UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033647
Receipt number R000038129
Scientific Title Trial of a multiplex genomic testing by "Todai OncoPanel" for Geneprofiling of malignant solid tumors
Date of disclosure of the study information 2018/08/10
Last modified on 2023/08/10 09:27:44

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Basic information

Public title

Trial of a multiplex genomic testing by "Todai OncoPanel" for Geneprofiling of malignant solid tumors

Acronym

Todai OncoPanel (Advanced Medical Care Category B)

Scientific Title

Trial of a multiplex genomic testing by "Todai OncoPanel" for Geneprofiling of malignant solid tumors

Scientific Title:Acronym

Todai OncoPanel (Advanced Medical Care Category B)

Region

Japan


Condition

Condition

Malignant solid tumors (including both carcinoma and sarcoma)

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To estimate usefulness of a multiplex genomic testing "Todai OncoPanel"

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Ratio of actionable genomic alterations (both therapeutically and diagnostically)

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

1) Pathologically diagnosed as malignant tumors (either carcinoma or sarcoma) (except for hematopoietic malingancies)
2) Considered to be incurable due to unresectable or recurrent condition
3) Already treated by standard therapies
4) Genomic testing is considered to be useful for decision of a therapeutic option
5) Performance Status: 0 or 1
6) Tumor sample is sufficiently available for the testing
7) Written informed consent

Key exclusion criteria

None

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Katsutoshi
Middle name
Last name Oda

Organization

The University of Tokyo Hospital

Division name

Department of Obstetrics and Gynecology

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Email

katsutoshi-tky@umin.ac.jp


Public contact

Name of contact person

1st name Shiori
Middle name
Last name Toyomaru

Organization

The University of Tokyo Hospital

Division name

Medical Research Division

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Homepage URL

http://todaioncopanel.umin.jp/

Email

rinsho@adm.h.u-tokyo.ac.jp


Sponsor or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Reserch and Development

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor

Sysmex CO., LTD., RIKEN GENESIS CO., LTD., Xcoo CO.LTD.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Graduate School and Faculty of Medicine, The University of Tokyo

Address

7-3-1 Hongo, Bunkyoo-ku, Tokyo

Tel

03-3815-5411

Email

ethics@m.u-tokyo.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

2018 Year 08 Month 10 Day


Related information

URL releasing protocol

doi: 10.1111/cas.15717.

Publication of results

Published


Result

URL related to results and publications

doi: 10.1111/cas.15717.

Number of participants that the trial has enrolled

200

Results

One hundred and four samples (53%) harbored gene alterations that were detected with the DNA panel and had potential treatment implications, and 14 samples (7%) had a high tumor mutational burden. Thirteen patients (7%) were found to have pathogenic or likely pathogenic germline variants and genetic counseling was recommended. Overall, 12 patients (6%) received recommended treatment.

Results date posted

2023 Year 08 Month 10 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2023 Year 01 Month 17 Day

Baseline Characteristics

Patients with cancers without standard treatment or when patients had already undergone standard treatment.

Participant flow

Todai OncoPanel (TOP) is a dual DNA-RNA panel as well as a paired tumor-normal matched test. Two hundred patients underwent TOP as part of Advanced Medical Care B with approval from the Ministry of Health, Labour and Welfare between September 2018 and December 2019.

Adverse events

N/A

Outcome measures

Primary endpoint: ratio of patients who harbored 1) and/or 2) findings by Todai OncoPanel.
1) one or more alterations with Tier 1, 2 and R, and/or hypermutator (Tumor Mutational Burden-High)
2) supportive for pathological diagnosis

The ratio was 59.1%.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 07 Month 05 Day

Date of IRB

2018 Year 07 Month 03 Day

Anticipated trial start date

2018 Year 08 Month 29 Day

Last follow-up date

2020 Year 01 Month 31 Day

Date of closure to data entry

2023 Year 08 Month 10 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

Estimated Registration Completion Date: Dec 31, 2019


Management information

Registered date

2018 Year 08 Month 06 Day

Last modified on

2023 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038129


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name