DysphagiaNCT02100189

Esophageal Cytology With FISH in Detecting Esophageal Cancer

A study testing Cytology Specimen Collection Procedure, Esophagogastroduodenoscopy and Laboratory Biomarker Analysis in people with Dysphagia and Dysplasia, run by OHSU Knight Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dysphagia, Dysplasia, Esophageal Adenocarcinoma
What is being tested?: Cytology Specimen Collection Procedure, Esophagogastroduodenoscopy and Laboratory Biomarker Analysis
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Feb 2014to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Subjects with known esophageal cancer diagnosed by previous endoscopy
Adenocarcinoma
Squamous cell carcinoma
Patients determined to be at risk for esophageal cancer:
Subjects with a history of Barrett's esophagus
Subjects with a history of low or high grade dysplasia

Show all 14Show fewer

Subjects with a history of gastroesophageal reflux disease (GERD)
Subjects with a history of esophagitis
Subjects with symptoms of esophageal cancer (EC) referred for endoscopy (new onset dysphagia, weight loss, etc)
Patients must be scheduled for a procedure capable of providing a definitive pathological diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either:
Upper endoscopy
Surgical esophagectomy
Subjects with Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (Karnofsky >= 30%) will be included
Ability to understand and the willingness to sign a written informed consent document

Who cannot join

Subjects with severe, symptomatic dysphagia (unable to pass solids)
Subjects that are unable to swallow a tablet/pill for any reason
Subjects with a previous esophagectomy
Subjects with esophageal varices
Subjects unable to provide consent
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

Trial locations and contacts

1 site in 1 country.

United States1 site

OHSU Knight Cancer Institute
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Esophageal Cancer (10030139, 10066354) Screening With FISH in Esophageal Cytology

This clinical trial studies whether esophageal cytology plus fluorescence in situ hybridization (FISH) is equal to or better than esophago-gastro-duodenoscopy (EGD) or upper endoscopy for the early detection of esophageal cancer. Genes are the units of deoxyribonucleic acid (DNA) the chemical structure carrying genetic information that determine many human characteristics. Certain genes in cancer cells may determine how the tumor grows or spreads and how it may respond to different drugs. Part of this study is to test those genes in esophageal cells using FISH.

Read the detailed description

PRIMARY OBJECTIVES:

Determine if sponge cytology with FISH is a reliable screening tool for esophageal dysplasia/cancer, and determine its sensitivity and specificity, compared to the gold standard procedure (upper endoscopy).

SECONDARY OBJECTIVES:

Determine if the cytology screening with FISH biomarkers is more cost effective than upper endoscopy for the screening of esophageal cancer and the surveillance of esophageal metaplasia and dysplasia.

II. Determine the limitations and future needs to improve this technique.

OUTLINE:

Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.

Conditions: Dysphagia, Dysplasia, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Esophagitis, Gastroesophageal Reflux Disease
Being tested: Cytology Specimen Collection Procedure, Esophagogastroduodenoscopy, Laboratory Biomarker Analysis
Medical subject headings: Deglutition Disorders, Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma, Esophagitis, Gastroesophageal Reflux, Weight Loss

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 esophageal cytology collection
EsophagogastroduodenoscopyProcedure or surgery
Also called EGD
Undergo standard EGD or endoscopy
Laboratory Biomarker AnalysisOther
Correlative studies

Study groups in NCT02100189
Study group	Role	What they receive
Screening (esophageal cytology, FISH)	Experimental	Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy. Receives: Other: Cytology Specimen Collection Procedure; Procedure: Esophagogastroduodenoscopy; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity of Sponge Cytology Using FISH
All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.
Measured: At the time of sponge cytology and EGD
Specificity of Sponge Cytology Using FISH
All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.
Measured: At the time of sponge cytology and EGD

Secondary outcomes (2)

Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Descriptive statistics will be used to summarize all adverse events associated with FISH sponge cytology test.
Measured: At the time of sponge cytology procedure
Tolerability of FISH Spongy Cytology
Tolerability is defined as the patient's willingness to repeat procedure.
Measured: After completion of FISH and EGD

