Esophageal DiseasesCytoSCCAPENCT04090554
Cytosponge™ Feasibility Study in Tanzania
A study testing Cytosponge™ in people with Esophageal Diseases and Esophagus SCC, run by International Agency for Research on Cancer at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Esophageal Diseases, Esophagus SCC
- What is being tested?
- Cytosponge™
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTanzania
- Study dates
- 24 Sep 2019to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 30 years or older.
- Resident of Kilimanjaro Region for 10 years or more.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophageal Diseases, Esophagus SCC
- Being tested
- Cytosponge™
- Keywords
- esophagus, esophageal cancer, cytosponge, Tanzania
- Medical subject headings
- Esophageal Diseases, Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cytosponge™ | Other | Single intervention arm of feasibility study Receives: Device: Cytosponge™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After cytosponge swallow
Secondary outcomes (1)
Prevalence of other benign esophageal pathologies
Prevalence of the presence (yes/no) of oOther benign esophageal pathologies including candidiasis, esophagitis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start24 Sep 2019
- Primary completion20 Dec 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal DiseasesStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- Kilimanjaro Clinical Research Institute, University of Cambridge
- Responsible party
- Sponsor
- Investigators
- Valerie A McCormack, PhD, Principal investigator, International Agency for Research on CancerVenance Maro, MD, Principal investigator, Kilimanjaro Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090554
- Sponsor's protocol ID
- TFDA0018/CTR/0012/08
- Other IDs
- IEC 17-04, TFDA0018/CTR/0012/08
- Acronym
- CytoSCCAPE
- Status last verified
- Feb 2020
- First submitted
- 10 Sep 2019
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33128785
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Squamous Cell Carcinoma African Prevention Research (ESCCAPE) Cytosponge™ Feasibility Study
- ClinicalTrials.gov ID
- NCT04090554
- Acronym / sponsor ID
- CytoSCCAPE / TFDA0018/CTR/0012/08
- Conditions
- Esophageal Diseases, Esophagus SCC
- Keywords
- esophagus, esophageal cancer, cytosponge, Tanzania
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Collaborators
- Kilimanjaro Clinical Research Institute, University of Cambridge
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cytosponge™ | Other | Device: Cytosponge™Single intervention arm of feasibility study |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 30 years or older.
- Resident of Kilimanjaro Region for 10 years or more.
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| 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. | Device | Cytosponge™ |
Primary outcome
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.
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.
1 secondary outcome
Prevalence of other benign esophageal pathologies
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 33128785Middleton 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.
- Individual participant dataSharing planned: No
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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.
Valerie A McCormack, PhD principal investigator
International Agency for Research on Cancer
Venance Maro, MD principal investigator
Kilimanjaro Clinical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytosponge™ in people with Esophageal Diseases and Esophagus SCC, run by International Agency for Research on Cancer at 1 site in Tanzania.
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 2 inclusion and 14 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 25 Aug 2021. 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 Tanzania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of any-grade of esophageal dysplasia (time frame: 6 months). 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 NCT04090554, which also lists 1 linked publication.
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 25 Aug 2021.