A prospective study of the usefulness of next-generation sequencing, circulating tumor DNA (ctDNA), and exosome DNA as biomarkers in esophageal squamous cell carcinoma

A prospective study of the usefulness of next-generation sequencing, circulating tumor DNA (ctDNA), and exosome DNA as biomarkers in esophageal squamous cell carcinoma - A prospective study of the usefulness of next-generation sequencing, circulating tumor DNA (ctDNA), and exosome DNA as biomarkers in esophageal squamous cell carcinoma

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000045311

Enrollment

Registered

2021-09-01

Start date

2021-03-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal squamous cell cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patients are planned to treat according to our protocol for the treatment of esophageal squamous cell carcinoma.

Exclusion criteria

Exclusion criteria: The patients follow our standard treatment protocol of esophageal squamous cell carcinoma.

Design outcomes

Primary

Measure	Time frame
The correlation of the dose of ctDNA and exosome DNA during treatment and the survival.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactTomoki Nakai

2nd department of surgery, Wakayama medical university 2nd department of surgery

nakai@wakayama-med.ac.jp073-441-0613

Outcome results