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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034830
Receipt No. R000038705
Official scientific title of the study Prospective observational study to evaluate clinical utility of FoundationObe CDx
Date of disclosure of the study information 2018/11/10
Last modified on 2018/11/09

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Basic information
Official scientific title of the study Prospective observational study to evaluate clinical utility of FoundationObe CDx
Title of the study (Brief title) 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 Manabu Muto
Organization Kyoto University Hospital
Division name Clinical Oncology
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 Tomohiro Kondo
Organization Kyoto University Hospital
Division name Clinical Oncology
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 07 Day
Anticipated trial start date
2018 Year 11 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information observational study

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


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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