UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035419
Receipt number R000040353
Scientific Title Prospective study using cancer registry in Japan on prognosis of patients with early esophageal cancer after curative endoscopic resection
Date of disclosure of the study information 2018/12/31
Last modified on 2018/12/31 16:53:32

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information

Public title

Prospective study using cancer registry in Japan on prognosis of patients with early esophageal cancer after curative endoscopic resection

Acronym

Prospective study using cancer registry in Japan on prognosis of patients with early esophageal cancer after curative endoscopic resection

Scientific Title

Prospective study using cancer registry in Japan on prognosis of patients with early esophageal cancer after curative endoscopic resection

Scientific Title:Acronym

Prospective study using cancer registry in Japan on prognosis of patients with early esophageal cancer after curative endoscopic resection

Region

Japan


Condition

Condition

esophageal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the cause of death
(Especially cause of death from other diseases)

Basic objectives2

Others

Basic objectives -Others

Risk factors for poor prognosis cases
(Particularly the morbidity of other cancers)

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The cause of death of patients with esophageal cancer after curative resection endoscopically

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 early esophageal cancer after endoscopic resection who had been proved curative excision histologically and had survived at least 1 year after resection

Key exclusion criteria

1. The depth reaching submucosa below 200 micro-meter.
2. Excision deep end stump is positive.
3. CT, ultrasound endoscopic examination recognizes lesions suspected of lymph node metastasis.
4. Death cases within 1 year after endoscopic treatment (regardless of cause of death)

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichiro Kawaguchi

Organization

Tottori University

Division name

Division of Medicine and Clinical Science

Zip code


Address

36-1 Nishi-cho, Yonago City, Tottori, 683-8504 Japan

TEL

0859-38-6527

Email

koichiro@med.tottori-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koichiro Kawaguchi

Organization

Tottori University

Division name

Division of Medicine and Clinical Science

Zip code


Address

36-1 Nishi-cho, Yonago City, Tottori, 683-8504 Japan

TEL

0859-38-6527

Homepage URL


Email

koichiro@med.tottori-u.ac.jp


Sponsor or person

Institute

Tottori University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

鳥取大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 31 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

Enrolling by invitation

Date of protocol fixation

2018 Year 01 Month 14 Day

Date of IRB


Anticipated trial start date

2018 Year 04 Month 18 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Extract follow-up endoscopes, blood collection data, clinical information annually from patients who survived for 1 year after endoscopic therapy. Ultimately, it is an observational study that carries out a prognostic survey using cancer registration.


Management information

Registered date

2018 Year 12 Month 31 Day

Last modified on

2018 Year 12 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040353


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name