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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044167
Receipt No. R000050436
Scientific Title Feasibility study of CT colonography for peritoneal metastasis of gastric cancer clinically difficult to diagnose definitely
Date of disclosure of the study information 2021/05/11
Last modified on 2021/05/11

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Basic information
Public title Feasibility study of CT colonography for peritoneal metastasis of gastric cancer clinically difficult to diagnose definitely
Acronym Feasibility study of CT colonography for peritoneal metastasis of gastric cancer clinically difficult to diagnose definitely
Scientific Title Feasibility study of CT colonography for peritoneal metastasis of gastric cancer clinically difficult to diagnose definitely
Scientific Title:Acronym Feasibility study of CT colonography for peritoneal metastasis of gastric cancer clinically difficult to diagnose definitely
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 CTC will be performed aiming at improvement of diagnostic performance in patients in whom peritoneal metastasis/recurrence of stomach cancer is suspected based on physical, laboratory test, and imaging findings, but no definite diagnosis can be made. The presence or absence of deformation suggesting peritoneal dissemination in the large intestinal wall will be diagnosed jointly by the physician in charge and radiologist and correlation with the clinical course will be analyzed.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The primary endpoint of this study was the diagnostic sensitivity of CTC for PM. The secondary endpoints included overall survival (OS) and progression-free survival (PFS). Ideally, a pathological diagnosis is required to confirm PM; however, suspicious PM lesions detected by CTC are difficult to confirm using endoscopy or laparoscopy. Thus, we adopted the wait-and-see method to confirm PM. Patients were followed-up until the definitive development of PM. In this cohort study, the treatment to be administered after PM diagnosis was not specified. Accordingly, decisions regarding the timing of treatment initiation and the treatments to be administered were made on a case-by-case basis after a discussion between the patient and attending doctors. However, fluorouracil-compound plus cisplatin was administered as first-line chemotherapy when the patient did not undergo gastrectomy or developed recurrence, with the interval between S-1 adjuvant chemotherapy and recurrence being <6 months. All oncological definitions were in accordance with the Japanese Classification of Gastric Carcinoma 15th edition
Key secondary outcomes The primary endpoint of this study was the diagnostic sensitivity of CTC for PM. The secondary endpoints included overall survival (OS) and progression-free survival (PFS). Ideally, a pathological diagnosis is required to confirm PM; however, suspicious PM lesions detected by CTC are difficult to confirm using endoscopy or laparoscopy. Thus, we adopted the wait-and-see method to confirm PM. Patients were followed-up until the definitive development of PM. In this cohort study, the treatment to be administered after PM diagnosis was not specified. Accordingly, decisions regarding the timing of treatment initiation and the treatments to be administered were made on a case-by-case basis after a discussion between the patient and attending doctors. However, fluorouracil-compound plus cisplatin was administered as first-line chemotherapy when the patient did not undergo gastrectomy or developed recurrence, with the interval between S-1 adjuvant chemotherapy and recurrence being <6 months. All oncological definitions were in accordance with the Japanese Classification of Gastric Carcinoma 15th edition

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 In this study, we aimed to use CTC for early detection of PM in patients in whom PM was suspected based on clinical symptoms and general CT findings but not yet diagnosed, and to administer anticancer agents in a timely and effective manner.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inclusion criteria
(i) histologically diagnosed gastric cancer via endoscopic biopsy or surgical specimen retrieval; (ii) suspected PM/recurrence of gastric cancer based on at least one of the following clinical findings: abnormal physical symptoms with causes that could not be explained by other diseases, elevation of serum tumor markers, and suspicious but not definitive signs of PM on conventional CT images; (iii) Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; (iv) oral intake ability; and (v) provision of written consent by each patient.
Key exclusion criteria Exclusion criteria were
(i) inability to undergo bowel preparation; (ii) obvious intestinal stenosis; (iii) presence of massive ascites; and (iv) inability to undergo carbon dioxide (CO2) insufflation through the rectum.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name Haruhiko
Middle name
Last name Cho
Organization Kanagawa Cancer Center
Division name Department of Gastrointestinal Surgery
Zip code 241-0815
Address 2-3-2 Nakao, Asahi Ward, Yokohama, Kanagawa, Japan
TEL 045-391-5761
Email choharuhiko@kcch.jp

Public contact
Name of contact person
1st name Rika
Middle name
Last name Takahashi
Organization Kanagawa Cancer Center
Division name Department of Gastrointestinal Surgery
Zip code 241-0815
Address 2-3-2 Nakao, Asahi Ward, Yokohama, Kanagawa, Japan
TEL 045-391-5761
Homepage URL
Email rika.takahasi@kcch.jp

Sponsor
Institute Department of Gastrointestinal Surgery, Kanagawa Cancer Center
Institute
Department

Funding Source
Organization Department of Gastrointestinal Surgery, Kanagawa Cancer Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Department of Gastrointestinal Surgery, Kanagawa Cancer Center
Address 2-3-2 Nakao, Asahi Ward, Yokohama, Kanagawa, Japan
Tel 045-391-5761
Email rika.takahasi@kcch.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 05 Month 11 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 18
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
2010 Year 06 Month 01 Day
Date of IRB
2010 Year 08 Month 01 Day
Anticipated trial start date
2010 Year 09 Month 20 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 12 Month 31 Day
Date analysis concluded
2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2021 Year 05 Month 11 Day
Last modified on
2021 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050436

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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