Esophageal Squamous Cell CarcinomaNCT05426850
ctDNA-based MRD Assessment in Local Advanced Esophageal Carcinoma
An observational study of Esophageal Squamous Cell Carcinoma, run by Fudan University at 1 site in China.
Trial summary
To analyze the relationship between the dynamic changes of circulating tumor DNA (ctDNA) and tumor relapse of esophageal squamous cell carcinoma treated by concurrent chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 Dec 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Local advanced esophageal squamous cell carcinoma treated by definitive concurrent chemoradiotherapy
Who may be able to join
- 18-75 years old.
- ECOG 0-1.
- Esophageal squamous cell carcinoma confirmed by pathology.
- No radiotherapy, chemotherapy, or other treatments prior to enrollment.
- Locally advanced esophageal squamous cell carcinoma (II-IVa, IVB with supraclavicular lymph node metastasis).
- No severe abnormal hematopoietic, cardiac, pulmonary, renal, hepatic function, or immunodeficiency.
- Informed consent signed.
Who cannot join
- Less than 50.4Gy/28fx of radiotherapy dose.
- Without Concurrent chemotherapy.
- Pregnant or breastfeeding women or fertile patients who refused to use contraceptives.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai cancer center
Shanghai, Shanghai Municipality, 200032
Kuaile Zhao, M.D., 86-18017312534, kuaile_z@sina.com
About this study
Official title: Circulating Tumor DNA-based Minimal Residual Disease (MRD) Assessment in Local Advanced Esophageal Squamous Cell Carcinoma Treated by Definitive Concurrent Chemoradiotherapy
To analyze the relationship between the dynamic changes of circulating tumor DNA (ctDNA) and tumor relapse of esophageal squamous cell carcinoma treated by concurrent chemoradiotherapy.
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| ctDNA(+) Cohort | ctDNA(+) Cohort in pretreatment and posttreatment plasma samples was defined by accessing the presence of one or more mutations identified in match tumor samples. | |
| ctDNA(-) Cohort | ctDNA(-) Cohort in pretreatment and posttreatment plasma samples was defined by the absence of one or more mutations identified in match tumor samples. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between ctDNA status after chemoradiotherapy and relapse.
To assess if recurrent esophageal cancer is detectable earlier by ctDNA positive in plasma.
Measured: ctDNA will be tested within 1 year after chemoradiotherapy
Secondary outcomes (4)
Changes of ctDNA status.
To dynamically evaluate the ctDNA status at baseline, during treatment and follow-up.
Measured: before and at the end of radiotherapy (+1 week); at the end of consolidation chemotherapy (+1 week); at 2 weeks, 1 month, 3 months, 6 months, 9 months, 1 year after dCCRT.
Overall survival (OS).
To compare OS in ctDNA(+) patients and ctDNA(-) patients.
Measured: through study completion, an average of 2 years.
Relapse-free survival (RFS) and progression-free survival (PFS).
To compare RFS and PFS in ctDNA(+) patients and ctDNA(-) patients.
Measured: through study completion, an average of 2 years.
Relationships between radiomics features, ctDNA status and relapse.
To assess if recurrent esophageal cancer is detectable earlier by ctDNA positive in plasma compared to traditional radiographic methods.
Measured: through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Jun 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Dec 2024 (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.
- More trials run by Fudan UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuai Le Zhao, MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426850
- Sponsor's protocol ID
- ESO-Shanghai16
- Status last verified
- Jun 2022
- First submitted
- 24 May 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA-based Minimal Residual Disease (MRD) Assessment in Local Advanced Esophageal Squamous Cell Carcinoma Treated by Definitive Concurrent Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT05426850
- Acronym / sponsor ID
- ESO-Shanghai16
- Conditions
- Esophageal Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 22 Jun 2022 (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.
To analyze the relationship between the dynamic changes of circulating tumor DNA (ctDNA) and tumor relapse of esophageal squamous cell carcinoma treated by concurrent chemoradiotherapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ctDNA(+) Cohort | – | –ctDNA(+) Cohort in pretreatment and posttreatment plasma samples was defined by accessing the presence of one or more mutations identified in match tumor samples. |
| ctDNA(-) Cohort | – | –ctDNA(-) Cohort in pretreatment and posttreatment plasma samples was defined by the absence of one or more mutations identified in match tumor samples. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Local advanced esophageal squamous cell carcinoma treated by definitive concurrent chemoradiotherapy
Key inclusion criteria (7 listed)
- 18-75 years old.
- ECOG 0-1.
- Esophageal squamous cell carcinoma confirmed by pathology.
- No radiotherapy, chemotherapy, or other treatments prior to enrollment.
- Locally advanced esophageal squamous cell carcinoma (II-IVa, IVB with supraclavicular lymph node metastasis).
Key exclusion criteria (3 listed)
- Less than 50.4Gy/28fx of radiotherapy dose.
- Without Concurrent chemotherapy.
- Pregnant or breastfeeding women or fertile patients who refused to use contraceptives.
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
Relationship between ctDNA status after chemoradiotherapy and relapse.
Time frame: ctDNA will be tested within 1 year after chemoradiotherapy
To assess if recurrent esophageal cancer is detectable earlier by ctDNA positive in plasma.
4 secondary outcomes
Changes of ctDNA status.
Time frame: before and at the end of radiotherapy (+1 week); at the end of consolidation chemotherapy (+1 week); at 2 weeks, 1 month, 3 months, 6 months, 9 months, 1 year after dCCRT.
Overall survival (OS).
Time frame: through study completion, an average of 2 years.
Relapse-free survival (RFS) and progression-free survival (PFS).
Time frame: through study completion, an average of 2 years.
Relationships between radiomics features, ctDNA status and relapse.
Time frame: through study completion, an average of 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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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.
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 Fudan University 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 3 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 22 Jun 2022. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between ctDNA status after chemoradiotherapy and relapse. (time frame: ctDNA will be tested within 1 year after chemoradiotherapy). 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 22 Jun 2022.