure of the study information | 2020/05/27 |
| Last modified on | 2022/12/12 14:56:12 |
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Basic information
Public title
Analysis of TCR repertoire for esophageal cancer and rectal cancer after neoadjuvant chemoradiation therapy
Acronym
Analysis of TCR repertoire for esophageal cancer and rectal cancer after neoadjuvant chemoradiation therapy
Scientific Title
Analysis of TCR repertoire for esophageal cancer and rectal cancer after neoadjuvant chemoradiation therapy
Scientific Title:Acronym
Analysis of TCR repertoire for esophageal cancer and rectal cancer after neoadjuvant chemoradiation therapy
Region
| Japan |
Condition
Condition
esophageal cancer and rectal cancer
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this research is to find out predictive markers for chen-radiation therapy for esophageal cancer or rectal cancer by analyzing TCR repertoire, SNPs as well as biological factors relating to immune response for tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TCR repertoire, SNPs as well as biological factors relating to immune response for tumors
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
patients with esophageal cancer or rectal cancer for standard neoadjuvant chemoradiation
Key exclusion criteria
patients who do not give written informed consents
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Mori |
Organization
National Hospital Organization National Sagamihara Hospital
Division name
Department of Clinical Oncology
Zip code
252-0392
Address
18-1 Sakuradai, Minamki-ku Sagamihara-city
TEL
+81-42-742-8311
westendc7m@gmail.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Mori |
Organization
National Hospital Organization National Sagamihara Hospital
Division name
Department of Clinical Oncology
Zip code
252-0392
Address
18-1 Sakuradai, Minamki-ku Sagamihara-city
TEL
+81-42-742-8311
Homepage URL
westendc7m@gmail.com
Sponsor or person
Institute
National Hospital Organization National Sagamihara Hospital
Institute
Department
Personal name
Funding Source
Organization
Repertoire Genesis
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization National Sagamihara Hospital
Address
18-1 Sakuradai, Minamki-ku Sagamihara-city
Tel
+81-42-742-8311
westendc7m@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Int. J. Mol. Sci. 2021, 22, 1098. https://doi.org/10.3390/ijms22031098
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 01 | Month | 22 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study includes collaboration with TohokuUniversity, Kyoto University and National Center for Global Health and Medicine.
Management information
Registered date
| 2020 | Year | 05 | Month | 27 | Day |
Last modified on
| 2022 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046280
