Cytosponge™ Feasibility Study in Tanzania

NCT04090554 | Completed

• 2 other identifiers: TFDA0018/CTR/0012/08IEC 17-04
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Diseases; Esophagus SCC

Keywords

esophagus; esophageal cancer; cytosponge; Tanzania

Outcome Measures

Primary Outcomes (2)

• Prevalence of any-grade of esophageal dysplasia

  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

  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 Outcomes (1)

• Prevalence of other benign esophageal pathologies

  6 months

Study Arms (1)

Cytosponge™

OTHER

Single intervention arm of feasibility study

Device: Cytosponge™

Interventions

Cytosponge™ DEVICE

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 It is then withdrawn using the suture, and as it does so collects cells from the lining of the oesophagus.

Cytosponge™

Eligibility Criteria

• Age: 30 Years+
• Gender Eligibility Details: Male and female, based on self-represented gender.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Agency for Research on Cancer: lead
• Kilimanjaro Clinical Research Institute: collaborator
• University of Cambridge: collaborator

Study Sites (1)

Majengo Unit, Kilimanjaro Clinical Research Institute

Moshi, Tanzania

Location

Related Publications (1)

• Middleton DRS, Mmbaga BT, O'Donovan M, Abedi-Ardekani B, Debiram-Beecham I, Nyakunga-Maro G, Maro V, Bromwich M, Daudi A, Ngowi T, Minde R, Claver J, Mremi A, Mwasamwaja A, Schuz J, Fitzgerald RC, McCormack V. Minimally invasive esophageal sponge cytology sampling is feasible in a Tanzanian community setting. Int J Cancer. 2021 Mar 1;148(5):1208-1218. doi: 10.1002/ijc.33366. Epub 2020 Nov 21.

  PMID: 33128785 DERIVED

MeSH Terms

Conditions

Esophageal Diseases; Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms

Study Officials

• Valerie A McCormack, PhD

  International Agency for Research on Cancer

  PRINCIPAL INVESTIGATOR

• Venance Maro, MD

  Kilimanjaro Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 16, 2019
• Study Start: September 24, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 30, 2020
• Last Updated: August 25, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)