UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034830
Receipt number R000038705
Scientific Title Prospective observational study to evaluate clinical utility of FoundationObe CDx
Date of disclosure of the study information 2018/11/10
Last modified on 2021/05/12 09:02:06

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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 or person

Institute

Kyoto University

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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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