Colon PolypsPhase 1KCC 1BNCT02156557
Study of KCC Peptide Application in the Colon
A Phase 1 study testing Colon KCC Heptapeptide in people with Colon Polyps and Colorectal Cancer, run by Danielle Kim Turgeon at 1 site in United States.
Trial summary
We are studying new ways to look for abnormal areas/tissues of the colon during a colonoscopy. The current scopes used for colonoscopies are very good. But if the area doesn't look different to the naked eye, then the scope can't improve on that. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colon Polyps, Colorectal Cancer, Inflammatory Bowel Disease (IBD)
- What is being tested?
- Colon KCC Heptapeptide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Aug 2016
- Phase
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects felt to be at increased risk for CRC and colonic polyps
- OR
- -Subjects with known colonic adenomas scheduled for colonic resection
- OR
- Subjects who are scheduled for outpatient colonoscopy for follow up surveillance of IBD with known dysplasia or who are at high risk for high grade dysplasia.
- Subjects who are scheduled for outpatient colonoscopy in the medical procedures unit at the University of Michigan Health Center
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- All subjects who are medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) who meet the inclusion/exclusion criteria will be included. Standard practice guidelines for safely proceeding with the procedure will be sufficient for our study
- Adults aged 18 to 100 years
- Willing and able to sign informed consent
- The effects of Colon KCC Heptapeptide (5-FITC-labeled peptide) on the developing human fetus are unknown. For this reason, women of childbearing potential must have a negative pregnancy test on the day of the procedure prior to receiving the Colon KCC Heptapeptide (5-FITC-labeled peptide agent) or be post-menopausal. Post-menopausal women are defined as post-hysterectomy, or over 40 and at least 18 months without menses and not on birth-control.
Who cannot join
- Subjects with known allergy or negative reaction to fluorescein or derivatives.
- Subjects on active chemotherapy or radiation treatment
- Pregnant or trying to conceive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1B Study of KCC Peptide Application in the Colon
We are studying new ways to look for abnormal areas/tissues of the colon during a colonoscopy. The current scopes used for colonoscopies are very good. But if the area doesn't look different to the naked eye, then the scope can't improve on that. We are using special stains or dyes and special scopes to see abnormal areas that are hard to see with the naked eye. The stain or dye is "fluorescent", meaning it glows when special light is used in the colonoscopy scope.
You are being asked to let us spray a peptide with a fluorescent tag onto your colon. Peptides are small chains of amino acids (the building blocks that make up proteins) linked together. The peptide we use has 7 amino acids attached to a fluorescent tag ("FIT C" or Fluoresceinisothiocyanate). FITC is used by eye doctors to examine your eyes (the yellow eye drops).
Read more
We are testing this "fluorescent peptide" to see if it will stick if there are any abnormal areas. If the peptide "sticks", it will "glow" when a special light in the scope is used. In this study, we will apply the fluorescent peptide to your colon by using a spray tube that fits in the colonoscope.
This is a phase IB study. This means that although we have applied the peptide to 25 people in our first research study, we still need to learn more about "fluorescent peptide" in people. The Food and Drug Administration (FDA) has not approved this agent, but is allowing us to test it in this study. The main goal of this study is to see if the peptide "glows" well and if we can take pictures of areas that do glow.
This is a research study of the peptide and our ability to see it "glow or fluoresce". Being in this study and applying the peptide won't change how our biopsies are taken or how your colonoscopy is done.
- Being tested
- Colon KCC Heptapeptide
- Medical subject headings
- Colonic Polyps, Colorectal Neoplasms, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon KCC HeptapeptideBiological
- Your colonoscopy will happen as it would normally, including the medications, the colonoscope, and any clinically indicated biopsies or polypectomies.
- The fluorescent peptide will be sprayed on to the walls of your colon around the areas that might have a polyp, areas of IBD, or another area of interest. Your doctor will select one area to apply the peptide in your colon. The peptide comes in a single-use sealed vial from the investigational pharmacy. Sterile saline (salt-water) is added to the vial. The powder is mixed well and pulled into a syringe. The peptide is then "injected" into a special, single-use "sprayer", like a garden hose, that fits down the endoscope channel. The peptide will be sprayed in your colon. This is part of the study.
- The endoscopist will take pictures of the area before and after the peptide spraying. They will use the camera that is part of the colonoscope.
- We will obtain copies of your endoscopy report and any pathology reports.
| Study group | Role | What they receive |
|---|---|---|
| peptide application | Experimental | Investigational Agent Administration
* KCCFPAQ-GGGSK-(5-FITC)-NH2
* 1.2 mg lyophilized powder per single-use amber vial
* Lyophilized powder reconstituted with 10 mL of 0.9% NaCl
* Final concentration of 76.4 μM for single, one-time topical application
* The entire 10 mL solution will be sprayed topically onto area of interest by the Clinical Research Associate (CRA)/physician during the procedure through a standard endoscopy spray catheter (Olympus Medical, Tokyo Japan, PW-5V-1) Receives: Biological: Colon KCC Heptapeptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of binding of peptide
The peptide will be applied during colonoscopy to areas that appear abnormal with white light endoscopy. The peptide fluorescence will be assessed via imaging to assess specificity of binding as compared to standard of care pathology interpretation of tissue.
