Colorectal CancerEarly Phase 1NCT03070613
Investigating the Use of Fluorescent Lectins to Identify Dysplasia and Cancer During Endoscopy and Surgery
A Early Phase 1 study testing Fluorescent Lectin Application in people with Colorectal Cancer and Colorectal Neoplasms, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
This is a feasibility study investigating the use of a fluorescently conjugated lectin to identify colorectal dysplasia and cancer during colonoscopy and surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Polyp
- What is being tested?
- Fluorescent Lectin Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 23 Apr 2017to 1 Mar 2018
- 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
- Participant is willing and able to give informed consent for participation in the study.
- Male or female, aged 18 years or above
- Participants undergoing endoscopic procedures including colonoscopy and flexible sigmoidoscopy or transanal endoscopic microsurgery (TEMS), including robotic assisted TEMS
- In the investigator's opinion, is able and willing to comply with all study requirements
Who cannot join
- Participant who is unable to unwilling to give informed consent
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. If there is an uncertainty regarding whether a woman could be pregnant, then they will be excluded from the study
- Participants with known egg allergies, ovalbumin allergy and soya allergies
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Thomas Barnes
Oxford, Oxfordshire, OX3 7LE
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 9DS
About this study
This is a feasibility study investigating the use of a fluorescently conjugated lectin to identify colorectal dysplasia and cancer during colonoscopy and surgery.
- Conditions
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Polyp
- Being tested
- Fluorescent Lectin Application
- Keywords
- Colonoscopy, Fluorescence guided surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescent Lectin ApplicationDrug
Fluorescein conjugated wisteria floribunda (a lectin).
| Study group | Role | What they receive |
|---|---|---|
| Fluorescent Lectin Application | Experimental | Fluorescein conjugated wisteria floribunda will be sprayed onto the colonic surface during colonoscopy or TEM surgery. Receives: Drug: Fluorescent Lectin Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal to background ratios of identified colonic lesions under white light and under fluorescence
This outcome measure compares the fluorescence signal of lesions identified during colonoscopy.
Measured: During procedure
Number of dysplastic and cancerous lesions identified under white light and under fluorescence
Number of lesions identified under white light colonoscopy will be compared to the number of lesions identified under fluorescence.
Measured: During procedure
Secondary outcomes (2)
Number of dysplastic and cancerous lesions identified under white light and fluorescence in different subgroups
Assessment of subgroups including ulcerative colitis, lesions suspicious of sessile serrated adenomas / traditional serrated adenomas
Measured: 12 months
Resection margin of of lesions undergoing TEMS resection under white light and under fluorescence.
Planned resection margins will be compared under white light and under fluorescence. R0/R1 resection rates will be assessed post operatively.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start23 Apr 2017
- Primary completion1 Mar 2018 (estimated)
- Study completion1 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TREVOR MING-YEE YEUNG, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070613
- Sponsor's protocol ID
- R37106
- Status last verified
- Jul 2017
- First submitted
- 22 Feb 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be confirmed
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Use of Fluorescent Lectins to Identify Dysplasia and Cancer During Endoscopy and Surgery
- ClinicalTrials.gov ID
- NCT03070613
- Acronym / sponsor ID
- R37106
- Conditions
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Polyp
- Keywords
- Colonoscopy, Fluorescence guided surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 23 Apr 2017 (actual)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 Mar 2018 (estimated)
- First posted
- 3 Mar 2017 (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.
This is a feasibility study investigating the use of a fluorescently conjugated lectin to identify colorectal dysplasia and cancer during colonoscopy and surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorescent Lectin Application | Experimental | Drug: Fluorescent Lectin ApplicationFluorescein conjugated wisteria floribunda will be sprayed onto the colonic surface during colonoscopy or TEM surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or female, aged 18 years or above
- Participants undergoing endoscopic procedures including colonoscopy and flexible sigmoidoscopy or transanal endoscopic microsurgery (TEMS), including robotic assisted TEMS
- In the investigator's opinion, is able and willing to comply with all study requirements
Key exclusion criteria (3 listed)
- Participant who is unable to unwilling to give informed consent
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. If there is an uncertainty regarding whether a woman could be pregnant, then they will be excluded from the study
- Participants with known egg allergies, ovalbumin allergy and soya allergies
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 |
|---|---|---|
| Fluorescent Lectin ApplicationFluorescein conjugated wisteria floribunda (a lectin). | Drug | Fluorescent Lectin Application |
Primary outcome
Signal to background ratios of identified colonic lesions under white light and under fluorescence
Time frame: During procedure
This outcome measure compares the fluorescence signal of lesions identified during colonoscopy.
Number of dysplastic and cancerous lesions identified under white light and under fluorescence
Time frame: During procedure
Number of lesions identified under white light colonoscopy will be compared to the number of lesions identified under fluorescence.
2 secondary outcomes
Number of dysplastic and cancerous lesions identified under white light and fluorescence in different subgroups
Time frame: 12 months
Resection margin of of lesions undergoing TEMS resection under white light and under fluorescence.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Individual participant dataSharing planned: Undecided. To be confirmed
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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.
2 sites 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 Fluorescent Lectin Application in people with Colorectal Cancer and Colorectal Neoplasms, run by University of Oxford at 2 sites in United Kingdom.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Results are not available in the source record.
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?
Signal to background ratios of identified colonic lesions under white light and under fluorescence (time frame: During procedure). 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?
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 18 Jul 2017.