UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027994 |
|---|---|
| Receipt number | R000031890 |
| Scientific Title | Multi institutional retrospective study on clinicopathological significance of serum p53 antibody in the patients with esophageal cancer |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2022/07/04 08:59:44 |
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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
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
eso.marker@ext.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031890
