UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038724
Receipt number 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 2022/12/01 11:08:07

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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 or person

Institute

Iwate Medical University

Institute

Department

Personal name



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

Partially published


Result

URL related to results and publications

https://www.sciencedirect.com/science/article/abs/pii/S0016508520352161?via%3Dihub

Number of participants that the trial has enrolled

36

Results

Among esophageal squamous cell cancer (ESCC)patients who recurred, ctDNA elevated with a median lead time of 149 days to the imaging diagnosis. Patients with decreased ctDNA within 3 months showed significantly better outcomes than did patients with ctDNA-positive. Frequent tumor burden monitoring using a small number of tumor-specific ctDNAs by dPCR enables prediction of relapse and chemotherapeutic efficacy, as well as relapse-free corroboration in management of ESCC patients.

Results date posted

2021 Year 08 Month 06 Day

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

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

2021 Year 12 Month 31 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

2022 Year 12 Month 01 Day



Link to view the page

Value
https://center6.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