Esophagus CancerEMERALDNCT06381583
A Liquid Biopsy for High-risk Pre-cancer Screening of Esophageal Adenocarcinoma
An observational study of Esophagus Cancer and Esophageal Cancer Stage, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This study aims to develop a highly sensitive, specific, and cost-effective blood assay for the early detection of esophageal adenocarcinoma and its precursor lesions, using advanced machine learning and state-of-the-art biological analyses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagus Cancer, Esophageal Cancer Stage, Esophageal Cancer
- What is being tested?
- EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)
- How many people
- 658 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2023to 24 Apr 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 years and older
- All sexes
- Adult, Older adult
Study population: Four independent cohorts of individuals who belong to one of the following five Negative endoscopic findings Barrett's esophagus, at least 3 cm long without low-grade dysplasia (at most) Barrett's esophagus, of any length, with low-grade dysplasia (at most) Barrett's esophagus, of any length, with high-grade dysplasia (at most) Esophageal adenocarcinoma (of any stage, including in situ [Tis]) Colorectal cancer
Who may be able to join
- All individuals included in the study need to have had an endoscopic evaluation at the time of blood sampling.
- Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.
- Received standard pathological and endoscopic diagnosis and assessment for cohort assignment.
Who cannot join
- Lack of written informed consent.
- Short segment Barrett's esophagus with no evidence of dysplasia
- Ultra-short segment Barrett's esophagus with no evidence of dysplasia
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91016
About this study
Official title: A Liquid Biopsy to Screen for Barrett's Esophagus, Dysplasia, and Esophageal Adenocarcinoma: the EMERALD Multi-center Study.
This study aims to develop a highly sensitive, specific, and cost-effective blood assay for the early detection of esophageal adenocarcinoma and its precursor lesions, using advanced machine learning and state-of-the-art biological analyses.
Read the detailed description
Esophageal adenocarcinoma (EAC) is a significant global health concern, ranking second in lethality (after pancreatic cancer). Despite being potentially preventable, it remains a leading cause of cancer-related deaths. Traditional screening methods have relied on an endoscopy-first approach to screen for the precursor of EAC, which is Barrett's esophagus (BE). After BE detection, BE is then regularly surveiled to monitor the development of dysplasia, which can be treated to prevent malignant transformation. An endoscopy-first approach is sensitive BE and, therefore, it lowers the risk of developing EAC but it also faces challenges such as invasiveness, cost, and patient compliance.
Non-invasive tests are more appealing to patients than invasive tests and can increase participation rates. Biomarker studies have shown promise, but existing tests lack sensitivity for early-stage EAC and, most importantly, to its precursor lesion BE. This is likely because they over-sampled analytes that are primarily expressed at the EAC end of the spectrum, but not in BE yet during the BE to EAC sequence.
This study proposes developing an innovative liquid biopsy test tailored for EAC and BE to address this. An ideal screening test should be minimally invasive, highly sensitive, and cost-effective. This test would optimize patient compliance and resource allocation by detecting both conditions from a single blood draw. More specifically, circulating microRNA (miRNA) analysis shows promise: tests based on cell-free microRNA (cf-miRNA) have demonstrated high sensitivity.
This study will develop a non-invasive blood test for BE and EAC in four phases:
- In silico genome-wide profiling of tissue miRNA to select the best candidates for biomarker panels.
- Prioritization of the biomarkers that are differentially expressed across the entire continuum of BE to EAC sequence, compared to the normal mucosa
- Transition of these biomarkers to a liquid biopsy assay, confirming their detectability in blood as well as their differential expression in cases compared to controls
- Utilizing machine learning to identify the most promising candidates and train algorithms for detecting EAC and BE, based on results from quantitative polymerase chain reaction (qPCR) analysis.
- Independently validating these signatures using diverse cohorts to ensure broad applicability and compare the effectiveness of the blood assay to standard care through retrospective and prospective studies.
This study aims to develop a highly sensitive, specific, and cost-effective liquid biopsy for early detection of BE and EAC. Success could transform clinical practice by preventing EAC through early detection of pre-malignant lesions. Innovations include incorporating pre-malignant lesions into screening. This approach could potentially reduce EAC mortality and incidence and pave the way for new clinical trials.