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Dec 2015

First posted31 Mar 2014 (estimated)
Study startFeb 2014
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DysphagiaStudies of the same condition, open and under way.
More trials run by OHSU Knight Cancer InstituteThe 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: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02100189
Sponsor's protocol ID: IRB00009213
Other IDs: NCI-2014-00384, IRB00009213, P30CA069533
Status last verified: May 2017
First submitted: 28 Feb 2014
Last updated: 11 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
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The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
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taVNS in Infants Severe Dysphagia
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Active, not recruitingObservational study
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All Dysphagia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Esophageal Cancer (10030139, 10066354) Screening With FISH in Esophageal Cytology
ClinicalTrials.gov ID: NCT02100189
Acronym / sponsor ID: IRB00009213
Conditions: Dysphagia, Dysplasia, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Esophagitis, Gastroesophageal Reflux Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: OHSU Knight Cancer InstituteUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Feb 2014
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 31 Mar 2014 (estimated)
Results: Posted 13 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

Determine if sponge cytology with FISH is a reliable screening tool for esophageal dysplasia/cancer, and determine its sensitivity and specificity, compared to the gold standard procedure (upper endoscopy).

SECONDARY OBJECTIVES:

Determine if the cytology screening with FISH biomarkers is more cost effective than upper endoscopy for the screening of esophageal cancer and the surveillance of esophageal metaplasia and dysplasia.

II. Determine the limitations and future needs to improve this technique.

OUTLINE:

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Screening (esophageal cytology, FISH)	Experimental	Other: Cytology Specimen Collection Procedure, Procedure: Esophagogastroduodenoscopy, Other: Laboratory Biomarker AnalysisParticipants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Subjects with known esophageal cancer diagnosed by previous endoscopy
Patients determined to be at risk for esophageal cancer:
Patients must be scheduled for a procedure capable of providing a definitive pathological diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either:
Subjects with Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (Karnofsky >= 30%) will be included
Ability to understand and the willingness to sign a written informed consent document

Key exclusion criteria (6 listed)

Subjects with severe, symptomatic dysphagia (unable to pass solids)
Subjects that are unable to swallow a tablet/pill for any reason
Subjects with a previous esophagectomy
Subjects with esophageal varices
Subjects unable to provide consent

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 esophageal cytology collection	Other	Screening (esophageal cytology, FISH)
EsophagogastroduodenoscopyAlso: EGDUndergo standard EGD or endoscopy	Procedure or surgery	Screening (esophageal cytology, FISH)
Laboratory Biomarker AnalysisCorrelative studies	Other	Screening (esophageal cytology, FISH)

Primary outcome

Sensitivity of Sponge Cytology Using FISH
Time frame: At the time of sponge cytology and EGD
All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.
Specificity of Sponge Cytology Using FISH
Time frame: At the time of sponge cytology and EGD
All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.

2 secondary outcomes

Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time frame: At the time of sponge cytology procedure
Tolerability of FISH Spongy Cytology
Time frame: After completion of FISH and EGD

Results and safety

Results posted to the registry on 13 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Esophageal Cell Harvesting Procedure	50	50

Primary outcome: Sensitivity of Sponge Cytology Using FISH

Time frame: At the time of sponge cytology and EGD. Number (95% Confidence Interval). Unit: percentage of cases among positive tests

Measure	Esophageal Cell Harvesting Procedure n = 50
Value	13.3 (3.76 to 30.72)

Esophageal Cell Harvesting Procedure: Sensitivity: 13.30 (95% CI 3.76 to 30.72), Sensitivity

Population analysed: Analysis was per protocol

Primary outcome: Specificity of Sponge Cytology Using FISH

Time frame: At the time of sponge cytology and EGD. Number (95% Confidence Interval). Unit: Percentage of non-cases among neg tests

Measure	Esophageal Cell Harvesting Procedure n = 50
Value	94.7 (73.97 to 99.87)

Esophageal Cell Harvesting Procedure: Specificity: 94.7 (95% CI 73.97 to 99.87), Specificity

Population analysed: Per protocol

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected on patients from time of consent to completion of cell harvesting procedure, up to 24 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Esophageal Cell Harvesting Procedure	0 of 50 (0%)	16 of 50 (32%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dysphagia

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
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Recruiting
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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.

John Hunter 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?

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 14 inclusion and 6 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 11 May 2017. 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?

Yes. Results are posted in the registry (first posted 13 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Sensitivity of Sponge Cytology Using FISH (time frame: At the time of sponge cytology and EGD). 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?

On the ClinicalTrials.gov record for NCT02100189.

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 11 May 2017.