Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma
Investigation of a Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma
3 other identifiers
interventional
289
1 country
2
Brief Summary
In the current protocol, we propose a study to evaluate a novel, combined esophageal sponge-methylation biomarker strategy for the early detection of esophageal squamous cell carcinoma (ESCC) as well as its precursor, esophageal squamous dysplasia (ESD). This strategy leverages the 'EsophaCap', a swallowable, retrievable sponge, with subsequent evaluation of the sample using a novel molecular biomarker assay. This biomarker assay evaluates methylation levels in select genes, which have been shown to differ significantly between ESCC cases and controls in pilot studies. Detection of methylation markers highly associated with ESCC could help identify patients with concurrent ESCC or at high risk of imminently developing this condition. If successful, this strategy could result in a paradigm shift for esophageal cancer control strategies in Tanzania and other high-incidence ESCC regions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2021
CompletedFirst Posted
Study publicly available on registry
August 31, 2021
CompletedStudy Start
First participant enrolled
May 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMarch 30, 2025
March 1, 2025
3.6 years
August 25, 2021
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of True-Positives (sensitivity) detected with the EsoCAN assay after specimen collection using 'EsophaCap' sponge sampling (ESCC cases & controls only)
The proportion of participants with a positive EsoCAN assay result, among patients with histologically-confirmed Esophageal Squamous Cell Carcinoma (ESCC). The following equation will be used as a cut point for ESCC using the EsoCAN assay \[0.139\*log2(gene A)\] + \[0.176\* log2(gene B)\] + \[0.185\* log2(gene C)\], whereas a cutoff value (for the numerical index produced by this formula) of greater than -2.327 is classified as positive.
Up to 38 days
Proportion of True-Negatives (specificity) detected with the EsoCAN assay after specimen collection using 'EsophaCap' sponge sampling (ESCC cases & controls only)
The proportion of participants with a negative EsoCAN assay result for will be reported, among study participants who are classified as controls. The following equation will be used as a cut point for ESCC using the EsoCAN assay \[0.139\*log2(gene A)\] + \[0.176\* log2(gene B)\] + \[0.185\* log2(gene C)\], whereas a cutoff value (for the numerical index produced by this formula) of less than -2.327 is classified as negative.
Up to 38 days
Secondary Outcomes (5)
Proportion of True-Positives (sensitivity) detected with the EsoCAN assay after specimen collection using 'EsophaCap' sponge sampling (ESD cases & controls only)
Up to 38 days
Proportion of True-Negatives (specificity) detected with the EsoCAN assay after specimen collection using 'EsophaCap' sponge sampling (ESD cases & controls only)
Up to 38 days
Proportion of study participants who successfully swallow the esophageal sponge device
Up to 38 days
Proportion of study participants who experienced an esophageal sponge device-related adverse event in the lead in cohort of ESCC Cases
Up to 38 days
Median Acceptability Scores
Up to 38 days
Study Arms (3)
Esophageal Squamous Cell Carcinoma (ESCC) Cases
EXPERIMENTALEach study participant will undergo esophageal sponge sampling using the 'EsophaCap' sponge device. Group 1 will include a safety-phase, which will consist of a lead-in cohort of 8 patients with ESCC. Subsequent recruitment of ESCC Cases (Group 1) will not commence until the Data Safety Monitoring Board (DSMB) has deemed the safety lead-in data appropriate for continuation. Following collection of esophageal cells, samples will be assessed using the EsoCAN assay. Study participant evaluations will be taken at baseline, immediately after undergoing esophageal sponge sampling, and 7 days following administration of the 'EsophaCap' device.
Non-ESCC, Esophageal squamous dysplasia (ESD) Cases
EXPERIMENTALEach study participant will undergo (1) Esophagogastroduodenoscopy (EGD) with chromoendoscopic screening and possible biopsy, and (2) esophageal sponge sampling using the 'EsophaCap' sponge device. Pathology from chromoendoscopic screening will be used to categorize non-ESCC study participants as esophageal squamous dysplasia (ESD) cases and controls. Following collection of esophageal cells, samples will be assessed using the EsoCAN assay. Study participant evaluations will be taken at baseline, immediately after undergoing esophageal sponge sampling, and 7 days following administration of the 'EsophaCap' device.