- Conditions
- Esophagus Cancer, Esophageal Cancer Stage, Esophageal Cancer, Esophageal Neoplasms, Esophagus Adenocarcinoma, Esophagus, Barrett
- Being tested
- EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)
- Keywords
- Early detection, Micro RNA, miRNA, Liquid biopsy, Dysplasia, Artificial Intelligence, Cancer detection, Long segment Barrett Esophagus, Screening, Surveillance
- Medical subject headings
- Esophageal Neoplasms, Adenocarcinoma Of Esophagus, Barrett Esophagus, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)Diagnostic test
A panel of circulating microRNA, whose expression level is tested in cell-free derived samples.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Esophageal Adenocarcinoma [Malignant Tissue] | Individuals who underwent endoscopy and were found to only have one of the following:
* Esophageal adenocarcinoma of any stage
* Esophageal adenocarcinoma confined to the mucosa (stage Tis) Receives: Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia) | |
| Patients with Esophageal Adenocarcinoma [Matching Normal Tissue] | Individuals who underwent endoscopy and were found to only have one of the following:
* Esophageal adenocarcinoma of any stage
* Esophageal adenocarcinoma confined to the mucosa (stage Tis) Receives: Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia) | |
| Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Test Cohort] | Individuals who underwent endoscopy and were found to only have one of the following:
* Barrett's Esophagus, with high-grade dysplasia, independently of Barrett's segment length
* Esophageal adenocarcinoma of any stage
* Esophageal adenocarcinoma confined to the mucosa (stage Tis) Receives: Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia) | |
| Patients with Low-Grade Dysplasia or Long Segment Barrett's Esophagus [Test Cohort] | Individuals who underwent endoscopy and were found to only have Barrett's Esophagus, with one of the following:
* Craniocaudal maximal extension of 3 cm or more
* Low-grade dysplasia at most, independently of Barrett's segment length Receives: Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia) | |
| Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Test Cohort] | Individuals who underwent endoscopy and were found not to have any Barrett's Esophagus or adenocarcinoma. Receives: Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia) | |
| Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Training] | Individuals who underwent endoscopy and were found to only have one of the following:
* Barrett's Esophagus, with high-grade dysplasia, independently of Barrett's segment length
* Esophageal adenocarcinoma of any stage
* Esophageal adenocarcinoma confined to the mucosa (stage Tis) Receives: Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia) | |
| Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Training Cohort] | Individuals who underwent endoscopy and were found not to have any Barrett's Esophagus or adenocarcinoma. Receives: Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia) | |
| Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Validation] | Individuals who underwent endoscopy and were found to only have one of the following:
* Barrett's Esophagus, with high-grade dysplasia, independently of Barrett's segment length
* Esophageal adenocarcinoma of any stage
* Esophageal adenocarcinoma confined to the mucosa (stage Tis) Receives: Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia) | |
| Patients with Low-Grade Dysplasia or Long Segment Barrett's Esophagus [ValidationCohort] | Individuals who underwent endoscopy and were found to only have Barrett's Esophagus, with one of the following:
* Craniocaudal maximal extension of 3 cm or more
* Low-grade dysplasia at most, independently of Barrett's segment length Receives: Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia) | |
| Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Validation Cohort] | Individuals who underwent endoscopy and were found not to have any Barrett's Esophagus or adenocarcinoma. Receives: Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
True positive rate: the probability of a positive test result, conditioned on the individual truly being positive
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Specificity
True negative rate: the probability of a negative test result, conditioned on the individual truly being negative
Measured: Through study completion, an average of 1 year
Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy)
A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start15 Apr 2023
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 658 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ajay Goel, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381583
- Sponsor's protocol ID
- 23228/EMERALD
- Acronym
- EMERALD
- Status last verified
- May 2024
- First submitted
- 19 Apr 2024
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data.
Publications
Miyoshi J, Mannucci A, Scarpa M, Gao F, Toden S, Whitsett T, Inge LJ, Bremner RM, Takayama T, Cheng Y, Bottiglieri T, Nagtegaal ID, Shrubsole MJ, Zaidi AH, Wang X, Coleman HG, Anderson LA, Meltzer SJ, Goel A; FINBAR-EMERALD collaborative group. Liquid biopsy to identify Barrett's oesophagus, dysplasia and oesophageal adenocarcinoma: the EMERALD multicentre study. Gut. 2025 Jan 17;74(2):169-181. doi: 10.1136/gutjnl-2024-333364.
