Unique ID issued by UMIN | UMIN000038724 |
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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 |
Tumor burden monitoring with circulating tumor DNA in esophageal squamous cell carcinoma patients
Circulating tumor DNA monitoring in esophageal cancer
Tumor burden monitoring with circulating tumor DNA in esophageal squamous cell carcinoma patients
Circulating tumor DNA monitoring in esophageal cancer
Japan |
esophageal squamous cell carcinoma
Gastroenterology | Gastrointestinal surgery |
Malignancy
YES
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.
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.
Exploratory
Not applicable
ctDNA dynamics and clinical relapse by conventional surveillance modalities are compared if ctDNA provides useful information on the early detection of relapse.
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
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
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
100
1st name | Takeshi |
Middle name | |
Last name | Iwaya |
Iwate Medical University Hospital
Department of Surgery
0283695
2-1-1 Idaidori, Yahaba, Iwate
0196137111
tiwaya@iwate-med.ac.jp
1st name | Takeshi |
Middle name | Iwaya |
Last name | Iwaya |
Iwate Medical University Hospital
Department of Surgery
0283695
2-1-1 Idaidori, Yahaba, Iwate
0196137111
tiwaya@iwate-med.ac.jp
Iwate Medical University
Department of Surgery, Iwate Medical University
Other
Institutional review board, Iwate Medical University
2-1-1 Idaidori, Yahaba, Iwate
0196137111
kenkyu-rinri@j.iwate-med.ac.jp
NO
岩手医科大学附属病院(岩手県)
2019 | Year | 11 | Month | 30 | Day |
Partially published
https://www.sciencedirect.com/science/article/abs/pii/S0016508520352161?via%3Dihub
36
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.
2021 | Year | 08 | Month | 06 | Day |
Completed
2015 | Year | 09 | Month | 14 | Day |
2015 | Year | 09 | Month | 14 | Day |
2015 | Year | 09 | Month | 23 | Day |
2021 | Year | 12 | Month | 31 | Day |
Mutations in primary esophageal cancer and digital PCR Probe/primer library for specific mutations
2019 | Year | 11 | Month | 29 | Day |
2022 | Year | 12 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044148
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