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Cytosponge™ Feasibility Study in Tanzania (CytoSCCAPE)

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ClinicalTrials.gov Identifier: NCT04090554
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Collaborators:
Kilimanjaro Clinical Research Institute
University of Cambridge
Information provided by (Responsible Party):
International Agency for Research on Cancer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Esophageal Diseases Esophagus SCC Device: Cytosponge™ Not Applicable

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 It is then withdrawn using the suture, and as it does so collects cells from the lining of the oesophagus.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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Healthy community volunteers will be invited to participate in the study , complete and questionnaire and swallow the cytosponge. Participation rates and acceptability of device administration will be assess in this single group.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Esophageal Squamous Cell Carcinoma African Prevention Research (ESCCAPE) Cytosponge™ Feasibility Study
Estimated Study Start Date : September 24, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


  2. 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.


Secondary Outcome Measures :
  1. Prevalence of other benign esophageal pathologies [ Time Frame: 6 months ]
    Prevalence of the presence (yes/no) of oOther benign esophageal pathologies including candidiasis, esophagitis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male and female, based on self-represented gender.
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090554


Contacts
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Contact: Valerie A McCormack, PhD +33 4 72 73 85 66 mccormackv@iarc.fr
Contact: Daniel RS Middleton, PhD +33 472 738 310 middletond@fellows.iarc.fr

Sponsors and Collaborators
International Agency for Research on Cancer
Kilimanjaro Clinical Research Institute
University of Cambridge
Investigators
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Principal Investigator: Valerie A McCormack, PhD International Agency for Research on Cancer
Principal Investigator: Venance Maro, MD Kilimanjaro Clinical Research Institute
  Study Documents (Full-Text)

Documents provided by International Agency for Research on Cancer:
Informed Consent Form  [PDF] March 3, 2019


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Responsible Party: International Agency for Research on Cancer
ClinicalTrials.gov Identifier: NCT04090554     History of Changes
Other Study ID Numbers: TFDA0018/CTR/0012/08
IEC 17-04 ( Other Identifier: International Agency for Research on Cancer )
TFDA0018/CTR/0012/08 ( Other Identifier: Tanzanian Food and Drugs Authority )
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Agency for Research on Cancer:
esophagus
esophageal cancer
cytosponge
Tanzania
Additional relevant MeSH terms:
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Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases