Colorectal Cancer Clinical Trial
— KCC 1BOfficial title:
Phase 1B Study of KCC Peptide Application in the Colon
Verified date | April 2017 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | August 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - 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 - 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. Exclusion Criteria: - Subjects with known allergy or negative reaction to fluorescein or derivatives. - Subjects on active chemotherapy or radiation treatment - Pregnant or trying to conceive |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
Danielle Kim Turgeon | Olympus Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | One time during colonoscopy |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Completed |
NCT00098787 -
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05425940 -
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
|
Phase 3 | |
Suspended |
NCT04595604 -
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
|
N/A | |
Completed |
NCT03414125 -
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
|
N/A | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT03874026 -
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
N/A | |
Completed |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Recruiting |
NCT05568420 -
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
|
||
Recruiting |
NCT02972541 -
Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
|
N/A | |
Completed |
NCT02876224 -
Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors
|
Phase 1 | |
Completed |
NCT01943500 -
Collection of Blood Specimens for Circulating Tumor Cell Analysis
|
N/A |