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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043080
Receipt No. R000049182
Scientific Title Liquid biopsy research to identify tumor GEnomic profiling of recurrent gastric or gastroesophageal junction cancer by Analyzing circulating tumoR DNA:Liquid-GEAR trial
Date of disclosure of the study information 2021/01/21
Last modified on 2021/01/21

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Basic information
Public title A liquid biopsy study of recurrent gastric/gastroesophageal junction cancer
Acronym Liquid-GEAR trial
Scientific Title Liquid biopsy research to identify tumor GEnomic profiling of recurrent gastric or gastroesophageal junction cancer by Analyzing circulating tumoR DNA:Liquid-GEAR trial
Scientific Title:Acronym Liquid-GEAR trial
Region
Japan

Condition
Condition gastric or gastroesophageal junction cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To reveal the molecular biological characteristics of recurrent gastric cancer/gastroesophageal junction cancer by using ctDNA to identify the genetic alterations targeted for therapy in patients with recurrent gastric cancer/gastroesophageal junction cancer and compare them with the genetic profile of the primary tumor.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The detection rate of therapeutic target genetic alterations in ctDNA
Key secondary outcomes The genetic profiles detected by ctDNA
The genetic profile obtained by gene panel test using primary tumor tissue.
Time from resection of the primary tumor to detection of recurrence.
Progression-free survival and response rate for each treatment.
Overall survival from the initiation of first-line chemotherapy.

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 (1) Age 20 years or older at the time of obtaining consent.
(2) Patients must have gastric cancer or gastroesophageal junction cancer pathologically diagnosed as adenocarcinoma.
(3) The patient has been diagnosed as Stage II or Stage III (Cancer Treatment Code, 15th Edition) and has received adjuvant chemotherapy after radical resection.
(3) The patient has been diagnosed as Stage II or Stage III (cancer treatment code, 15th edition) and has received adjuvant chemotherapy after radical resection.
(4) The patient has been diagnosed with gastric cancer recurrence by imaging examination and is scheduled to receive anticancer drug therapy for the recurrent lesion.
(5) Tumor tissue from the primary tumor site is available for gene panel testing.
(6) Written consent has been obtained.
Key exclusion criteria (1) Has other malignancy (excluding intraepithelial cancer) within 2 years.
(2) The patient is not expected to survive for more than 12 weeks.
(3) The principal investigator judges that participation in this study is inappropriate.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yu
Middle name
Last name Sunakawa
Organization St.Marianna University School of Medicine
Division name Clinical Oncology
Zip code 2168511
Address Sugao 2-16-1, Miyamae, Kawasaki, Kanagawa
TEL 044-977-8111
Email y.sunakawa@marianna-u.ac.jp

Public contact
Name of contact person
1st name Hiroyuki
Middle name
Last name Takeda
Organization St.Marianna University School of Medicine
Division name Clinical Oncology
Zip code 2168511
Address Sugao 2-16-1, Miyamae, Kawasaki, Kanagawa
TEL 044-977-8111
Homepage URL
Email hiroyuki.takeda@marianna-u.ac.jp

Sponsor
Institute St.Marianna University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization St.Marianna University School of Medicine
Address Sugao 2-16-1, Miyamae, Kawasaki, Kanagawa
Tel 044-977-8111
Email hiroyuki.takeda@marianna-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
2021 Year 01 Month 21 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 Open public recruiting
Date of protocol fixation
2020 Year 11 Month 02 Day
Date of IRB
2021 Year 01 Month 21 Day
Anticipated trial start date
2021 Year 01 Month 21 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To compare with the genetic profile of the tissue of the surgically resected primary tumor, the results of gene panel tests performed on the surgical tissue will be collected and compared with ctDNA.
In order to search for biomarkers related to prognosis and treatment response, information on the patient background and the clinical course will be collected, and the association between these clinical data and genetic changes will be analyzed.

Management information
Registered date
2021 Year 01 Month 21 Day
Last modified on
2021 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049182

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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