The Cellular Collection Device for Early Detection of Esophageal Squamous Cell Carcinoma
This clinical trial evaluates the effect of the cellular collection device (CCD) for early detection of esophageal squamous cell carcinoma. The CCD is a sponge device that is designed to be swallowed to obtain samples of esophageal tissue. This trial aims to see whether CCD can collect enough tissue to allow for the early detection of esophageal cancer.
Inclusion Criteria
- FOR ESCC CASES (GROUP 1): Male of female >= 18 years of age at screening visit
- FOR ESCC CASES (GROUP 1): Patients are currently seen for clinical care at Muhimbili National Hospital (MNH)-Upanga or at MNH-Mloganzila
- FOR ESCC CASES (GROUP 1): 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: ** Findings on computed tomography (CT) scan ** Findings on barium swallow ** Findings on EGD without biopsy confirmation and/or ** Symptoms of dysphagia and/or odynophagia without an alternative explanation for these symptoms
- FOR ESCC CASES (GROUP 1): Patients must be able to swallow liquid (Ogilvie's score =< 3)
- FOR ESCC CASES (GROUP 1): 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
- FOR ESCC CASES (GROUP 1): Patients must be willing to be contacted either in person or via phone 7-10 days following administration of the CCD sponge device
- FOR ESCC CASES (GROUP 1): Native of Tanzania
- FOR ESCC CASES (GROUP 1): 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
- FOR NON-ESCC CASES (GROUP 2): Male or female >= 18 years of age at screening visit
- FOR NON-ESCC CASES (GROUP 2): Patients are currently seen for clinical care at MNH-Upgana or at MNH-Mloganzila
- FOR NON-ESCC CASES (GROUP 2): Patient is scheduled to undergo EGD for a suspected non-malignant condition with no symptoms concerning for esophageal cancer (i.e. dysphagia or odynophagia)
- FOR NON-ESCC CASES (GROUP 2): Patient must be able to swallow liquid (Ogilvie's score =< 3)
- FOR NON-ESCC CASES (GROUP 2): 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
- FOR NON-ESCC CASES (GROUP 2): Patients must be willing to be contacted either in person or via phone 7-10 days following administration of the CCD sponge device
- FOR NON-ESCC CASES (GROUP 2): Native of Tanzania
- FOR NON-ESCC CASES (GROUP 2): 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
Exclusion Criteria
- FOR ESCC CASES (GROUP 1): Known pregnancy during participation in the study
- FOR ESCC CASES (GROUP 1): 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
- FOR ESCC CASES (GROUP 1): Clinical instability (i.e. hypotension or a recent cardiovascular event)
- FOR ESCC CASES (GROUP 1): Any history of upper gastrointestinal bleeding within the past 3 months (including reported history of hematemesis and/or melena)
- FOR ESCC CASES (GROUP 1): Diagnosis of peptic ulcer disease within the last 3 months
- FOR ESCC CASES (GROUP 1): Known history of esophageal varices
- FOR ESCC CASES (GROUP 1): Patients taking anticoagulation or antiplatelet therapy/medication (warfarin, clopidogrel, aspirin, heparin, or enoxaparin) for high-risk conditions
- FOR ESCC CASES (GROUP 1): Patients with an active extra-esophageal malignancy (not currently in remission)
- FOR ESCC CASES (GROUP 1): Patients with a known history of a non-malignant esophageal stricture
- FOR ESCC CASES (GROUP 1): Patients with esophageal stents currently in place
- FOR ESCC CASES (GROUP 1): Patients with a history of radiation therapy to the head, neck, any part of the gastrointestinal tract (including esophagus) or thorax
- FOR ESCC CASES (GROUP 1): Patients who have previously received chemotherapy in the last 12 months
- FOR ESCC CASES (GROUP 1): Patients with any history of major surgery for esophageal cancer (e.g. esophageal bypass, esophagectomy, etc.)
