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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 January 2021 |
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Main ID: |
NCT02029937 |
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Date of registration:
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17/12/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia
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Scientific title:
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High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia: A Randomized, Multicenter Trial of Accuracy, Yield, and Clinical Impact |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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1300 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02029937 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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China
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United States
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Contacts
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Name:
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Madeleine Allman, MPH |
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Address:
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Telephone:
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713-798-7585 |
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Email:
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allman@bcm.edu |
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Affiliation:
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Name:
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Sharmila Anandasabapathy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Baylor College of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
All inclusive outpatients undergoing routine (standard of care) Lugol's chromoendoscopic
evaluation for suspected or known squamous cell neoplasia will be enrolled as well as any
outgoing patients referred to the clinic with any prior history of squamous cell dysplasia
and/or neoplasia will also be considered eligible as they will serve as study population
for the surveillance group.
Exclusion Criteria:
- Allergy or prior reaction to the fluorescent contrast agent proflavine
- Patients who are unable to give informed consent
- Known advanced squamous cell carcinoma of the distal esophagus, or dyplastic/suspected
malignant esophageal lesion greater than or equal to 2cm in size not amenable to
endoscopic therapy
- Patient unable to undergo routine endoscopy with biopsy:
- women who are pregnant or breastfeeding
- prothrombin time greater than 50% of control; PTT greater than 50 sec, or INR greater
than 2.0
- inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or
other significant medical issues
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Suspected or Known Squamous Cell Neoplasia
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Prior History of Squamous Cell Dysplasia and /or Neoplasia
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Intervention(s)
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Drug: Proflavine, high resolution imaging
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Primary Outcome(s)
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Comparison of the efficiency of HRME+Lugol's chromoendoscopy (HRME+LC) to that of Lugol's chromoendoscopy alone (LC) for the diagnosis of esophageal squamous cell neoplasia.
[Time Frame: 1 day]
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Secondary Outcome(s)
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Determination whether HRME changes the decision to perform endoscopic therapy or perform a mucosal biopsy
[Time Frame: 1 day]
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Secondary ID(s)
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GCO 13-0396
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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