Squamous Cell CancerEarly Phase 1NCT01384708
Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell Cancer
A Early Phase 1 study testing proflavine in people with Squamous Cell Cancer, run by Anandasabapathy, Sharmila, M.D. at 1 site in United States.
Trial summary
The overall objective of this study is to determine whether high-resolution imaging of the esophagus during routine diagnostic upper endoscopy can assist clinicians in detecting and discriminating dysplastic (precancerous) areas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Cancer
- What is being tested?
- proflavine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Oct 2013
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- known or suspected squamous cell neoplasia
- 18 years or older
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center
New York, New York, 10029
About this study
The overall objective of this study is to determine whether high-resolution imaging of the esophagus during routine diagnostic upper endoscopy can assist clinicians in detecting and discriminating dysplastic (precancerous) areas. This high-resolution microendoscope (HRME) was developed by our collaborators at Rice University and provides > 1000x magnified images of the esophageal mucosa. The purpose of this study is to determine whether this device can be used to enhance the diagnostic accuracy of routine endoscopic screening for squamous cell cancer of the esophagus.
- Conditions
- Squamous Cell Cancer
- Being tested
- proflavine
- Keywords
- squamous cell cancer, squamous cell neoplasia
- Medical subject headings
- Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proflavineDrug
Also called Proflavine hemisulfate
1-10 ml of proflavine (derived form dissolving 10mg proflavine hemisulfate USP in 100 ml sterile water)
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | imaging with proflavine Receives: Drug: proflavine |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine whether or not tissue is neoplastic or non-neoplastic
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startAug 2010
- Primary completionOct 2013
- Study completionOct 2013
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 Squamous Cell CancerStudies 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
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anandasabapathy, Sharmila, M.D.
- Collaborators
- William Marsh Rice University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384708
- Sponsor's protocol ID
- GCO# 10-0982
- Status last verified
- Mar 2014
- First submitted
- 28 Jun 2011
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Protano MA, Xu H, Wang G, Polydorides AD, Dawsey SM, Cui J, Xue L, Zhang F, Quang T, Pierce MC, Shin D, Schwarz RA, Bhutani MS, Lee M, Parikh N, Hur C, Xu W, Moshier E, Godbold J, Mitcham J, Hudson C, Richards-Kortum RR, Anandasabapathy S. Low-Cost High-Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia: An International Trial. Gastroenterology. 2015 Aug;149(2):321-329. doi: 10.1053/j.gastro.2015.04.055. Epub 2015 May 14.
PubMed 25980753
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell Cancer
- ClinicalTrials.gov ID
- NCT01384708
- Acronym / sponsor ID
- GCO# 10-0982
- Conditions
- Squamous Cell Cancer
- Keywords
- squamous cell cancer, squamous cell neoplasia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Anandasabapathy, Sharmila, M.D.
- Collaborators
- William Marsh Rice University
- Study start
- Aug 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 29 Jun 2011 (estimated)
- 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.
The overall objective of this study is to determine whether high-resolution imaging of the esophagus during routine diagnostic upper endoscopy can assist clinicians in detecting and discriminating dysplastic (precancerous) areas. This high-resolution microendoscope (HRME) was developed by our collaborators at Rice University and provides > 1000x magnified images of the esophageal mucosa. The purpose of this study is to determine whether this device can be used to enhance the diagnostic accuracy of routine endoscopic screening for squamous cell cancer of the esophagus.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: proflavineimaging with proflavine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- known or suspected squamous cell neoplasia
- 18 years or older
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| proflavineAlso: Proflavine hemisulfate1-10 ml of proflavine (derived form dissolving 10mg proflavine hemisulfate USP in 100 ml sterile water) | Drug | treatment |
Primary outcome
to determine whether or not tissue is neoplastic or non-neoplastic
Time frame: 1 day
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 11 Jan 2016.
- Derived from this study: PubMed 25980753Protano MA, Xu H, Wang G, Polydorides AD, Dawsey SM, Cui J, Xue L, Zhang F, Quang T, Pierce MC, Shin D, Schwarz RA, Bhutani MS, Lee M, Parikh N, Hur C, Xu W, Moshier E, Godbold J, Mitcham J, Hudson C, Richards-Kortum RR, Anandasabapathy S. Low-Cost High-Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia: An International Trial. Gastroenterology. 2015 Aug;149(2):321-329. doi: 10.1053/j.gastro.2015.04.055. Epub 2015 May 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing proflavine in people with Squamous Cell Cancer, run by Anandasabapathy, Sharmila, M.D. at 1 site in United States.
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 0 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 11 Jan 2016. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
to determine whether or not tissue is neoplastic or non-neoplastic (time frame: 1 day). 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 NCT01384708, 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 11 Jan 2016.