Colon Cancer PreventionPhase 1NCT03148119
Study of QRH-882260 Heptapeptide Application in the Colon
A Phase 1 study testing QRH-882260 Heptapeptide and Scanning Fiber Endoscope in people with Colon Cancer Prevention, run by Danielle Kim Turgeon at 1 site in United States.
Trial summary
A Phase 1B study of the efficacy of a topically-administered 7-amino acid peptide labeled with a near-infrared fluorophore Cy5 for detecting neoplastic areas of the colon is proposed. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colon Cancer Prevention
- What is being tested?
- QRH-882260 Heptapeptide and Scanning Fiber Endoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2017to 11 Jul 2017
- 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
- Subject meets at least one of the following criteria:
- At increased risk for colorectal cancer (CRC) and colonic polyps
- Known colonic adenomas scheduled for colonic resection
- Scheduled for outpatient colonoscopy for follow up surveillance of IBD with known dysplasia or who are at high risk for high grade dysplasia
- Subject is scheduled for outpatient colonoscopy in the Medical Procedures Unit at UMHS
- Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) Standard practice guidelines for safely proceeding with the procedure will be sufficient for the study
- Age 18 to 100 years
- Willing and able to sign informed consent
Who cannot join
- Subjects with known allergy or negative reaction to Cy5 (a near-infrared fluorophore) 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 IB Study of QRH-882260 Heptapeptide Application in the Colon
A Phase 1B study of the efficacy of a topically-administered 7-amino acid peptide labeled with a near-infrared fluorophore Cy5 for detecting neoplastic areas of the colon is proposed. The study will test the efficacy of administering this agent (QRH-882260 Heptapeptide) to human subjects undergoing clinically-indicated colonoscopy for endoscopic resection of known colonic adenomas or for surveillance biopsies of known dysplasia in the setting of irritable bowel disease (IBD). Up to 120 evaluable subjects will be enrolled.
Subjects will be recruited around scheduled standard of care procedures. The endoscopists performing the procedures are all endoscopists credentialed at the University of Michigan to do these procedures. Urine for dipstick pregnancy testing (if applicable) will be collected before the procedure, along with medical information. Vital signs are routinely monitored throughout the clinical procedure and are available in the electronic medical record. The endoscopy will proceed per the University of Michigan Health System (UMHS) standard of care. The endoscopist performing the clinical procedure will evaluate the potential risk (if any) for the subject to continue with the procedure or study. Five mL of the reconstituted QRH-882260 Heptapeptide (~100 μM) will be sprayed onto the site of interest through a catheter in the endoscope. Five minutes after QRH-882260 Heptapeptide application, the unbound peptide will be washed off using the endogator irrigator and the residual liquid will be suctioned. Pictures with white-light and fluorescence will be taken with the scanning fiber based molecular imaging endoscopic probe inserted via the instrument channel of the standard endoscope before the QRH-882260 Heptapeptide application, immediately after application and then again after the QRH-882260 Heptapeptide will be washed off. The area of interest identified will be resected/biopsied per discretion of the endoscopist per clinical care. All specimens taken are for clinical care only (not research use) and will be sent for routine histology per UMHS standard of care.
- Conditions
- Colon Cancer Prevention
- Being tested
- QRH-882260 Heptapeptide, Scanning Fiber Endoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QRH-882260 HeptapeptideDrug
Also called QRH
topical spray; fluorescently-labeled peptide composed of a 7-amino acid sequence [Gln-Arg-His-Lys-Pro-Arg-Glu] attached via a 5 amino acid linker [Gly-Gly-Gly-Ser-Lys] to a near-infrared fluorophore, Cy5. The complete peptide sequence is written as: Gln-Arg-His-Lys-Pro-Arg-Glu-Gly-Gly-Gly-Ser-Lys(Cy5)-NH2, and is abbreviated as: QRHKPRE-GGGSK-(Cy5)-NH2.
Scanning Fiber EndoscopeDevice
Endoscope used for providing the light via laser to image the area of interest in the colon after the QRH has been sprayed and rinsed.
| Study group | Role | What they receive |
|---|---|---|
| Topical QRH Heptapeptide Administration | Experimental | Not described Receives: Drug: QRH-882260 Heptapeptide; Device: Scanning Fiber Endoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of QRH-882260 Heptapeptide administration-related adverse events
Continued monitoring of safety in subjects as measured by the number of Adverse Event (AE) assessments, severity (grade), and relationship to the study drug (any that could be related).
