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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038724
Receipt No. R000044148
Scientific Title Tumor burden monitoring with circulating tumor DNA in esophageal squamous cell carcinoma patients
Date of disclosure of the study information 2019/11/30
Last modified on 2019/11/29

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Basic information
Public title Tumor burden monitoring with circulating tumor DNA in esophageal squamous cell carcinoma patients
Acronym Circulating tumor DNA monitoring in esophageal cancer
Scientific Title Tumor burden monitoring with circulating tumor DNA in esophageal squamous cell carcinoma patients
Scientific Title:Acronym Circulating tumor DNA monitoring in esophageal cancer
Region
Japan

Condition
Condition esophageal squamous cell carcinoma
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 This study is longitudinal frequent monitoring of circulating tumor DNA (ctDNA) by digital PCR using individual tumor-specific mutations in a daily practice of esophageal squamous cell cancer (ESCC) patients.
Basic objectives2 Others
Basic objectives -Others The aim of this study is to elucidate whether frequent tumor burden monitoring with ctDNA of a small number of individual tumor-specific mutations using digital PCR (dPCR) provides clinically useful information in daily practice for ESCC patients. With longitudinal ctDNA monitoring during treatment in addition to routine surveillance, ctDNA dynamics and clinical relapse by conventional surveillance modalities are compared if ctDNA provides useful information such as the early detection of relapse.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes ctDNA dynamics and clinical relapse by conventional surveillance modalities are compared if ctDNA provides useful information on the early detection of relapse.
Key secondary outcomes 1. Association of ctDNA detection and tumor stage or tumor volume
2. ctDNA monitoring and accurate diagnosis of chemotherapy/chemoradiotherapy efficacy
3. ctDNA monitoring and disease-free confirmation
4. Pretreatment ctDNA detection and overall survival
5. Clearance of ctDNA and overall survival

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients aged 20 or older with ESCC who underwent esophageal cancer treatment including surgery, chemotherapy, and radiotherapy.
1. Patients must have given written an informed consent
2. Histologically confirmed ESCC
3. ESCC Patients treated by standard of care therapy followed by post-treatment surveillance
Key exclusion criteria 1. Patients unable to undergo biopsy for initial tissue diagnosis
2. Patients who do not wish to pursue standard of care therapy
3. Patients with different diagnosis of malignancy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Iwaya
Organization Iwate Medical University Hospital
Division name Department of Surgery
Zip code 0283695
Address 2-1-1 Idaidori, Yahaba, Iwate
TEL 0196137111
Email tiwaya@iwate-med.ac.jp

Public contact
Name of contact person
1st name Takeshi
Middle name Iwaya
Last name Iwaya
Organization Iwate Medical University Hospital
Division name Department of Surgery
Zip code 0283695
Address 2-1-1 Idaidori, Yahaba, Iwate
TEL 0196137111
Homepage URL
Email tiwaya@iwate-med.ac.jp

Sponsor
Institute Iwate Medical University
Institute
Department

Funding Source
Organization Department of Surgery, Iwate Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Institutional review board, Iwate Medical University
Address 2-1-1 Idaidori, Yahaba, Iwate
Tel 0196137111
Email kenkyu-rinri@j.iwate-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 岩手医科大学附属病院(岩手県)

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 30 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 65
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
2015 Year 09 Month 14 Day
Date of IRB
2015 Year 09 Month 14 Day
Anticipated trial start date
2015 Year 09 Month 23 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Mutations in primary esophageal cancer and digital PCR Probe/primer library for specific mutations

Management information
Registered date
2019 Year 11 Month 29 Day
Last modified on
2019 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044148

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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