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

Sponsors

Lead Sponsor: Fudan University

Source Fudan University
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.

Overall Status Recruiting
Start Date 2021-06-01
Completion Date 2024-12-01
Primary Completion Date 2022-12-31
Study Type Observational
Primary Outcome
Measure Time Frame
Relationship between ctDNA status after chemoradiotherapy and relapse. ctDNA will be tested within 1 year after chemoradiotherapy
Secondary Outcome
Measure Time Frame
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.
Overall survival (OS). through study completion, an average of 2 years.
Relapse-free survival (RFS) and progression-free survival (PFS). through study completion, an average of 2 years.
Relationships between radiomics features, ctDNA status and relapse. through study completion, an average of 2 years.
Enrollment 100
Condition
Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Status: Contact: Fudan University Shanghai cancer center Kuaile Zhao, M.D. 86-18017312534 [email protected]
Location Countries

China

Verification Date

2022-06-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Fudan University

Investigator Full Name: Kuai Le Zhao, MD

Investigator Title: Professor

Has Expanded Access No
Condition Browse
Arm Group

Label: ctDNA(+) Cohort

Description: ctDNA(+) Cohort in pretreatment and posttreatment plasma samples was defined by accessing the presence of one or more mutations identified in match tumor samples.

Label: ctDNA(-) Cohort

Description: ctDNA(-) Cohort in pretreatment and posttreatment plasma samples was defined by the absence of one or more mutations identified in match tumor samples.

Study Design Info

Observational Model: Other

Time Perspective: Prospective

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