臨床研究等提出・公開システム

Date of registration	April. 23, 2022
Last modified on	Aug. 01, 2025
Trial ID	jRCT1040220010

Scientific Title	An observational study on treatment patterns and outcomes among patients with metastatic or recurrent esophageal cancer: Real world data and empirical analysis in Japan (POME)
Public Title	POME (POME)

Contact for Scientific Queries	Name	Kei Muro
	Affiliation	Department of Clinical Oncology, Aichi Cancer Center
	Address	1-1 Kanokoden, Chikusa-ku, Nagoya-shi, Aichi
	Telephone	+81-52-762-6111
	E-mail	kmuro@aichi-cc.jp
Contact for Public Queries	Name	Kadowaki Shigenori
	Affiliation	Department of Clinical Oncology, Aichi Cancer Center
	Address	1-1 Kanokoden, Chikusa-ku, Nagoya-shi, Aichi
	Telephone	+81-52-762-6111
	E-mail	skadowaki@aichi-cc.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		April. 23, 2022
Actual date of first enrollment		Sept. 09, 2022
Target sample size		1000
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1.Patients diagnosed with metastatic or recurrent esophageal squamous or adenosquamous cancer from January 1, 2013 to December 31, 2018 2. Age: 20 years or older 3. Patients in the above categories (1) to (4) of patients eligible for chemotherapy for esophageal cancer from January 2013 to the end of December 2018 who have received chemotherapy for metastasis or recurrence 4. Patients from whom appropriate consent is obtained (see General Informed Consent) All inclusion and exclusion criteria will be reviewed by the investigator or qualified designee to ensure that the subject qualifies for the study.
	Exclusion Criteria	Patients who were registered in a clinical study at the time of the first chemotherapy treatment for metastatic or recurrent esophageal cancer
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		esophageal cancer
Health Condition(s) Keyword		esophageal cancer
Primary Outcome(s)		To investigate the patterns of treatment in patients who received a histological diagnosis of esophageal cancer (squamous, adenosquamous) who started chemotherapy for metastatic or recurrent esophageal cancer from January 1, 2013 to December 31, 2018.
Secondary Outcome(s)		OS, clinical course (response rate, recurrence or metastasis, duration) and timings by type of chemotherapy, factors affecting outcomes

Primary Sponsor	MSD K.K., Tokyo, Japan

Secondary Sponsor

Source of Monetary Support	MSD K.K., Tokyo, Japan
Secondary Sponsor	Not applicable

Name of Certified Review Board	Aichi Cancer Center Institutional Review Board
Address	1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan, Aichi
Telephone	+81-52-762-6111
E-Mail	irb@aichi-cc.jp
Approval Status	Approval
Date of approval	April. 14, 2022

Name of Certified Review Board	Gunma University Hospital Clinical Research Review Board
Address	3-39-15 Showa-machi, Maebashi, Gunma, Aichi
Telephone	+81-27-220-8740
Approval Status	Approval
Date of approval	April. 14, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Aug. 01, 2025	(this page)	Changes
3	Dec. 25, 2022	Detail	Changes
2	Sept. 27, 2022	Detail	Changes
1	April. 23, 2022	Detail

List of change history