A sponge you swallow could detect esophageal cancer before it spreads

NCT ID NCT05028725

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial tests a new way to spot esophageal cancer early using a swallowable sponge called EsophaCap, which collects cells from the esophagus. A lab test then looks for DNA changes linked to cancer. The study enrolls adults with or suspected of having esophageal cancer, as well as healthy controls, to see how accurate the method is. If it works, it could lead to a simple, low-cost screening tool for high-risk areas.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a swallowable sponge (EsophaCap) and a DNA methylation biomarker test (EsoCAN assay)
What this could lead to
If successful, this could offer a simple, non-invasive screening method to catch esophageal cancer early, potentially saving lives in regions where the disease is common.
What could go wrong
This is an early-stage diagnostic study, not a treatment trial. The test may not be accurate enough in larger populations, and false positives or negatives could limit its usefulness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 289 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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). * 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. Exclusion Criteria: 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) * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Muhimbili National Hospital (MNH)

    RECRUITING

    Dar es Salaam, Mloganzila, Tanzania

  • Muhimbili National Hospital (MNH)

    RECRUITING

    Dar es Salaam, Upganda, Tanzania

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