UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036884
Receipt number R000042031
Scientific Title Exploratory analysis of biomarkers predicting the treatment response and the prognosis in patients with esophageal carcinoma
Date of disclosure of the study information 2019/05/30
Last modified on 2019/05/29 16:36:10

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Basic information

Public title

Exploratory analysis of biomarkers predicting the treatment response and the prognosis in patients with esophageal carcinoma

Acronym

Analysis of biomarkers predicting the treatment response and the prognosis in esophageal cancer

Scientific Title

Exploratory analysis of biomarkers predicting the treatment response and the prognosis in patients with esophageal carcinoma

Scientific Title:Acronym

Analysis of biomarkers predicting the treatment response and the prognosis in esophageal cancer

Region

Japan


Condition

Condition

Esophageal cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Identification of factors involved in the treatment response or the prognosis by investigating the treatment results and survival in patients with esophageal cancer

Basic objectives2

Others

Basic objectives -Others

Basic research

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Identification of factors involved in the the treatment response or the prognosis

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients with esophageal cancer confirmed by histological examination

Key exclusion criteria

metastatic esophageal tumor

Target sample size

250


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Ohnuma

Organization

Sapporo Medical University School of Medicine

Division name

Department of Medical Oncology

Zip code

060-8543

Address

S-1,W-16, Chuo-ku, Sapporo

TEL

011-611-2111

Email

ohnuma@sapmed.ac.jp


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Ohnuma

Organization

Sapporo Medical University School of Medicine

Division name

Department of Medical Oncology

Zip code

060-8543

Address

S-1,W-16, Chuo-ku, Sapporo

TEL

011-611-2111

Homepage URL


Email

ohnuma@sapmed.ac.jp


Sponsor or person

Institute

Department of Medical Oncology, Sapporo Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Medical Oncology, Sapporo Medical University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Sapporo Medical University

Address

S-1,W-16, Chuo-ku, Sapporo

Tel

011-611-2111

Email

ji-rskk@sapmed.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



Other administrative information

Date of disclosure of the study information

2019 Year 05 Month 30 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

Open public recruiting

Date of protocol fixation

2019 Year 05 Month 16 Day

Date of IRB

2019 Year 05 Month 16 Day

Anticipated trial start date

2019 Year 05 Month 16 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Identification of factors involved in the treatment response or the prognosis by investigating the treatment results and survival in patients with esophageal cancer


Management information

Registered date

2019 Year 05 Month 29 Day

Last modified on

2019 Year 05 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042031


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name