UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study to evaluate clinical utility of FoundationObe CDx
Acronym	Prospective observational study to evaluate clinical utility of FoundationObe CDx
Scientific Title	Prospective observational study to evaluate clinical utility of FoundationObe CDx
Scientific Title:Acronym	Prospective observational study to evaluate clinical utility of FoundationObe CDx
Region	Japan

Condition
Condition	gastrointestinal cancer, rare cancer and cancer of unknown primary
Classification by specialty	Medicine in general
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To determine the rate of actionable/druggable cancer genomic alterations in patients with stage III/IV gastrointestinal cancer, rare cancer and cancer of unknown primary using panel-based genomic sequencing test
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection rate of actionable/druggable cancer genomic alterations using FoundationOne CDx
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients with histologically diagnosed stage III/IV(UICC-TNM 8th)gastrointestinal cancer, rare cancer and cancer of unknown primary 2. Written informed consent 3. Formalin Fixed Paraffin Embedded(FFPE)cancer tissue is available for pathological diagnosis, and remaining cancer tissue is enough for genomic sequencing test as well. 4. Age >= 16 years 5. Previously untreated cancer patients. The following patients will be allowed: patients treated with oral anticancer drugs as adjuvant therapy and patients with sufficient FFPE tissue obtained before the start of anticancer drugs. 6. Patients with recurrent disease inside irradiation field will be excluded. (If tissue is available from a recurrent tumor outside the irradiation field, the patient can be included.) 7. For a recurrence case, it has to be less than 3 years after surgery.
Key exclusion criteria	1. Patients without available tumor tissue 2. Patients judged to be inappropriate for the study by investigators
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Manabu Muto
Organization	Kyoto University Hospital
Division name	Clinical Oncology
Zip code
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL	075-751-3518
Email	fmi_kuhp@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tomohiro Kondo
Organization	Kyoto University Hospital
Division name	Clinical Oncology
Zip code
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL	075-751-3518
Homepage URL
Email	fmi_kuhp@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
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
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

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 10 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	Completed
Date of protocol fixation	2018 Year 11 Month 07 Day
Date of IRB	2018 Year 11 Month 08 Day
Anticipated trial start date	2018 Year 11 Month 12 Day
Last follow-up date	2021 Year 11 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observational study

Management information
Registered date	2018 Year 11 Month 09 Day
Last modified on	2021 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038705