Trial Outcomes & Findings for Esophageal Cytology With FISH in Detecting Esophageal Cancer (NCT NCT02100189)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

At the time of sponge cytology and EGD

Results posted on

2017-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Esophageal Cell Harvesting Procedure 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.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Esophageal Cytology With FISH in Detecting Esophageal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Esophageal Cell Harvesting Procedure n=50 Participants 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.
Age, Continuous	64 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants
Body Mass Index, average	29.5 kg/m^2 STANDARD_DEVIATION 7.66 • n=5 Participants
Number of participants with history of GERD	38 Participants n=5 Participants
Number of participants with history of Barrett's Esophagus	28 Participants n=5 Participants
Number of participants with a history of PPI use	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: At the time of sponge cytology and EGD

Population: Analysis was per protocol

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.

Outcome measures

Outcome measures
Measure	Esophageal Cell Harvesting Procedure n=50 Participants 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.
Sensitivity of Sponge Cytology Using FISH	13.3 percentage of cases among positive tests Interval 3.76 to 30.72

PRIMARY outcome

Timeframe: At the time of sponge cytology and EGD

Population: Per protocol

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.

Outcome measures

Outcome measures
Measure	Esophageal Cell Harvesting Procedure n=50 Participants 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.
Specificity of Sponge Cytology Using FISH	94.7 Percentage of non-cases among neg tests Interval 73.97 to 99.87

SECONDARY outcome

Timeframe: At the time of sponge cytology procedure

Population: Intent to Treat (ITT)

Descriptive statistics will be used to summarize all adverse events associated with FISH sponge cytology test.

Outcome measures

Outcome measures
Measure	Esophageal Cell Harvesting Procedure n=50 Participants 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.
Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	16 adverse events

SECONDARY outcome

Timeframe: After completion of FISH and EGD

Population: Intent to Treat (ITT)

Tolerability is defined as the patient's willingness to repeat procedure.

Outcome measures

Outcome measures
Measure	Esophageal Cell Harvesting Procedure n=50 Participants 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.
Tolerability of FISH Spongy Cytology	100 percentage of subjects tolerating test

Adverse Events

Esophageal Cell Harvesting Procedure

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Esophageal Cell Harvesting Procedure n=50 participants at risk 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.
Gastrointestinal disorders Gagging / Discomfort	28.0% 14/50 • Number of events 14 • Adverse Events were collected on patients from time of consent to completion of cell harvesting procedure, up to 24 hours.
Gastrointestinal disorders Emesis	4.0% 2/50 • Number of events 2 • Adverse Events were collected on patients from time of consent to completion of cell harvesting procedure, up to 24 hours.

Additional Information

John Hunter, MD

OHSU

Phone: 503-494-4937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place