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New treatment option for Colon Cancer Screening
Official title Colonoscopy Bowel Prep Comparison Among Diabetic Patients
ClinicalTrials.gov ID: NCT07351019
What this study is testing
What is Golytely?
Golytely is an investigational medicine, being studied as a potential treatment for colon cancer screening.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if the Golytely or SUPREP bowel preparation works more effectively in bowel cleansing for colorectal cancer screening with colonoscopy in patients with diabetes. The main questions this study aims to answer are: 1.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults. Healthy volunteers may be eligible.
You may be able to join if
- Participants having provided informed consent with signature on informed consent form: the informed consent process should be complete with full...
- Diabetic volunteer (defined per current ACP guidelines, and any type of DM)
- Aged 18+ years, inclusive
- Average screening risk, polyp surveillance, and family history of cancer
You likely can't join if
- Unable to provide informed consent to participate in the study Such as a mental condition rendering the participant unable to understand the nature...
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or...
- Persistent significant or severe infection, either acute or chronic
- Prior use of any investigational drug in the preceding 6 months
- Liver function impairment or persisting elevations (confirmed by retest) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or...
- Pregnant or breast-feeding women or those who plan to become pregnant during the study
See the full eligibility criteria
- Participants having provided informed consent with signature on informed consent form: the informed consent process should be complete with full discussion of all requirements and possible risks.
- Diabetic volunteer (defined per current ACP guidelines, and any type of DM)
- Aged 18+ years, inclusive
- Average screening risk, polyp surveillance, and family history of cancer
- Unable to provide informed consent to participate in the study Such as a mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the...
- Persistent significant or severe infection, either acute or chronic
- Prior use of any investigational drug in the preceding 6 months
- Liver function impairment or persisting elevations (confirmed by retest) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or direct bilirubin greater than 2x the upper limit of normal range (ULN).
- Pregnant or breast-feeding women or those who plan to become pregnant during the study
- Participants with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia (confirmed by retest):
- Hematocrit \< 35% and/or
- Absolute white blood cell count \< 3000 cells/mm3 ( L) and/or
- Platelet count \< 150 000 cells/mm3 ( L) and/or- Absolute neutrophil = 1500 cells/mm3 ( L)
- History of colorectal cancer
- Inflammatory Bowel Disease
- Past surgical history of colon resection
- Prior history of colorectal surgery
- Family history of hereditary polyposis and cancer disorders to include but not limited to FAP (Familial Adenomatous Polyposis), Gardner Syndrome, Turcot Syndrome, Lynch Syndrome, Cowden Syndrome, and Peutz-Jeghers...
- Symptomatic patients (bleeding, diarrhea, constipation, abdominal pain)
The study team makes the final eligibility decision.
Where it's taking place
- Fort Gordon, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Gordon, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.