Non-ESCC, Control Group
EXPERIMENTALEach study participant will undergo (1) Esophagogastroduodenoscopy (EGD) with chromoendoscopic screening and possible biopsy, and (2) esophageal sponge sampling using the 'EsophaCap' sponge device. Pathology from chromoendoscopic screening will be used to categorize non-ESCC study participants as esophageal squamous dysplasia (ESD) cases and controls. Following collection of esophageal cells, samples will be assessed using the EsoCAN assay. Study participant evaluations will be taken at baseline, immediately after undergoing esophageal sponge sampling, and 7 days following administration of the 'EsophaCap' device.
Interventions
Non-invasive strategy to sample esophageal tissue
Lugol's iodine chromoendoscopy is a technique that is used to identify mucosal abnormalities of the esophagus
Biomarker Test
Eligibility Criteria
You may qualify if:
- ESCC Cases (Group 1):
- Male or female \>= 18 years of age at screening visit.
- Patients are currently seen for clinical care at Muhimbili National Hospital (MNH)-Upanga or at MNH-Mloganzila.
- Patient meets one of the following two criteria-
- Patients with a confirmed diagnosis of ESCC as evidenced by histological confirmation OR
- Patient planned to undergo EGD with biopsy for suspected ESCC based upon any one of the following clinical criteria: (1) findings on computed tomography (CT) scan; (2) findings on barium swallow; (3) findings on endoscopy without biopsy confirmation, (4) symptoms of dysphagia and/or odynophagia without an alternative explanation for these symptoms.
- Patient must be able to swallow liquid (Ogilvie's score \< 3).
- Patients must be well enough to participate in a 20-minute interview or have a close relative who is able to do so on their behalf.
- Patients must be willing to be contacted either in person or via phone 7-10 days following administration of the 'EsophaCap' sponge device.
- Native of Tanzania.
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- Non-ESCC study participants (Group 2):
- Male or female ≥ 18 years of age at screening visit.
- Patients are currently seen for clinical care at MNH-Upanga or at MNH-Mloganzila.
- Patient is scheduled to undergo EGD for a suspected non-malignant condition with no symptoms concerning for esophageal cancer (i.e. dysphagia or odynophagia).
- +5 more criteria
You may not qualify if:
- ESCC Cases (Group 1):
- Known pregnancy during participation in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Clinical instability (i.e. hypotension or a recent cardiovascular event).
- Any history of upper gastrointestinal bleeding within the past 3 months (including reported history of hematemesis and/or melena).
- Diagnosis of peptic ulcer disease within the last 3 months.
- Known history of esophageal varices.
- Patients taking anticoagulation or antiplatelet therapy/medication (warfarin, clopidogrel, aspirin, heparin or enoxaparin) for high-risk conditions.
- Patients with an active extra-esophageal malignancy (not currently in remission).
- Patient with a known history of a non-malignant esophageal stricture.
- Patients with esophageal stents currently in place.
- Patients with a history of radiation therapy to the head, neck, any part of the gastrointestinal tract (including esophagus) or thorax.
- Patients who have previously received chemotherapy in the last 12 months
- Patients with any history of major surgery for esophageal cancer (e.g. esophageal bypass, esophagectomy, etc.).
- Patients who have a known history of or clinical symptoms concerning for tracheoesophageal fistula (aspiration history, severe cough)
- +28 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- National Cancer Institute (NCI)collaborator
- Johns Hopkins Universitycollaborator
- Muhimbili University of Health and Allied Sciencescollaborator
- CapNostics, LLCcollaborator
Study Sites (2)
Muhimbili National Hospital (MNH)
Dar es Salaam, Mloganzila, Tanzania
Muhimbili National Hospital (MNH)
Dar es Salaam, Upganda, Tanzania
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geoffrey Buckle, MD, MPH
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2021
First Posted
August 31, 2021
Study Start
May 16, 2022
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
March 30, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share