UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037918
Receipt number R000043220
Scientific Title Retrospective study of focal radiotherapy for pleural dissemination of thymic tumors
Date of disclosure of the study information 2019/09/05
Last modified on 2021/06/14 22:44:53

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Basic information

Public title

Retrospective study of focal radiotherapy for pleural dissemination of thymic tumors

Acronym

Focal radiotherapy for pleural dissemination of thymic tumors

Scientific Title

Retrospective study of focal radiotherapy for pleural dissemination of thymic tumors

Scientific Title:Acronym

Focal radiotherapy for pleural dissemination of thymic tumors

Region

Japan


Condition

Condition

Thymic tumors

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This study aims to investigate the usefulness of radiotherapy in patients who had local pleural dissemination of thymoma

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival after radiation therapy

Key secondary outcomes

local control rate, progression-free survival rate


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

The patients who had been clinically or histologically diagnosed with recurrent pleural dissemination of thymoma and received radiation therapy in our institution between January 2004 and June 2019.

Key exclusion criteria

1)Having a history of chemotherapy or radiation therapy in the past with different carcinomas
2)Having serious complications
3)Having active double cancer
4)Pregnant or possibly pregnant
5)Under 20-year-old
6)Palliative care

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Dai
Middle name
Last name Okazaki

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Radiology

Zip code

467-8601

Address

1 Kawasumi, Mizuho-cho, Mizuoho-ku, Nagoya-shi,Aichi, Japan

TEL

052-853-8276

Email

g-u1016@hotmail.co.jp


Public contact

Name of contact person

1st name Dai
Middle name
Last name Okazaki

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Radiology

Zip code

467-8601

Address

1 Kawasumi, Mizuho-cho, Mizuoho-ku, Nagoya-shi,Aichi, Japan

TEL

052-853-8276

Homepage URL


Email

g-u1016@hotmail.co.jp


Sponsor or person

Institute

Department of Radiology, Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Clinical Research Management Center, Nagoya City University Hospital

Address

1 Kawasumi, Mizuho-cho, Mizuoho-ku, Nagoya-shi,Aichi, Japan

Tel

052-858-7215

Email

clinical_research@med.nagoya-cu.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 09 Month 05 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


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


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 09 Month 04 Day

Date of IRB

2019 Year 10 Month 03 Day

Anticipated trial start date

2019 Year 09 Month 04 Day

Last follow-up date

2020 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observative analysis of Radiation Therapy


Management information

Registered date

2019 Year 09 Month 04 Day

Last modified on

2021 Year 06 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043220


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name