Cytosponge™ Feasibility Study in Tanzania (CytoSCCAPE)

August 24, 2021 updated by: International Agency for Research on Cancer

Esophageal Squamous Cell Carcinoma African Prevention Research (ESCCAPE) Cytosponge™ Feasibility Study

A Tanzanian pilot study to test the feasibility of using the Cytosponge™ device - a less-invasive endoscopy alternative - for research on esophageal squamous cell carcinoma in African settings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Cytosponge™ consists of a spherical mesh enclosed in a gelatine capsule and attached to a string. The capsule is swallowed with the use of water and allowed to reach the stomach while remaining attached to the suture which is held onto by the patient or nurse (and which is affixed to a card preventing inadvertent swallowing of the suture). In the stomach the capsule is left for up to 5 minutes where it dissolves allowing the sponge to expand to its full size. It is then withdrawn using the suture, and as it does so collects cells from the lining of the oesophagus. After retrieval the Cytosponge™ containing the cytological specimen placed in preservative fluid. The typical cell yield of the procedure is 250,000. These cells are used to prepare a clot which is fixed with formalin and embedded in paraffin for sectioning and slide preparation. Slides are then examined under a microscope for pathological diagnosis and characterisation. This device was approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in 2008 and is a Class 1 device according to European Medical Devices 93/42/EEC as implemented in the United Kingdom by The Medical Devices Regulations 2002 (SI No 618).

Healthy adult (>30 years) volunteers will be recruited during routine visits to the Majengo Healthcare Centre in Moshi, Tanzania where they will be informed of the study and invited to participate. Their participation will then involve the following:

  • Completing a short lifestyle questionnaire.
  • Swallowing the Cytosponge™ device to collect cells from their oesophagus.
  • Being contacted by telephone 7-days post procedure to assess acceptability.

The following endpoints will be investigated:

Core:

  • Response rate of participants invited to swallow device.
  • Proportion of participants able to swallow the device within three attempts and number of attempts taken (frequency distribution of 1, 2 and 3 attempts).
  • Post-swallow acceptability of device as per a previously employed satisfaction score (graded 0-10)
  • Proportion of collected sponges successfully processed into paraffin blocks.
  • Prevalence of ESD as determined by examination by a trained pathologist.
  • Prevalence of benign oesophageal pathologies (inflammation, candidiasis, eosinophilic oesophagitis).

Extended (subject to future funding):

  • Prevalence of positivity for antibodies against chemical exposures and proliferation markers.
  • DNA yield from cells collected from the device.
  • DNA methylation profiles.
  • Genetic mutations in candidate cancer-relevant gene panel.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Moshi, Tanzania
        • Majengo Unit, Kilimanjaro Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 30 years or older.
  • Resident of Kilimanjaro Region for 10 years or more.

Exclusion Criteria:

  • Eaten or drank within the last 4 hours.
  • Known current pregnancy.
  • Objection to CytoSCCAPE data collection.
  • Symptoms of dysphagia (difficulty swallowing).
  • Recorded history of oropharyngeal, esophageal or gastric cancer
  • Received prior surgical intervention to the esophagus.
  • Esophageal varices, stricture or requiring esophageal dilation.
  • Recorded cirrhosis of the liver.
  • Swallowing difficulty due to cerebrovascular accident or neurological disorder.
  • Recent history of vomiting blood.
  • Recent use of anticoagulation therapy/medication.
  • Myocardial infarction or any cardiac event within the last 6 months.
  • Lacking capacity to provide informed consent.
  • Unwilling to swallow beef gelatine capsule due to dietary preferences.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cytosponge™
Single intervention arm of feasibility study
Device: Cytosponge™
The device consists of a spherical mesh enclosed in a gelatine capsule and attached to a string. The capsule is swallowed and allowed to reach the stomach . In the stomach the capsule is left for up to 5 minutes where it dissolves allowing the sponge to expand to its full size. It is then withdrawn using the suture, and as it does so collects cells from the lining of the oesophagus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of any-grade of esophageal dysplasia
Time Frame: 6 months

Any grade (low, moderate or high) of dysplasia. The Three-tier grading scheme will be used:

grade 1 (low) well-differentiated; grade 2 (intermediate) for moderately differentiated; grade 3 (high) for poorly differentiated.
6 months
Distribution of acceptability scores
Time Frame: After cytosponge swallow
Device satisfaction rating assessed on a visual analogue scale from 1 to 10, representing the best and worst satisfaction levels, respectively, and a cartoon face was used to assist interpretation of this scale.
After cytosponge swallow

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of other benign esophageal pathologies
Time Frame: 6 months
Prevalence of the presence (yes/no) of oOther benign esophageal pathologies including candidiasis, esophagitis.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Agency for Research on Cancer

Collaborators

University of Cambridge
Kilimanjaro Clinical Research Institute

Investigators

  • Principal Investigator: Valerie A McCormack, PhD, International Agency for Research on Cancer
  • Principal Investigator: Venance Maro, MD, Kilimanjaro Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2019

Primary Completion (Actual)

December 20, 2019

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

September 10, 2019

First Submitted That Met QC Criteria

September 12, 2019

First Posted (Actual)

September 16, 2019

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TFDA0018/CTR/0012/08 (Other Identifier: Tanzanian Food and Drugs Authority)
  • IEC 17-04 (Other Identifier: International Agency for Research on Cancer)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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