UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043080 |
|---|---|
| Receipt number | 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 | 2024/12/13 17:43:47 |
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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.
(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
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
hiroyuki.takeda@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
51
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
| 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
| 2023 | 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 the genomic profile of the primary tumor, genomic panel test results obtained from surgically resected tumor tissues will be collected and analyzed in comparison with ctDNA. Additionally, to explore biomarkers associated with prognosis and treatment efficacy, patient background and clinical course data will be collected, and the relationship between these clinical data and genetic alterations will be analyzed.
Management information
Registered date
| 2021 | Year | 01 | Month | 21 | Day |
Last modified on
| 2024 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049182
