Squamous Cell Carcinoma of EsophagusNCT05759325
An Exploratory Study of ctDNA-MRD in Predicting the Efficacy of Esophageal Squamous Cell Carcinoma
An observational study of Squamous Cell Carcinoma of Esophagus, run by Guangzhou Institute of Respiratory Disease.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Squamous Cell Carcinoma of Esophagus
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Esophageal squamous cell carcinoma patients who were initially diagnosed as stage II-IVA (TNM V8) and planned to undergo radical surgery
Who may be able to join
- Patients with stage II-IVA Esophageal squamous cell carcinoma confirmed by clinical pathological staging;
- ≥18 years;
- Eastern Cooperative Oncology Group performance status score (ECOG PS) is 0 ~ 1 points;
- Expected survival time ≥ 6 months;
- Patients agree and have the ability to follow the planned study visits, laboratory tests and other research steps.
Who cannot join
- Patients with other malignant tumors;
- Patient had undergone surgery before admission;
- Pregnant or lactating women;
- Patients with other serious diseases;
- Patients who could not understand the experiment content and could not cooperate with them and refused to sign the informed consent form;
- Patients with contraindications to radiotherapy and chemotherapy;
- Other researchers think it is not suitable.
About this study
Official title: Application of ctDNA-MRD in the Prediction of Curative Effect, Recurrence Monitoring and Prognosis Evaluation of Esophageal Squamous Cell Carcinoma (ESCC) During Perioperative Treatment
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.
Read the 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.
- Conditions
- Squamous Cell Carcinoma of Esophagus
- Keywords
- ESCC, ctDNA
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Evaluation of progression-free survival rate of esophageal squamous cell carcinoma patients with different MRD status during perioperative period
Measured: up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Liu, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759325
- Sponsor's protocol ID
- ESCC ctDNA-MRD
- Status last verified
- Feb 2023
- First submitted
- 25 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of ctDNA-MRD in the Prediction of Curative Effect, Recurrence Monitoring and Prognosis Evaluation of Esophageal Squamous Cell Carcinoma (ESCC) During Perioperative Treatment
- ClinicalTrials.gov ID
- NCT05759325
- Acronym / sponsor ID
- ESCC ctDNA-MRD
- Conditions
- Squamous Cell Carcinoma of Esophagus
- Keywords
- ESCC, ctDNA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Esophageal squamous cell carcinoma patients who were initially diagnosed as stage II-IVA (TNM V8) and planned to undergo radical surgery
Key inclusion criteria (5 listed)
- Patients with stage II-IVA Esophageal squamous cell carcinoma confirmed by clinical pathological staging;
- ≥18 years;
- Eastern Cooperative Oncology Group performance status score (ECOG PS) is 0 ~ 1 points;
- Expected survival time ≥ 6 months;
- Patients agree and have the ability to follow the planned study visits, laboratory tests and other research steps.
Key exclusion criteria (7 listed)
- Patients with other malignant tumors;
- Patient had undergone surgery before admission;
- Pregnant or lactating women;
- Patients with other serious diseases;
- Patients who could not understand the experiment content and could not cooperate with them and refused to sign the informed consent form;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival
Time frame: up to 2 year
Evaluation of progression-free survival rate of esophageal squamous cell carcinoma patients with different MRD status during perioperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma of Esophagus, run by Guangzhou Institute of Respiratory Disease.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: up to 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.