Measured: One time during colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2016
- Study completionAug 2016
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 Colon PolypsStudies 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 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danielle Kim Turgeon
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus Corporation
- Responsible party
- Sponsor-investigator, Danielle Kim Turgeon, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156557
- Sponsor's protocol ID
- HUM00086259
- Acronym
- KCC 1B
- Status last verified
- Apr 2017
- First submitted
- 3 Jun 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Joshi BP, Dai Z, Gao Z, Lee JH, Ghimire N, Chen J, Prabhu A, Wamsteker EJ, Kwon RS, Elta GH, Stoffel EM, Pant A, Kaltenbach T, Soetikno RM, Appelman HD, Kuick R, Turgeon DK, Wang TD. Detection of Sessile Serrated Adenomas in the Proximal Colon Using Wide-Field Fluorescence Endoscopy. Gastroenterology. 2017 Apr;152(5):1002-1013.e9. doi: 10.1053/j.gastro.2016.12.009. Epub 2016 Dec 22.
PubMed 28012848
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1B Study of KCC Peptide Application in the Colon
- ClinicalTrials.gov ID
- NCT02156557
- Acronym / sponsor ID
- KCC 1B / HUM00086259
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Danielle Kim TurgeonUniversity, hospital or other
- Collaborators
- Olympus Corporation
- Study start
- Jun 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Jun 2014 (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.
We are studying new ways to look for abnormal areas/tissues of the colon during a colonoscopy. The current scopes used for colonoscopies are very good. But if the area doesn't look different to the naked eye, then the scope can't improve on that. We are using special stains or dyes and special scopes to see abnormal areas that are hard to see with the naked eye. The stain or dye is "fluorescent", meaning it glows when special light is used in the colonoscopy scope.
You are being asked to let us spray a peptide with a fluorescent tag onto your colon. Peptides are small chains of amino acids (the building blocks that make up proteins) linked together. The peptide we use has 7 amino acids attached to a fluorescent tag ("FIT C" or Fluoresceinisothiocyanate). FITC is used by eye doctors to examine your eyes (the yellow eye drops).
We are testing this "fluorescent peptide" to see if it will stick if there are any abnormal areas. If the peptide "sticks", it will "glow" when a special light in the scope is used. In this study, we will apply the fluorescent peptide to your colon by using a spray tube that fits in the colonoscope.
This is a phase IB study. This means that although we have applied the peptide to 25 people in our first research study, we still need to learn more about "fluorescent peptide" in people. The Food and Drug Administration (FDA) has not approved this agent, but is allowing us to test it in this study. The main goal of this study is to see if the peptide "glows" well and if we can take pictures of areas that do glow.
This is a research study of the peptide and our ability to see it "glow or fluoresce". Being in this study and applying the peptide won't change how our biopsies are taken or how your colonoscopy is done.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| peptide application | Experimental | Biological: Colon KCC HeptapeptideInvestigational Agent Administration * KCCFPAQ-GGGSK-(5-FITC)-NH2 * 1.2 mg lyophilized powder per single-use amber vial * Lyophilized powder reconstituted with 10 mL of 0.9% NaCl * Final concentration of 76.4 μM for single, one-time topical application * The entire 10 mL solution will be sprayed topically onto area of interest by the Clinical Research Associate (CRA)/physician during the procedure through a standard endoscopy spray catheter (Olympus Medical, Tokyo Japan, PW-5V-1) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects felt to be at increased risk for CRC and colonic polyps
- OR
- -Subjects with known colonic adenomas scheduled for colonic resection
- OR
- Subjects who are scheduled for outpatient colonoscopy for follow up surveillance of IBD with known dysplasia or who are at high risk for high grade dysplasia.
Key exclusion criteria (3 listed)
- Subjects with known allergy or negative reaction to fluorescein or derivatives.
- Subjects on active chemotherapy or radiation treatment
- Pregnant or trying to conceive
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 |
|---|---|---|
| Colon KCC Heptapeptide* Your colonoscopy will happen as it would normally, including the medications, the colonoscope, and any clinically indicated biopsies or polypectomies. * The fluorescent peptide will be sprayed on to the walls of your colon around the areas that might have a polyp, areas of IBD, or another area of interest. Your doctor will select one area to apply the peptide in your colon. The peptide comes in a single-use sealed vial from the investigational pharmacy. Sterile saline (salt-water) is added to the vial. The powder is mixed well and pulled into a syringe. The peptide is then "injected" into a special, single-use "sprayer", like a garden hose, that fits down the endoscope channel. The peptide will be sprayed in your colon. This is part of the study. * The endoscopist will take pictures of the area before and after the peptide spraying. They will use the camera that is part of the colonoscope. * We will obtain copies of your endoscopy report and any pathology reports. | Biological | peptide application |
Primary outcome
Validation of binding of peptide
Time frame: One time during colonoscopy
The peptide will be applied during colonoscopy to areas that appear abnormal with white light endoscopy. The peptide fluorescence will be assessed via imaging to assess specificity of binding as compared to standard of care pathology interpretation of tissue.
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 4 Apr 2017.
- Derived from this study: PubMed 28012848Joshi BP, Dai Z, Gao Z, Lee JH, Ghimire N, Chen J, Prabhu A, Wamsteker EJ, Kwon RS, Elta GH, Stoffel EM, Pant A, Kaltenbach T, Soetikno RM, Appelman HD, Kuick R, Turgeon DK, Wang TD. Detection of Sessile Serrated Adenomas in the Proximal Colon Using Wide-Field Fluorescence Endoscopy. Gastroenterology. 2017 Apr;152(5):1002-1013.e9. doi: 10.1053/j.gastro.2016.12.009. Epub 2016 Dec 22.
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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 Phase 1 study testing Colon KCC Heptapeptide in people with Colon Polyps and Colorectal Cancer, run by Danielle Kim Turgeon 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 10 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: finished, as of the sponsor's last update on 4 Apr 2017. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Validation of binding of peptide (time frame: One time during colonoscopy). 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 NCT02156557, 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 4 Apr 2017.