PubMed 39562048
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Liquid Biopsy to Screen for Barrett's Esophagus, Dysplasia, and Esophageal Adenocarcinoma: the EMERALD Multi-center Study.
- ClinicalTrials.gov ID
- NCT06381583
- Acronym / sponsor ID
- EMERALD / 23228/EMERALD
- Conditions
- Esophagus Cancer, Esophageal Cancer Stage, Esophageal Cancer, Esophageal Neoplasms, Esophagus Adenocarcinoma, Esophagus, Barrett
- Keywords
- Early detection, Micro RNA, miRNA, Liquid biopsy, Dysplasia, Artificial Intelligence, Cancer detection, Long segment Barrett Esophagus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 658 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 24 Apr 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.
This study aims to develop a highly sensitive, specific, and cost-effective blood assay for the early detection of esophageal adenocarcinoma and its precursor lesions, using advanced machine learning and state-of-the-art biological analyses.
Detailed description
Esophageal adenocarcinoma (EAC) is a significant global health concern, ranking second in lethality (after pancreatic cancer). Despite being potentially preventable, it remains a leading cause of cancer-related deaths. Traditional screening methods have relied on an endoscopy-first approach to screen for the precursor of EAC, which is Barrett's esophagus (BE). After BE detection, BE is then regularly surveiled to monitor the development of dysplasia, which can be treated to prevent malignant transformation. An endoscopy-first approach is sensitive BE and, therefore, it lowers the risk of developing EAC but it also faces challenges such as invasiveness, cost, and patient compliance.
Non-invasive tests are more appealing to patients than invasive tests and can increase participation rates. Biomarker studies have shown promise, but existing tests lack sensitivity for early-stage EAC and, most importantly, to its precursor lesion BE. This is likely because they over-sampled analytes that are primarily expressed at the EAC end of the spectrum, but not in BE yet during the BE to EAC sequence.
This study proposes developing an innovative liquid biopsy test tailored for EAC and BE to address this. An ideal screening test should be minimally invasive, highly sensitive, and cost-effective. This test would optimize patient compliance and resource allocation by detecting both conditions from a single blood draw. More specifically, circulating microRNA (miRNA) analysis shows promise: tests based on cell-free microRNA (cf-miRNA) have demonstrated high sensitivity.
This study will develop a non-invasive blood test for BE and EAC in four phases:
- In silico genome-wide profiling of tissue miRNA to select the best candidates for biomarker panels.
- Prioritization of the biomarkers that are differentially expressed across the entire continuum of BE to EAC sequence, compared to the normal mucosa
- Transition of these biomarkers to a liquid biopsy assay, confirming their detectability in blood as well as their differential expression in cases compared to controls
- Utilizing machine learning to identify the most promising candidates and train algorithms for detecting EAC and BE, based on results from quantitative polymerase chain reaction (qPCR) analysis.
- Independently validating these signatures using diverse cohorts to ensure broad applicability and compare the effectiveness of the blood assay to standard care through retrospective and prospective studies.
