Barrett EsophagusNCT02890979
Swallowable Sponge Cell Sampling Device and Next Generation Sequencing in Detecting Esophageal Cancer in Patients With Low or High Grade Dysplasia, Barrett Esophagus, or Gastroesophageal Reflux Disease
A study testing Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis and Quality-of-Life Assessment in people with Barrett Esophagus and Dysplasia, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This pilot clinical trial studies how well a swallowable sponge cell sampling device and next generation sequencing work in detecting esophageal cancer in patients with low or high grade dysplasia, Barrett esophagus, or gastroesophageal reflux disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus, Dysplasia, Esophageal Adenocarcinoma
- What is being tested?
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis and Quality-of-Life Assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2016to 10 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent document
- Patients must be scheduled for a procedure capable of providing a definitive pathologic diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either upper endoscopy or surgical esophagectomy
- One of the following inclusion criteria must be true for patient to be eligible for enrollment:
- Subjects with known esophageal cancer (adenocarcinoma or squamous cell carcinoma)
- Subjects with a history of low or high grade dysplasia
- Subjects with risk factors for esophageal malignancy including Barrett?s esophagus and gastroesophageal reflux disease (GERD)
Who cannot join
- Subjects that are unable to swallow a tablet/pill
- Subjects with completely obstructing esophageal cancer
- Subjects with known or suspected esophageal varices
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Any condition which, in the opinion of the investigator precludes the patient from completion of the study procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Next Generation Sequencing of Esophageal Cytology for the Early Detection of Esophageal Cancer
This pilot clinical trial studies how well a swallowable sponge cell sampling device and next generation sequencing work in detecting esophageal cancer in patients with low or high grade dysplasia, Barrett esophagus, or gastroesophageal reflux disease. Checking biomarkers in abnormal esophageal cells using a swallowable sponge cell sampling device and next generation sequencing may improve diagnosis and treatment of esophageal cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the sensitivity and specificity of next generation sequencing for the detection of esophageal cancer from esophageal sponge cytology specimens.
SECONDARY OBJECTIVES:
- Determine the ability of next generation gene sequencing (NGS) of esophageal sponge samples to collect an adequate sample to detect mutations that are present in the underlying tissue.
II. Determine the cost associated with esophageal cytology with next generation genome sequencing as a screening tool.
III. Continue to collect safety and tolerability data related to the use of the Oesotest esophageal sponge.
IV. Determine the limitations of esophageal sponge cytology and future needs to improve this technique.
- Use the data collected to design a larger screening trial to determine the ability of esophageal cytology with next generation sequencing to screen for esophageal cancer in the general population.
OUTLINE:
Patients undergo cytology specimen collection procedure using a swallowable sponge cell sampling device.
- Conditions
- Barrett Esophagus, Dysplasia, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Gastroesophageal Reflux Disease, Metaplasia
- Being tested
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Swallowable Sponge Cell Sampling Device
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma, Gastroesophageal Reflux, Metaplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Undergo cytology specimen collection procedure using a swallowable sponge cell sampling device
Laboratory Biomarker AnalysisOther
Correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Swallowable Sponge Cell Sampling DeviceDevice
Also called Swallowable Sponge, Swallowable Sponge Device
Undergo cytology specimen collection procedure using a swallowable sponge cell sampling device
| Study group | Role | What they receive |
|---|---|---|
| Screening (cytology collection) | Experimental | Patients undergo cytology specimen collection procedure using a swallowable sponge cell sampling device. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Device: Swallowable Sponge Cell Sampling Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of gene mutations using next generation sequencing (NGS)
Will calculate the concordance of the gene mutations identified from the sponge sample to those identified from the tissue biopsy (control).
Measured: Up to 2 years
Secondary outcomes (1)
Sensitivity and specificity of the NGS probes to detect underlying esophageal dysplasia or cancer
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start3 Aug 2016
- Primary completion10 Oct 2017
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- James Dolan, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890979
- Sponsor's protocol ID
- STUDY00015499
- Other IDs
- NCI-2016-01318, STUDY00015499
- Status last verified
- Nov 2020
- First submitted
- 1 Sep 2016
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next Generation Sequencing of Esophageal Cytology for the Early Detection of Esophageal Cancer
- ClinicalTrials.gov ID
- NCT02890979
- Acronym / sponsor ID
- STUDY00015499
- Conditions
- Barrett Esophagus, Dysplasia, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Gastroesophageal Reflux Disease, Metaplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 3 Aug 2016 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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.
This pilot clinical trial studies how well a swallowable sponge cell sampling device and next generation sequencing work in detecting esophageal cancer in patients with low or high grade dysplasia, Barrett esophagus, or gastroesophageal reflux disease. Checking biomarkers in abnormal esophageal cells using a swallowable sponge cell sampling device and next generation sequencing may improve diagnosis and treatment of esophageal cancer.
Detailed description
PRIMARY OBJECTIVES:
- Determine the sensitivity and specificity of next generation sequencing for the detection of esophageal cancer from esophageal sponge cytology specimens.
SECONDARY OBJECTIVES:
- Determine the ability of next generation gene sequencing (NGS) of esophageal sponge samples to collect an adequate sample to detect mutations that are present in the underlying tissue.
II. Determine the cost associated with esophageal cytology with next generation genome sequencing as a screening tool.
III. Continue to collect safety and tolerability data related to the use of the Oesotest esophageal sponge.
IV. Determine the limitations of esophageal sponge cytology and future needs to improve this technique.
- Use the data collected to design a larger screening trial to determine the ability of esophageal cytology with next generation sequencing to screen for esophageal cancer in the general population.
OUTLINE:
Patients undergo cytology specimen collection procedure using a swallowable sponge cell sampling device.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (cytology collection) | Experimental | Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Device: Swallowable Sponge Cell Sampling DevicePatients undergo cytology specimen collection procedure using a swallowable sponge cell sampling device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to understand and the willingness to sign a written informed consent document
- Patients must be scheduled for a procedure capable of providing a definitive pathologic diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either upper endoscopy or surgical esophagectomy
- One of the following inclusion criteria must be true for patient to be eligible for enrollment:
- Subjects with known esophageal cancer (adenocarcinoma or squamous cell carcinoma)
- Subjects with a history of low or high grade dysplasia
Key exclusion criteria (5 listed)
- Subjects that are unable to swallow a tablet/pill
- Subjects with completely obstructing esophageal cancer
- Subjects with known or suspected esophageal varices
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Any condition which, in the opinion of the investigator precludes the patient from completion of the study procedure
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 |
|---|---|---|
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingUndergo cytology specimen collection procedure using a swallowable sponge cell sampling device | Other | Screening (cytology collection) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Screening (cytology collection) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Screening (cytology collection) |
| Swallowable Sponge Cell Sampling DeviceAlso: Swallowable Sponge, Swallowable Sponge DeviceUndergo cytology specimen collection procedure using a swallowable sponge cell sampling device | Device | Screening (cytology collection) |
Primary outcome
Detection of gene mutations using next generation sequencing (NGS)
Time frame: Up to 2 years
Will calculate the concordance of the gene mutations identified from the sponge sample to those identified from the tissue biopsy (control).
1 secondary outcome
Sensitivity and specificity of the NGS probes to detect underlying esophageal dysplasia or cancer
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
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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. This study is not recruiting at the moment.
James Dolan principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis and Quality-of-Life Assessment in people with Barrett Esophagus and Dysplasia, run by OHSU Knight Cancer Institute at 1 site in United States.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of gene mutations using next generation sequencing (NGS) (time frame: Up to 2 years). 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 25 Nov 2020.