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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name