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Trial Title:
Efficacy Evaluation and Recurrence Monitoring of Therapy for Esophageal Squamous Cell Carcinoma Based on ctDNA-MRD.
NCT ID:
NCT05900583
Condition:
Minimal Residual Disease
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasm, Residual
Recurrence
Conditions: Keywords:
Minimal Residual Disease
Esophageal Squamous Cell Carcinoma
Efficacy Evaluation
Recurrence Monitoring
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Summary:
This project is focusing on who have locally advanced esophageal squamous cell carcinoma
and have undergone neoadjuvant and adjuvant therapy, followed by surgical resection. The
exclusive MRD (Minimal residual disease) probe consists of an exclusive "molecular label"
formulated according to the individual genome mutation profile and 21 critical tumor
driver genes. By continuously monitoring each patient's ctDNA dynamics, changes in ctDNA
concentration or ctDNA-MRD negative/positive results will serve as the primary indicators
to assess the efficacy and prognosis of patients with esophageal squamous cell carcinoma.
Detailed description:
The goal of this project is to recruit 50 patients who have locally advanced esophageal
squamous cell carcinoma and have undergone neoadjuvant and adjuvant therapy, followed by
surgical resection. Initially, tumor tissues from all patients will undergo a more
comprehensive NGS sequencing process (WESPlus) than whole-exome sequencing. This will
provide a complete genomic mutation profile for each patient. Subsequently, a specific
algorithm will be used to accurately select 20 mutation sites as the patient's unique
"molecular label." Additionally, 21 critical driver genes related to tumors will be
combined, leading to the creation of an exclusive MRD probe. This will enable
ultra-high-depth capture sequencing of ctDNA samples from patients at 100,000x. By
continuously monitoring each patient's ctDNA dynamics, changes in ctDNA concentration or
ctDNA-MRD negative/positive results will serve as the primary indicators to assess the
efficacy and prognosis of patients with esophageal squamous cell carcinoma.
Criteria for eligibility:
Study pop:
Patients diagnosed with locally advanced esophageal squamous cell carcinoma by imaging or
pathological examination: cT2-4N1-3M0, cT3-4N0M0 II-IVA (including IVB stage with
supraclavicular and abdominal lymph node metastasis);.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Age range from 18 to 80 years old;
- Patients diagnosed with locally advanced esophageal squamous cell carcinoma by
imaging or pathological examination: cT2-4N1-3M0, cT3-4N0M0 II-IVA (including IVB
stage with supraclavicular and abdominal lymph node metastasis);
- Receive neoadjuvant therapy;
- Must be able to obtain the patient's clinical information and clear pathological
diagnosis results;
- Able to cooperate with long-term follow-up, regular review, and blood sample
collection;
- Patients agree to participate in the tracking and follow-up of the group and provide
follow-up information;
- Must obtain the informed consent of the patient or their legal representative, and
the patient has the ability to cooperate to complete the requirements of the study.
Exclusion Criteria:
- Patients with other cancers or severe illnesses that result in shorter survival than
the trial follow-up period;
- Received other treatments (such as radiotherapy, etc.) before receiving neoadjuvant
therapy;
- Have contraindications to chemotherapy;
- Patients who received blood transfusions within three months prior to enrollment;
- HIV-positive patients or those with other immune system deficiency diseases;
- Pregnant patients;
- Alcohol or drug abusers;
- Other situations that the researchers believe may affect the experimental results or
are unethical.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Start date:
June 1, 2023
Completion date:
August 31, 2025
Lead sponsor:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
Haplox
Agency class:
Other
Source:
Guangdong Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05900583
