Esophageal Squamous Cell CarcinomaNCT06561178
Individualized Tumor-Informed CtDNA Analysis for Monitoring Postoperative Recurrence in ESCC (NEOCRTEC2401)
An observational study of Esophageal Squamous Cell Carcinoma, run by Sun Yat-Sen University Cancer Center at 1 site in China.
Trial summary
The goal of this observational study or is to explore the correlation between dynamic changes in postoperative circulating tumor DNA (ctDNA) and recurrence risk using a novel, tumor-informed ctDNA detection technique, thus laying the foundation for further promoting ctDNA detection to guide postoperative adjuvant… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- molecular residual disease detection
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2024to 1 Jun 2028
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with esophageal squamous cell carcinoma who have not achieved pCR following neoadjuvant chemoradiotherapy and surgery.
Who may be able to join
- Operable locally advanced esophageal squamous cell carcinoma;
- Have received neoadjuvant chemoradiotherapy ± immunotherapy and have not achieved pCR after R0 resection;
- Can tolerate postoperative adjuvant immunotherapy;
- Sufficient baseline tumor tissue and blood samples available for NGS testing;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Consents to and is capable of complying with the scheduled study visits, treatment plans, laboratory tests, and other study procedures
- Expected postoperative survival time of ≥ 6 months.
Who cannot join
- Concurrent other malignant tumors;
- Lack of a detailed histopathological diagnostic report for determining the nature of the lesion;
- Severe and/or poorly controlled medical conditions that, in the investigator's judgment, could affect participation or interfere with study results;
- Any social/psychological issues that, in the investigator's judgment, make the patient unsuitable for participation;
- Unable to undergo long-term, regular postoperative follow-up at the current medical institution;
- Unwilling or unable to comply with the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Hong Yang, yanghong@sysucc.org.cn
About this study
Official title: Individualized Tumor-Informed Circulating Tumor DNA (ctDNA) Analysis for Monitoring Postoperative Recurrence Following Neoadjuvant Therapy in Esophageal Squamous Cell Carcinoma (NEOCRTEC2401)
The goal of this observational study or is to explore the correlation between dynamic changes in postoperative circulating tumor DNA (ctDNA) and recurrence risk using a novel, tumor-informed ctDNA detection technique, thus laying the foundation for further promoting ctDNA detection to guide postoperative adjuvant therapy decisions. This study focuses on patients with esophageal squamous cell carcinoma who did not achieve pCR following neoadjuvant therapy combined with surgical resection. The main question it aims to answer is:
Is there a correlation between postoperative ctDNA changes and tumor recurrence?
Participants will be asked to undergo postoperative ctDNA detection.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- molecular residual disease detection
- Keywords
- ctDNA, recurrence detection, esophageal squamous cell carcinoma
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
molecular residual disease detectionDiagnostic test
ctDNA detection
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the recurrence of patients and the quantitative measurement of circulating tumor DNA (ctDNA) concentration.
Correlation were evaluated based on the sensitivity and specificity of ctDNA in predicting recurrence.The sensitivity and specificity were determined by evaluating the association between positive ctDNA and tumor recurrence.
Measured: 3 years
Secondary outcomes (9)
Postoperative molecular residual disease (MRD) positive rate
Measured: 3 years
Correlation between ctDNA detection and postoperative adjuvant therapy.
The ctDNA assay was employed to inform postoperative adjuvant therapy, with the objective of determining its potential to enhance patient prognosis.
Measured: 3 years
correlation between patients' prognosis and landmark MRD status
The sensitivity and specificity were determined by evaluating the association between positive landmark MRD status and patients' prognosis.
Measured: 3 years
2-year disease-free survival
Measured: 2 years
3-year disease-free survival
Measured: 3 years
5-year disease-free survival
Measured: 5 years
2-year overall survival
Measured: 2 years
3-year overall survival
Measured: 3 years
5-year overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start26 Aug 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen University Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Hong, Sun Yat-sen University
- Investigators
- Hong Yang, M.D.;Ph.D., Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561178
- Sponsor's protocol ID
- B2024-302-01
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 29 Aug 2024
- 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 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Tumor-Informed Circulating Tumor DNA (ctDNA) Analysis for Monitoring Postoperative Recurrence Following Neoadjuvant Therapy in Esophageal Squamous Cell Carcinoma (NEOCRTEC2401)
- ClinicalTrials.gov ID
- NCT06561178
- Acronym / sponsor ID
- B2024-302-01
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- ctDNA, recurrence detection, esophageal squamous cell carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-Sen University Cancer CenterUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 19 Aug 2024 (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 goal of this observational study or is to explore the correlation between dynamic changes in postoperative circulating tumor DNA (ctDNA) and recurrence risk using a novel, tumor-informed ctDNA detection technique, thus laying the foundation for further promoting ctDNA detection to guide postoperative adjuvant therapy decisions. This study focuses on patients with esophageal squamous cell carcinoma who did not achieve pCR following neoadjuvant therapy combined with surgical resection. The main question it aims to answer is:
Is there a correlation between postoperative ctDNA changes and tumor recurrence?
Participants will be asked to undergo postoperative ctDNA detection.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with esophageal squamous cell carcinoma who have not achieved pCR following neoadjuvant chemoradiotherapy and surgery.
Key inclusion criteria (7 listed)
- Operable locally advanced esophageal squamous cell carcinoma;
- Have received neoadjuvant chemoradiotherapy ± immunotherapy and have not achieved pCR after R0 resection;
- Can tolerate postoperative adjuvant immunotherapy;
- Sufficient baseline tumor tissue and blood samples available for NGS testing;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
Key exclusion criteria (6 listed)
- Concurrent other malignant tumors;
- Lack of a detailed histopathological diagnostic report for determining the nature of the lesion;
- Severe and/or poorly controlled medical conditions that, in the investigator's judgment, could affect participation or interfere with study results;
- Any social/psychological issues that, in the investigator's judgment, make the patient unsuitable for participation;
- Unable to undergo long-term, regular postoperative follow-up at the current medical institution;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| molecular residual disease detectionctDNA detection | Diagnostic test | – |
Primary outcome
Correlation between the recurrence of patients and the quantitative measurement of circulating tumor DNA (ctDNA) concentration.
Time frame: 3 years
Correlation were evaluated based on the sensitivity and specificity of ctDNA in predicting recurrence.The sensitivity and specificity were determined by evaluating the association between positive ctDNA and tumor recurrence.
9 secondary outcomes
Postoperative molecular residual disease (MRD) positive rate
Time frame: 3 years
Correlation between ctDNA detection and postoperative adjuvant therapy.
Time frame: 3 years
correlation between patients' prognosis and landmark MRD status
Time frame: 3 years
2-year disease-free survival
Time frame: 2 years
3-year disease-free survival
Time frame: 3 years
5-year disease-free survival
Time frame: 5 years
2-year overall survival
Time frame: 2 years
3-year overall survival
Time frame: 3 years
5-year overall survival
Time frame: 5 years
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 29 Aug 2024.
- 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.
Hong Yang, M.D.;Ph.D. principal investigator
Sun Yat-Sen University Cancer Center
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 Esophageal Squamous Cell Carcinoma, run by Sun Yat-Sen University Cancer Center 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 6 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: looking for participants now, as of the sponsor's last update on 29 Aug 2024. 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?
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?
Contact Hong Yang, MD (86-020-87343932 ext. 020-87343932, yanghong@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the recurrence of patients and the quantitative measurement of circulating tumor DNA (ctDNA) concentration. (time frame: 3 years). 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 29 Aug 2024.