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 2023/01/24 20:05:49

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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

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 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

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

No longer 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

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 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

2023 Year 01 Month 24 Day



Link to view the page

Value
https://center6.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