This study aims to develop a highly sensitive, specific, and cost-effective liquid biopsy for early detection of BE and EAC. Success could transform clinical practice by preventing EAC through early detection of pre-malignant lesions. Innovations include incorporating pre-malignant lesions into screening. This approach could potentially reduce EAC mortality and incidence and pave the way for new clinical trials.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Patients with Esophageal Adenocarcinoma [Malignant Tissue] | – | Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)Individuals who underwent endoscopy and were found to only have one of the following: * Esophageal adenocarcinoma of any stage * Esophageal adenocarcinoma confined to the mucosa (stage Tis) |
| Patients with Esophageal Adenocarcinoma [Matching Normal Tissue] | – | Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)Individuals who underwent endoscopy and were found to only have one of the following: * Esophageal adenocarcinoma of any stage * Esophageal adenocarcinoma confined to the mucosa (stage Tis) |
| Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Test Cohort] | – | Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)Individuals who underwent endoscopy and were found to only have one of the following: * Barrett's Esophagus, with high-grade dysplasia, independently of Barrett's segment length * Esophageal adenocarcinoma of any stage * Esophageal adenocarcinoma confined to the mucosa (stage Tis) |
| Patients with Low-Grade Dysplasia or Long Segment Barrett's Esophagus [Test Cohort] | – | Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)Individuals who underwent endoscopy and were found to only have Barrett's Esophagus, with one of the following: * Craniocaudal maximal extension of 3 cm or more * Low-grade dysplasia at most, independently of Barrett's segment length |
| Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Test Cohort] | – | Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)Individuals who underwent endoscopy and were found not to have any Barrett's Esophagus or adenocarcinoma. |
| Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Training] | – | Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)Individuals who underwent endoscopy and were found to only have one of the following: * Barrett's Esophagus, with high-grade dysplasia, independently of Barrett's segment length * Esophageal adenocarcinoma of any stage * Esophageal adenocarcinoma confined to the mucosa (stage Tis) |
| Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Training Cohort] | – | Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)Individuals who underwent endoscopy and were found not to have any Barrett's Esophagus or adenocarcinoma. |
| Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Validation] | – | Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)Individuals who underwent endoscopy and were found to only have one of the following: * Barrett's Esophagus, with high-grade dysplasia, independently of Barrett's segment length * Esophageal adenocarcinoma of any stage * Esophageal adenocarcinoma confined to the mucosa (stage Tis) |
| Patients with Low-Grade Dysplasia or Long Segment Barrett's Esophagus [ValidationCohort] | – | Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)Individuals who underwent endoscopy and were found to only have Barrett's Esophagus, with one of the following: * Craniocaudal maximal extension of 3 cm or more * Low-grade dysplasia at most, independently of Barrett's segment length |
| Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Validation Cohort] | – | Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)Individuals who underwent endoscopy and were found not to have any Barrett's Esophagus or adenocarcinoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Four independent cohorts of individuals who belong to one of the following five Negative endoscopic findings Barrett's esophagus, at least 3 cm long without low-grade dysplasia (at most) Barrett's esophagus, of any length, with low-grade dysplasia (at most) Barrett's esophagus, of any length, with high-grade dysplasia (at most) Esophageal adenocarcinoma (of any stage, including in situ [Tis]) Colorectal cancer
Key inclusion criteria (3 listed)
- All individuals included in the study need to have had an endoscopic evaluation at the time of blood sampling.
- Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.
- Received standard pathological and endoscopic diagnosis and assessment for cohort assignment.
Key exclusion criteria (3 listed)
- Lack of written informed consent.
- Short segment Barrett's esophagus with no evidence of dysplasia
- Ultra-short segment Barrett's esophagus with no evidence of dysplasia
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 |
|---|---|---|
| EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)A panel of circulating microRNA, whose expression level is tested in cell-free derived samples. | Diagnostic test | Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Test Cohort], Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Training Cohort], Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Validation Cohort], Patients with Esophageal Adenocarcinoma [Malignant Tissue], Patients with Esophageal Adenocarcinoma [Matching Normal Tissue], Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Test Cohort], Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Training], Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Validation], Patients with Low-Grade Dysplasia or Long Segment Barrett's Esophagus [Test Cohort], Patients with Low-Grade Dysplasia or Long Segment Barrett's Esophagus [ValidationCohort] |
Primary outcome
Sensitivity
Time frame: Through study completion, an average of 1 year
True positive rate: the probability of a positive test result, conditioned on the individual truly being positive
2 secondary outcomes
Specificity
Time frame: Through study completion, an average of 1 year
Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy)
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Derived from this study: PubMed 39562048Miyoshi J, Mannucci A, Scarpa M, Gao F, Toden S, Whitsett T, Inge LJ, Bremner RM, Takayama T, Cheng Y, Bottiglieri T, Nagtegaal ID, Shrubsole MJ, Zaidi AH, Wang X, Coleman HG, Anderson LA, Meltzer SJ, Goel A; FINBAR-EMERALD collaborative group. Liquid biopsy to identify Barrett's oesophagus, dysplasia and oesophageal adenocarcinoma: the EMERALD multicentre study. Gut. 2025 Jan 17;74(2):169-181. doi: 10.1136/gutjnl-2024-333364.
- Individual participant dataSharing planned: Undecided. Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data.
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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.
Ajay Goel, PhD principal investigator
City of Hope Medical 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 Esophagus Cancer and Esophageal Cancer Stage, run by City of Hope Medical Center at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 10 May 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06381583, which also lists 1 linked publication.
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 10 May 2024.