Minimal Residual DiseaseNCT05900583
Efficacy Evaluation and Recurrence Monitoring of Therapy for Esophageal Squamous Cell Carcinoma Based on ctDNA-MRD.
An observational study of Minimal Residual Disease and Esophageal Squamous Cell Carcinoma, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Minimal Residual Disease, Esophageal Squamous Cell Carcinoma
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 31 Aug 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 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);.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Evaluation and Recurrence Monitoring of Neoadjuvant Therapy and Adjuvant Therapy for Esophageal Squamous Cell Carcinoma Based on ctDNA-MRD.
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.
Read the 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.
- Keywords
- Minimal Residual Disease, Esophageal Squamous Cell Carcinoma, Efficacy Evaluation, Recurrence Monitoring
- Medical subject headings
- Neoplasm, Residual, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MRD positive group | Not described | |
| MRD negative group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response (pCR)
No residual tumor is the esophagus or dissected lymph nodes.
Measured: immediately after surgery
Secondary outcomes (2)
Recurrence-free survival (RFS)
The time from date of diagnosis to the time of recurrence or death.
Measured: 2 years
Overall survival (OS)
The time from date of diagnosis to the time of death.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Residual DiseaseStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haplox
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900583
- Sponsor's protocol ID
- RICE-MRD
- Status last verified
- Jun 2023
- First submitted
- 12 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation and Recurrence Monitoring of Neoadjuvant Therapy and Adjuvant Therapy for Esophageal Squamous Cell Carcinoma Based on ctDNA-MRD.
- ClinicalTrials.gov ID
- NCT05900583
- Acronym / sponsor ID
- RICE-MRD
- Keywords
- Minimal Residual Disease, Esophageal Squamous Cell Carcinoma, Efficacy Evaluation, Recurrence Monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Haplox
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 12 Jun 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRD positive group | – | – |
| MRD negative group | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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);.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
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
pathological complete response (pCR)
Time frame: immediately after surgery
No residual tumor is the esophagus or dissected lymph nodes.
2 secondary outcomes
Recurrence-free survival (RFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Minimal Residual Disease and Esophageal Squamous Cell Carcinoma, run by Guangdong Provincial People's Hospital at 1 site in China.
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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
pathological complete response (pCR) (time frame: immediately after surgery). 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 12 Jun 2023.