Measured: 1 year
Secondary outcomes (1)
Efficacy of QRH-882260 Heptapeptide administration for detection of polypoid and non-polypoid colonic neoplasia
The test product efficacy will be assessed by evaluating the fluorescence intensified measured from suspicious regions of colonic mucosa where the fluorescently-labeled peptide (QRH-882260) is administered. Measurement of peptide binding will be evaluated by the fluorescence intensity measured from the suspicious (target) region and normal tissues (background) to produce a target-to-background ratio.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start31 Mar 2017
- Primary completion11 Jul 2017
- Study completion11 Jul 2017
Why it stopped: It was decided to use the QRH for a new study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer PreventionStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danielle Kim Turgeon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Danielle Kim Turgeon, University of Michigan
- Investigators
- D K Turgeon, MD, Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148119
- Sponsor's protocol ID
- HUM00122077
- Status last verified
- Apr 2018
- First submitted
- 12 Apr 2017
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IB Study of QRH-882260 Heptapeptide Application in the Colon
- ClinicalTrials.gov ID
- NCT03148119
- Acronym / sponsor ID
- HUM00122077
- Conditions
- Colon Cancer Prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was decided to use the QRH for a new study.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Danielle Kim TurgeonUniversity, hospital or other
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 11 Jul 2017 (actual)
- Study completion
- 11 Jul 2017 (actual)
- First posted
- 10 May 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.
A Phase 1B study of the efficacy of a topically-administered 7-amino acid peptide labeled with a near-infrared fluorophore Cy5 for detecting neoplastic areas of the colon is proposed. The study will test the efficacy of administering this agent (QRH-882260 Heptapeptide) to human subjects undergoing clinically-indicated colonoscopy for endoscopic resection of known colonic adenomas or for surveillance biopsies of known dysplasia in the setting of irritable bowel disease (IBD). Up to 120 evaluable subjects will be enrolled.
Subjects will be recruited around scheduled standard of care procedures. The endoscopists performing the procedures are all endoscopists credentialed at the University of Michigan to do these procedures. Urine for dipstick pregnancy testing (if applicable) will be collected before the procedure, along with medical information. Vital signs are routinely monitored throughout the clinical procedure and are available in the electronic medical record. The endoscopy will proceed per the University of Michigan Health System (UMHS) standard of care. The endoscopist performing the clinical procedure will evaluate the potential risk (if any) for the subject to continue with the procedure or study. Five mL of the reconstituted QRH-882260 Heptapeptide (~100 μM) will be sprayed onto the site of interest through a catheter in the endoscope. Five minutes after QRH-882260 Heptapeptide application, the unbound peptide will be washed off using the endogator irrigator and the residual liquid will be suctioned. Pictures with white-light and fluorescence will be taken with the scanning fiber based molecular imaging endoscopic probe inserted via the instrument channel of the standard endoscope before the QRH-882260 Heptapeptide application, immediately after application and then again after the QRH-882260 Heptapeptide will be washed off. The area of interest identified will be resected/biopsied per discretion of the endoscopist per clinical care. All specimens taken are for clinical care only (not research use) and will be sent for routine histology per UMHS standard of care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical QRH Heptapeptide Administration | Experimental | Drug: QRH-882260 Heptapeptide, Device: Scanning Fiber Endoscope |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At increased risk for colorectal cancer (CRC) and colonic polyps
- Known colonic adenomas scheduled for colonic resection
- Scheduled for outpatient colonoscopy for follow up surveillance of IBD with known dysplasia or who are at high risk for high grade dysplasia
- Subject is scheduled for outpatient colonoscopy in the Medical Procedures Unit at UMHS
- Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) Standard practice guidelines for safely proceeding with the procedure will be sufficient for the study
Key exclusion criteria (3 listed)
- Subjects with known allergy or negative reaction to Cy5 (a near-infrared fluorophore) 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 |
|---|---|---|
| QRH-882260 HeptapeptideAlso: QRHtopical spray; fluorescently-labeled peptide composed of a 7-amino acid sequence [Gln-Arg-His-Lys-Pro-Arg-Glu] attached via a 5 amino acid linker [Gly-Gly-Gly-Ser-Lys] to a near-infrared fluorophore, Cy5. The complete peptide sequence is written as: Gln-Arg-His-Lys-Pro-Arg-Glu-Gly-Gly-Gly-Ser-Lys(Cy5)-NH2, and is abbreviated as: QRHKPRE-GGGSK-(Cy5)-NH2. | Drug | Topical QRH Heptapeptide Administration |
| Scanning Fiber EndoscopeEndoscope used for providing the light via laser to image the area of interest in the colon after the QRH has been sprayed and rinsed. | Device | Topical QRH Heptapeptide Administration |
Primary outcome
Incidence of QRH-882260 Heptapeptide administration-related adverse events
Time frame: 1 year
Continued monitoring of safety in subjects as measured by the number of Adverse Event (AE) assessments, severity (grade), and relationship to the study drug (any that could be related).
1 secondary outcome
Efficacy of QRH-882260 Heptapeptide administration for detection of polypoid and non-polypoid colonic neoplasia
Time frame: 1 year
Results and safety
The study was stopped early (reason given: It was decided to use the QRH for a new study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- 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.
D K Turgeon, MD study director
University of Michigan
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 QRH-882260 Heptapeptide and Scanning Fiber Endoscope in people with Colon Cancer Prevention, 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 8 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: stopped early, as of the sponsor's last update on 24 Apr 2018. 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 was stopped early (reason given: It was decided to use the QRH for a new 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?
Incidence of QRH-882260 Heptapeptide administration-related adverse events (time frame: 1 year). 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 24 Apr 2018.