UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045311 |
|---|---|
| Receipt number | R000051751 |
| Scientific Title | A prospective study of the usefulness of next-generation sequencing, circulating tumor DNA (ctDNA), and exosome DNA as biomarkers in esophageal squamous cell carcinoma |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2026/03/04 10:08:19 |
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Basic information
Public title
A prospective study of the usefulness of next-generation sequencing, circulating tumor DNA (ctDNA), and exosome DNA as biomarkers in esophageal squamous cell carcinoma
Acronym
A prospective study of the usefulness of next-generation sequencing, circulating tumor DNA (ctDNA), and exosome DNA as biomarkers in esophageal squamous cell carcinoma
Scientific Title
A prospective study of the usefulness of next-generation sequencing, circulating tumor DNA (ctDNA), and exosome DNA as biomarkers in esophageal squamous cell carcinoma
Scientific Title:Acronym
A prospective study of the usefulness of next-generation sequencing, circulating tumor DNA (ctDNA), and exosome DNA as biomarkers in esophageal squamous cell carcinoma
Region
| Japan |
Condition
Condition
esophageal squamous cell cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate the efficacy of the treatment method and the determination of disease progression by using the next generation sequencer and measuring ctDNA and exosome DNA in patients diagnosed with esophageal squamous cell carcinoma and treated with standard therapy in our department, and to examine the validity of the treatment method.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlation of the dose of ctDNA and exosome DNA during treatment and the survival.
Key secondary outcomes
Correlation of ctDNA and exosome DNA levels before, during, and after treatment with recurrence-free survival
Correlation between ctDNA, exosome DNA levels and tumor markers
Correlation of ctDNA and exosome DNA levels with response rate to preoperative chemotherapy (RECIST Ver1.1) and disease control
Correlation of ctDNA and exosome DNA levels with the rate of decrease in SUVmax of the primary tumor by PET-CT scan
Correlation of ctDNA, exosome DNA levels with histological response to treatment (Grade based on Evans criteria for tumor cell disappearance)
Correlation between ctDNA, exosome DNA levels and resection rate
Correlation between the amount of ctDNA and exosome DNA and the curative resection rate (R1 or R0; R1: no gross cancer remnant, R0: no histological cancer remnant)
Comparison of ctDNA and exosome DNA levels in target genes with immunostaining results in surgically resected specimens
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients are planned to treat according to our protocol for the treatment of esophageal squamous cell carcinoma.
Key exclusion criteria
The patients follow our standard treatment protocol of esophageal squamous cell carcinoma.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Yamaue |
Organization
Wakayama medical university
Division name
2nd department of surgery
Zip code
641-8509
Address
811-1 Kimiidera Wakayama, Japan
TEL
073-441-0613
nakai@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | Nakai |
Organization
2nd department of surgery, Wakayama medical university
Division name
2nd department of surgery
Zip code
641-8509
Address
811-1 Kimiidera Wakayama, Japan
TEL
073-441-0613
Homepage URL
nakai@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university
Institute
Department
Personal name
Funding Source
Organization
Research expense
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Iwate medical university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama medical university
Address
811-1 Kimiidera Wakayama, Japan
Tel
073-441-0613
wa-rinri@wakayama-med.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 | 09 | 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
50
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Data analysis is currently in progress.
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
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2021 | Year | 08 | Month | 30 | Day |
Last modified on
| 2026 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051751
