Esophageal Squamous Cell CarcinomaNCT05028725
Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma
A study testing EsophaCap Sponge, Chromoendoscopy and EsoCAN assay in people with Esophageal Squamous Cell Carcinoma and Esophageal Squamous Dysplasia, run by University of California, San Francisco at 2 sites in Tanzania.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Esophageal Squamous Dysplasia
- What is being tested?
- EsophaCap Sponge, Chromoendoscopy and EsoCAN assay
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 2 sitesTanzania
- Study dates
- 16 May 2022to 31 Dec 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
- 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 participant or participant's legal representative and ability for subject to comply with the requirements of the study.
Who cannot join
- 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.
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- 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)
- Patients with a known history of small bowel obstruction
- Patients with a history of bleeding complications during esophageal biopsy.
- Patients with any history of a head and neck malignancy.
- Patients with a known bleeding disorder
- Patients with known thrombocytopenia (less than 50,000 platelets per microliter)
- Individuals who are not permanent residents or natives of Tanzania.
- Inability to follow instructions.
- Unable to provide informed consent.
- Non-ESCC study participants (Group 2):
- 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) or any history of a non-cutaneous malignancy diagnosed within the previous five years.
- Patient with a known history of esophageal strictures disabling passage of the capsule.
- Patient 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 with a known history of small bowel obstruction
- Patients with a known bleeding disorder
- Patients with known thrombocytopenia (less than 50,000 platelets per microliter)
- Individuals who are not permanent residents or natives of Tanzania.
- Allergy to iodine
- Presence of goiter.
- Inability to follow instructions.
- Unable to provide informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tanzania2 sites, 2 recruiting
- Recruiting
Muhimbili National Hospital (MNH)
Dar es Salaam, Mloganzila
Yona Ringo, +255 756 680 746, yona.skills@gmail.com
- Recruiting
Muhimbili National Hospital (MNH)
Dar es Salaam, Upganda
Yona Ringo, +255 756 680 746, yona.skills@gmail.com
About this study
Official title: Investigation of a Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the sensitivity and specificity of a diagnostic strategy combining esophageal sponge sampling with the 'EsophaCap' sponge device with use of the EsoCAN assay, a novel molecular biomarker assay, among patients with histologically-confirmed ESCC cases and controls.
SECONDARY OBJECTIVES:
- To evaluate the sensitivity and specificity of a diagnostic strategy combining esophageal sponge sampling with the 'EsophaCap' sponge device with use of the the EsoCAN assay, among patients with histologically-confirmed ESD and controls.
II. To evaluate the safety and feasibility of 'EsophaCap' a swallowable and retrievable sponge, as a non-invasive strategy for screening and early detection of ESCC and its precursor, ESD, in Tanzania.
EXPLORATORY OBJECTIVES:
- Sensitivity and specificity of esophageal sponge sampling with standard cytological examination among histologically-confirmed ESCC cases and controls.
II. Sensitivity and specificity of esophageal sponge sampling with standard cytological examination among histologically-confirmed ESD cases and controls.
III. To examine methylation levels in new and previously identified genes among patients recruited as suspected ESCC cases who are found to have an alternative diagnosis, with the goal of optimizing the EsoCAN Assay.
OUTLINE:
Each participant will undergo esophageal sponge sampling suing the 'EsophaCap' sponge device. Participants will be on study for up to 38 days.
- Being tested
- EsophaCap Sponge, Chromoendoscopy, EsoCAN assay
- Keywords
- EsophaCap, Biomarker Detection, Cancer Detection, Chromoendoscopic screening
- 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.
EsophaCap SpongeDevice
Also called EsophaCap Sponge Device, EsophaCap Swallowable Sponge device
Non-invasive strategy to sample esophageal tissue
ChromoendoscopyProcedure or surgery
Also called Lugol's iodine chromoendoscopy, Chromoendoscopic screening
Lugol's iodine chromoendoscopy is a technique that is used to identify mucosal abnormalities of the esophagus
EsoCAN assayDevice
Biomarker Test
| Study group | Role | What they receive |
|---|---|---|
| Esophageal Squamous Cell Carcinoma (ESCC) Cases | Experimental | Each 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. Receives: Device: EsophaCap Sponge; Device: EsoCAN assay |
| Non-ESCC, Esophageal squamous dysplasia (ESD) Cases | Experimental | Each 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. Receives: Device: EsophaCap Sponge; Procedure: Chromoendoscopy; Device: EsoCAN assay |
| Non-ESCC, Control Group | Experimental | Each 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. Receives: Device: EsophaCap Sponge; Procedure: Chromoendoscopy; Device: EsoCAN assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
The proportion of participants with both a positive EsoCAN assay result, among patients with histologically-confirmed Esophageal Squamous Dysplasia (ESD). The following equation will be used as a cut point for ESD: [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.
Measured: 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)
The proportion of participants with a negative EsoCAN assay result will be reported. The following equation will be used as a cut point for ESD: [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.
Measured: Up to 38 days
Proportion of study participants who successfully swallow the esophageal sponge device
The success of swallowing the esophageal sponge device will be determined by the clinical team overseeing the EsophaCap' administration and categorized as a dichotomous response of Yes (successful) or No (not successful).