- FOR ESCC CASES (GROUP 1): Patients who have a known history of or clinical symptoms concerning for trachea-esophageal fistula (aspiration history, severe cough)
- FOR ESCC CASES (GROUP 1): Patients with a known history of small bowel obstruction
- FOR ESCC CASES (GROUP 1): Patients with a history of bleeding complications during esophageal biopsy performed for histological confirmation
- FOR ESCC CASES (GROUP 1): Patients with any history or a head and neck malignancy
- FOR ESCC CASES (GROUP 1): Patients with a known bleeding disorder
- FOR ESCC CASES (GROUP 1): Patients with known thrombocytopenia (less than 50,000 platelets per microliter)
- FOR ESCC CASES (GROUP 1): Individuals who are not permanent residents or natives of Tanzania
- FOR ESCC CASES (GROUP 1): Inability to follow instructions
- FOR ESCC CASES (GROUP 1): Unable to provide informed consent
- FOR NON-ESCC CASES (GROUP 2): Known pregnancy during participation in the study
- FOR NON-ESCC CASES (GROUP 2): 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
- FOR NON-ESCC CASES (GROUP 2): Clinical instability (i.e. hypotension or a recent cardiovascular event)
- FOR NON-ESCC CASES (GROUP 2): Any history of upper gastrointestinal bleeding within the past 3 months (including reported history of hematemesis and/or melena)
- FOR NON-ESCC CASES (GROUP 2): Diagnosis of peptic ulcer disease within the last 3 months
- FOR NON-ESCC CASES (GROUP 2): Known history of esophageal varices
- FOR NON-ESCC CASES (GROUP 2): Patients taking anticoagulation or antiplatelet therapy/medication (warfarin, clopidogrel, aspirin, heparin or enoxaparin) for high-risk conditions
- FOR NON-ESCC CASES (GROUP 2): 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
- FOR NON-ESCC CASES (GROUP 2): Patient with a known history of esophageal strictures disabling passage of the capsule
- FOR NON-ESCC CASES (GROUP 2): Patients with esophageal stents currently in place
- FOR NON-ESCC CASES (GROUP 2): Patients with a history of radiation therapy to the head, neck, any part of the gastrointestinal tract (including esophagus) or thorax
- FOR NON-ESCC CASES (GROUP 2): Patients with a known history of small bowel obstruction
- FOR NON-ESCC CASES (GROUP 2): Patients with a known bleeding disorder
- FOR NON-ESCC CASES (GROUP 2): Patients with known thrombocytopenia (less than 50,000 platelets per microliter)
- FOR NON-ESCC CASES (GROUP 2): Individuals who are not permanent residents or natives of Tanzania
- FOR NON-ESCC CASES (GROUP 2): Allergy to iodine
- FOR NON-ESCC CASES (GROUP 2): Presence of goiter
- FOR NON-ESCC CASES (GROUP 2): Inability to follow instructions
- FOR NON-ESCC CASES (GROUP 2): Unable to provide informed consent
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05028725.
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PRIMARY OBJECTIVE:
I. To evaluate the sensitivity and specificity of a diagnostic strategy combining esophageal sponge sampling using the CCD, with use of the EsoCAN assay, a novel biomarker assay, among patients with histologically-confirmed esophageal squamous cell carcinoma (ESCC) and controls.
SECONDARY OBJECTIVES:
I. To evaluate the sensitivity and specificity of a diagnostic strategy combining esophageal sponge sampling with use of the EsoCAN assay among patients with histologically-confirmed esophageal squamous dysplasia (ESD) and controls.
II. To evaluate the safety and feasibility of CCD, 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:
I. To evaluate the sensitivity and specificity of a diagnostic strategy combining esophageal sponge sampling using the CCD with standard cytology, among patients with histologically-confirmed ESCC and controls.
II. To evaluate the sensitivity and specificity of a diagnostic strategy combining esophageal sponge sampling using the CCD with standard cytology, among patients with histologically-confirmed ESD 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:
Patients undergo esophageal cell sampling with CCD sponge device over 10 minutes. Patients may undergo standard of care esophagogastroduodenoscopy (EGD) with Lugol's iodine before or after esophageal cell sampling.
After completion of study, patients are followed at 7-10 days.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorGeoffrey Buckle
- Primary ID21457
- Secondary IDsNCI-2021-08885, 20-32963
- ClinicalTrials.gov IDNCT05028725