To hear about similar clinical trials, please enter your email below
Trial Title:
An Exploratory Study of ctDNA-MRD in Predicting the Efficacy of Esophageal Squamous Cell Carcinoma
NCT ID:
NCT05759325
Condition:
Squamous Cell Carcinoma of Esophagus
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Esophageal Neoplasms
Conditions: Keywords:
ESCC
ctDNA
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Summary:
The purpose of this study is to observe and evaluate the correlation between ctDNA-MRD
and the therapeutic effect and prognosis of stage II-IVA operable esophageal squamous
cell carcinoma.
Detailed description:
ESCC patients with II-IVA resection will undergo MRD examination at the following time:
the first examination is before the operation, the second examination is 7-10 days after
the operation, and then 1 month after the operation, 2 weeks after the end of adjuvant
treatment (if available), the follow-up period (every 3 months if there is no
postoperative treatment) and the progress (the progress of the disease confirmed by the
researcher), the patients will receive close MRD monitoring to evaluate the correlation
between ctDNA-MRD and therapeutic efficacy and prognosis.
Criteria for eligibility:
Study pop:
Esophageal squamous cell carcinoma patients who were initially diagnosed as stage II-IVA
(TNM V8) and planned to undergo radical surgery
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Patients with stage II-IVA Esophageal squamous cell carcinoma confirmed by clinical
pathological staging;
2. ≥18 years;
3. Eastern Cooperative Oncology Group performance status score (ECOG PS) is 0 ~ 1
points;
4. Expected survival time ≥ 6 months;
5. Patients agree and have the ability to follow the planned study visits, laboratory
tests and other research steps.
Exclusion Criteria:
1. Patients with other malignant tumors;
2. Patient had undergone surgery before admission;
3. Pregnant or lactating women;
4. Patients with other serious diseases;
5. Patients who could not understand the experiment content and could not cooperate
with them and refused to sign the informed consent form;
6. Patients with contraindications to radiotherapy and chemotherapy;
7. Other researchers think it is not suitable.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
March 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Guangzhou Institute of Respiratory Disease
Agency class:
Other
Source:
Guangzhou Institute of Respiratory Disease
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05759325