Measured: 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
Adverse events for the lead in cohort with histologically confirmed or suspected ESCC based upon pre-specified clinical criteria will be reported and graded and classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Up to 38 days
Median Acceptability Scores
Participants will be asked to rate their satisfaction with their experience with the EsophaCap sponge procedure after the procedure is complete by selecting a score on a scale with corresponding facial images with scores ranging between 0='Best Experience' (large smile on facial expression) to 10='Worst experience' (crying and frowning facial expression).
Measured: Up to 38 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start16 May 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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 University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 289 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Johns Hopkins University, Muhimbili University of Health and Allied Sciences, CapNostics, LLC
- Responsible party
- Sponsor
- Investigators
- Geoffrey Buckle, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028725
- Sponsor's protocol ID
- 21457
- Other IDs
- 5UH3CA211457-04, NCI-2021-08885
- Status last verified
- Jul 2026
- First submitted
- 25 Aug 2021
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a Novel Strategy for Early Detection of Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05028725
- Acronym / sponsor ID
- 21457
- Keywords
- EsophaCap, Biomarker Detection, Cancer Detection, Chromoendoscopic screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 289 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Johns Hopkins University, Muhimbili University of Health and Allied Sciences, CapNostics, LLC
- Study start
- 16 May 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Aug 2021 (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.
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.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the sensitivity and specificity of a diagnostic strategy combining esophageal sponge sampling with the 'EsophaCap' sponge device with use of the EsoCAN assay, a novel molecular biomarker assay, among patients with histologically-confirmed ESCC cases and controls.
SECONDARY OBJECTIVES:
- To evaluate the sensitivity and specificity of a diagnostic strategy combining esophageal sponge sampling with the 'EsophaCap' sponge device with use of the the EsoCAN assay, among patients with histologically-confirmed ESD and controls.
II. To evaluate the safety and feasibility of 'EsophaCap' a swallowable and retrievable sponge, as a non-invasive strategy for screening and early detection of ESCC and its precursor, ESD, in Tanzania.
EXPLORATORY OBJECTIVES:
- Sensitivity and specificity of esophageal sponge sampling with standard cytological examination among histologically-confirmed ESCC cases and controls.
II. Sensitivity and specificity of esophageal sponge sampling with standard cytological examination among histologically-confirmed ESD cases and controls.
III. To examine methylation levels in new and previously identified genes among patients recruited as suspected ESCC cases who are found to have an alternative diagnosis, with the goal of optimizing the EsoCAN Assay.
OUTLINE:
Each participant will undergo esophageal sponge sampling suing the 'EsophaCap' sponge device. Participants will be on study for up to 38 days.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Esophageal Squamous Cell Carcinoma (ESCC) Cases | Experimental | Device: EsophaCap Sponge, Device: EsoCAN assayEach 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 | Experimental | Device: EsophaCap Sponge, Procedure: Chromoendoscopy, Device: EsoCAN assayEach 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 | Experimental | Device: EsophaCap Sponge, Procedure: Chromoendoscopy, Device: EsoCAN assayEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (43 listed)
- 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.
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 |
|---|---|---|
| EsophaCap SpongeAlso: EsophaCap Sponge Device, EsophaCap Swallowable Sponge deviceNon-invasive strategy to sample esophageal tissue | Device | Esophageal Squamous Cell Carcinoma (ESCC) Cases, Non-ESCC, Control Group, Non-ESCC, Esophageal squamous dysplasia (ESD) Cases |
| ChromoendoscopyAlso: Lugol's iodine chromoendoscopy, Chromoendoscopic screeningLugol's iodine chromoendoscopy is a technique that is used to identify mucosal abnormalities of the esophagus | Procedure or surgery | Non-ESCC, Control Group, Non-ESCC, Esophageal squamous dysplasia (ESD) Cases |
| EsoCAN assayBiomarker Test | Device | Esophageal Squamous Cell Carcinoma (ESCC) Cases, Non-ESCC, Control Group, Non-ESCC, Esophageal squamous dysplasia (ESD) Cases |
Primary outcome
Proportion of True-Positives (sensitivity) detected with the EsoCAN assay after specimen collection using 'EsophaCap' sponge sampling (ESCC cases & controls only)
Time frame: Up to 38 days
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.
Proportion of True-Negatives (specificity) detected with the EsoCAN assay after specimen collection using 'EsophaCap' sponge sampling (ESCC cases & controls only)
Time frame: Up to 38 days
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.
5 secondary outcomes
Proportion of True-Positives (sensitivity) detected with the EsoCAN assay after specimen collection using 'EsophaCap' sponge sampling (ESD cases & controls only)
Time frame: 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)
Time frame: Up to 38 days
Proportion of study participants who successfully swallow the esophageal sponge device
Time frame: 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
Time frame: Up to 38 days
Median Acceptability Scores
Time frame: Up to 38 days
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 23 Jul 2026.
- 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.
Geoffrey Buckle, MD, MPH principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EsophaCap Sponge, Chromoendoscopy and EsoCAN assay in people with Esophageal Squamous Cell Carcinoma and Esophageal Squamous Dysplasia, run by University of California, San Francisco at 2 sites in Tanzania.
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 20 inclusion and 43 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 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tanzania. 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 Geoffrey Buckle, MD, MPH (508-380-9129, geoffrey.buckle@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of True-Positives (sensitivity) detected with the EsoCAN assay after specimen collection using 'EsophaCap' sponge sampling (ESCC cases & controls only) (time frame: Up to 38 days). The study lists 2 primary outcomes in all. 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 23 Jul 2026.