UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042408
Receipt No. 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 2020/11/10

* 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 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
Obsterics 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
Institute Kyoto University Hospital
Institute
Department

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

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 11 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 Preinitiation
Date of protocol fixation
2020 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2021 Year 02 Month 01 Day
Last follow-up date
2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2020 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.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


Contact us.