UMIN-CTR Clinical Trial

Basic information
Public title	Multi institutional retrospective study on clinicopathological significance of serum p53 antibody in the patients with esophageal cancer
Acronym	Retrospective study of p53 antibody with esophageal cancer
Scientific Title	Multi institutional retrospective study on clinicopathological significance of serum p53 antibody in the patients with esophageal cancer
Scientific Title:Acronym	Retrospective study of p53 antibody with esophageal cancer
Region	Japan

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

Objectives
Narrative objectives1	This study investigates the clinicopathological significance of tumor markers in the patients with esophageal cancer. Based on more than 1,000 cases retrospective analysis, the clinicopathological significance of serum p53 antibody is evaluated. This study approved by the Japan Esophageal Society.
Basic objectives2	Others
Basic objectives -Others	Clinicopathological significance
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-Tumor marker levels p53 antibody, CEA, SCC antigen, CYFRA 21-1 (CYFRA 21-1 is not essential) -Clinicopathological factors *UICC classification before surgery *Presence and detail of preoperative treatment and details (chemotherapy, radiation therapy) *Presence and detail of postoperative treatment and adjuvant chemotherapy (regimen, radiation therapy) *Recurrence site -Lavoratory data (CRP, T-cho, Alb, WBC)
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	-Esophageal cancer undergoing radical surgery (Histological type is not limited to squamous cell carcinoma but is applicable to all esophageal cancer) -More than one year has passed since the operation day until the registration date -Serum p53 antibody level and SCC antigen level measured before treatment
Key exclusion criteria	-Active multiple primary cancer (Synchronous or metachronous primary cancer within 5 years without disease-free disease, except that carcinoma in situ or intratumoral carcinoma lesion judged to be cured by topical treatment is active multiple primary cancer not included in cancer)
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Hideaki Middle name Last name Shimada
Organization	Toho University School of Medicine
Division name	Department of Surgery
Zip code	143-8541
Address	6-11-1 Omorinishi, Ota-ku, Tokyo, Japan
TEL	03-3762-4151
Email	hideaki.shimada@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Hideaki Middle name Last name Shimada
Organization	Toho University School of Medicine
Division name	Department of Surgery
Zip code	143-8541
Address	6-11-1 Omorinishi, Ota-ku, Tokyo, Japan
TEL	03-3762-4151
Homepage URL
Email	eso.marker@ext.toho-u.ac.jp

Sponsor
Institute	Toho University
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	The Japan Esophageal Society
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee Toho Univesity School of Medicine
Address	5-21-16 Omorinishi, Ota-ku, Tokyo, Japan
Tel	03-3762-4151
Email	med.rinri@ext.toho-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	2017 Year 07 Month 01 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	Completed
Date of protocol fixation	2016 Year 07 Month 20 Day
Date of IRB	2016 Year 07 Month 20 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multi institutional retrospective cohort study Registration: Over 1,000 patients in total at multi institution More than 100 cases registrations at each institution

Management information
Registered date	2017 Year 06 Month 29 Day
Last modified on	2022 Year 07 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031890