UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042408
Receipt number R000048412
Scientific Title Prospective clinical study of comprehensive genomic profiling for patients with chemotherapy-naive advanced cancer.
Date of disclosure of the study information 2020/11/11
Last modified on 2022/12/13 14:55:29

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Basic information

Public title

Prospective clinical study of comprehensive genomic profiling for patients with chemotherapy-naive advanced cancer.

Acronym

FIRST-Dx trial

Scientific Title

Prospective clinical study of comprehensive genomic profiling for patients with chemotherapy-naive advanced cancer.

Scientific Title:Acronym

FIRST-Dx trial

Region

Japan


Condition

Condition

advanced cancer

Classification by specialty

Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Hematology and clinical oncology Breast surgery
Obstetrics and Gynecology Dermatology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the clinical utility of F1CDx in patients with chemotherapy naive advanced cancer.

Basic objectives2

Others

Basic objectives -Others

Evaluation of clinical utility of F1CDx

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Ratio of cancer patients with actionable genomic alteration

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

Age>20 y.o.
ECOG PS 0-1
Pathologically confirmed malignancy
Cancers in GI tracts, biliary tract, pancreas, lung, breast, gynecologic organs, and skin melanoma.
No prior chemotherapy or radiotherapy.
Tissue available for F1CDx
Written informed consent

Key exclusion criteria

Inappropriate for trial due to mental disease.
Inappropriate for trial judged by medical doctors.

Target sample size

180


Research contact person

Name of lead principal investigator

1st name Manabu
Middle name
Last name Muto

Organization

Kyoto University Hospital

Division name

Department of Clinical Oncology

Zip code

606-8507

Address

54 Shogoinkawahara-cho, Sakyo-ku, Kyoto-shi

TEL

075-751-3111

Email

mmuto@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Junichi
Middle name
Last name Matsubara

Organization

Kyoto University Hospital

Division name

Department of Clinical Oncology

Zip code

606-8507

Address

54 Shogoinkawahara-cho, Sakyo-ku, Kyoto-shi

TEL

075-751-3111

Homepage URL


Email

jmatsuba@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Hospital

Institute

Department

Personal name



Funding Source

Organization

CHUGAI PHARMACEUTICAL CO., LTD.

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

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto-shi

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.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

京都大学医学部附属病院(京都府)、東京大学医学部附属病院(東京都)、東京医科歯科大学医学部附属病院(東京都)、愛知県がんセンター(愛知県)、富山大学附属病院(富山県)、和歌山県立医科大学附属病院(和歌山県)


Other administrative information

Date of disclosure of the study information

2020 Year 11 Month 11 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.mhlw.go.jp/stf/shingi2/0000205617_00052.html

Number of participants that the trial has enrolled

182

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

2020 Year 11 Month 10 Day

Date of IRB

2020 Year 11 Month 30 Day

Anticipated trial start date

2021 Year 05 Month 01 Day

Last follow-up date

2022 Year 07 Month 30 Day

Date of closure to data entry

2022 Year 10 Month 31 Day

Date trial data considered complete

2023 Year 01 Month 31 Day

Date analysis concluded

2023 Year 01 Month 31 Day


Other

Other related information

This observational study will be conducted as an Advanced Medical Care B


Management information

Registered date

2020 Year 11 Month 10 Day

Last modified on

2022 Year 12 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048412


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name