ctDNA-based MRD Assessment in Local Advanced Esophageal Carcinoma

Circulating Tumor DNA-based Minimal Residual Disease (MRD) Assessment in Local Advanced Esophageal Squamous Cell Carcinoma Treated by Definitive Concurrent Chemoradiotherapy

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05426850

Enrollment

100

Registered

2022-06-22

Start date

2021-06-01

Completion date

2024-12-01

Last updated

2022-06-22

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

Conditions

Esophageal Squamous Cell Carcinoma

Brief summary

To analyze the relationship between the dynamic changes of circulating tumor DNA (ctDNA) and tumor relapse of esophageal squamous cell carcinoma treated by concurrent chemoradiotherapy.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. 18-75 years old. 2. ECOG 0-1. 3. Esophageal squamous cell carcinoma confirmed by pathology. 4. No radiotherapy, chemotherapy, or other treatments prior to enrollment. 5. Locally advanced esophageal squamous cell carcinoma (II-IVa, IVB with supraclavicular lymph node metastasis). 6. No severe abnormal hematopoietic, cardiac, pulmonary, renal, hepatic function, or immunodeficiency. 7. Informed consent signed.

Exclusion criteria

1. Less than 50.4Gy/28fx of radiotherapy dose. 2. Without Concurrent chemotherapy. 3. Pregnant or breastfeeding women or fertile patients who refused to use contraceptives.

Design outcomes

Primary

Measure	Time frame	Description
Relationship between ctDNA status after chemoradiotherapy and relapse.	ctDNA will be tested within 1 year after chemoradiotherapy	To assess if recurrent esophageal cancer is detectable earlier by ctDNA positive in plasma.

Secondary

Measure	Time frame	Description
Changes of ctDNA status.	before and at the end of radiotherapy (+1 week); at the end of consolidation chemotherapy (+1 week); at 2 weeks, 1 month, 3 months, 6 months, 9 months, 1 year after dCCRT.	To dynamically evaluate the ctDNA status at baseline, during treatment and follow-up.
Overall survival (OS).	through study completion, an average of 2 years.	To compare OS in ctDNA(+) patients and ctDNA(-) patients.
Relapse-free survival (RFS) and progression-free survival (PFS).	through study completion, an average of 2 years.	To compare RFS and PFS in ctDNA(+) patients and ctDNA(-) patients.
Relationships between radiomics features, ctDNA status and relapse.	through study completion, an average of 2 years.	To assess if recurrent esophageal cancer is detectable earlier by ctDNA positive in plasma compared to traditional radiographic methods.

Countries

China

Outcome results