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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000034394
Receipt No. R000039210
Scientific Title Circulating Tumor DNA Sequencing Study for Rare Cancers: an Ancillary Research Study to the MASTER KEY Registry Study (NCCH1612)
Date of disclosure of the study information 2018/10/22
Last modified on 2019/05/08

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Basic information
Public title Circulating Tumor DNA Sequencing Study for Rare Cancers: an Ancillary Research Study to the MASTER KEY Registry Study (NCCH1612)
Acronym Circulating Tumor DNA Sequencing Study for Rare Cancers
Scientific Title Circulating Tumor DNA Sequencing Study for Rare Cancers: an Ancillary Research Study to the MASTER KEY Registry Study (NCCH1612)
Scientific Title:Acronym Circulating Tumor DNA Sequencing Study for Rare Cancers
Region
Japan

Condition
Condition Rare cancers, Rare hisotogical subtypes of major cancers, Carcinoma of unknown primary
Classification by specialty
Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 1) To analyze the types and incidence of genetic alterations in rare cancer (solid tumor) patients using circulating tumor DNA (ctDNA) next generation sequencing (NGS) analysis.
2) To analyze the cancer specific gene alterations, treatment details according to each gene alteration, treatment outcome, etc., by integrating the MASTER KEY Registry study (NCCH1612) clinicopathological data and the genetic information gained from this research study.
Basic objectives2 Others
Basic objectives -Others Analyze the clinical utility of Guardant360 gene panel for ctDNA in rare cancers.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1) Overall incidence of any genetic alterations(analyzed in all rare cancer patients cohort and in each histopathlological subgroup cohort)
2) Incidence of individual genetic alteration(analyzed in all rare cancer patients cohort and in each histopathlological subgroup cohort)
Key secondary outcomes To investigate the congruence of the reported gene alterations from this research study and tissue-based NGS from prior tests, treatment patterns according to each gene alteration, response to treatment, etc.

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 aged 16 years or older at registration.
2) Patients who meet the eligible criteria for the MASTER KEY Registry study (NCCH1612) and have provided a written consent to the MASTER KEY Registry study (NCCH1612). (Enrollment into the MASTER KEY Registry study (NCCH1612) must be done before enrollment into this research study.
3) Patients who provided a written consent to participate in the study (for patients less than 20 years of age, their legally acceptable representative must give consent). For patients who have a will to consent but are physically unable to provide a signature, an allograph by a relative is applicable.
Key exclusion criteria none
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yasuhiro
Middle name
Last name Fujiwara
Organization National Cancer Center Hospital
Division name Department of Breast and Medical Oncology
Zip code 113-0033
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL 03-3542-2511
Email yfujiwar@ncc.go.jp

Public contact
Name of contact person
1st name Hitomi
Middle name
Last name Okuma
Organization National Cancer Center Hospital
Division name Clinical Trial Management Section, Research Management Division/Department of Breast and Medical Onc
Zip code 113-0033
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL 03-3542-2511
Homepage URL
Email hsumiyos@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization Medical Affairs Japan/Asia
Guardant Health Inc
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization USA

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cancer Center Institutional Review Board
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
Tel 03-3542-2511
Email NCC_IRBoffice@ml.res.ncc.go.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 国立がん研究センター中央病院

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 22 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 Suspended
Date of protocol fixation
2018 Year 09 Month 21 Day
Date of IRB
2018 Year 10 Month 25 Day
Anticipated trial start date
2018 Year 11 Month 05 Day
Last follow-up date
2019 Year 11 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Blood samples from rare cancer patients will be collected and tested by Guardant Health, Inc. gene panel to analyse the types and incidence of genetic alterations in rare cancer (solid tumor) patients. The genetic alteration results will also be integrated with the MASTER KEY Registry study (NCCH1612) clinicopathological data to further analyze the cancer specific gene alteration rate, etc.

Management information
Registered date
2018 Year 10 Month 05 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039210

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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