Today, in recognition of Colorectal Cancer Awareness Month 2025, we will be looking into the latest research and clinical trials focused on colorectal cancer screening.

The following list has been carefully curated by evaluating the ongoing phase 3 & 4 trials for colorectal cancer screening, targeting adults in the United States, Spain and Mexico. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 4 years.

This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.

Now, let’s go ahead and explore the list of Colorectal Cancer Screening Clinical Trials!

Quick View Table of Colorectal Cancer Screening Clinical Trials
Study TitlePhaseEnrollmentStart DateLast Update Posted
Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer (00-046)PHASE 349525/1/2000 6/5/2024
ColoRectal Cancer Screening for Southern California Community Health CentersPHASE 3559996/8/202112/13/2024
Glucagon Use in ColonoscopiesPHASE 41004/1/2014 4/20/2021
Two Low Volume Regimens for Colorectal Cancer Screening Colonoscopy (LOWOL)PHASE 410023/11/20209/9/2022
Bowel Preparation in Colonoscopy: Lactulose Vs Polyethyleneglycol, Randomized Double-blind Comparative Clinical Trial, Multicenter StudyPHASE 43007/20/202410/30/2024

Phase 3 & 4 Clinical Trials:

Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer (00-046)

Study Details | Source

  • Sponsor: Memorial Sloan Kettering Cancer Center
  • RATIONALE: Screening tests, such as colonoscopy and fecal occult blood test, may help doctors find tumor cells early and plan better treatment for colorectal cancer.
  • PURPOSE: This randomized phase III trial is studying colonoscopy to see how well it works compared to fecal occult blood test in screening healthy participants for colorectal cancer.
  • Interventions:
    • Procedure: annual screening
    • Procedure: fecal occult blood test
    • Procedure: screening colonoscopy
    • Procedure: standard follow-up care
  • Primary Outcomes Measures:
    • Neoplastic findings as assessed by screening colonoscopy vs annual fecal occult blood test (FOBT)-directed colonoscopy
    • Burden on endoscopic and clinical resources
    • Harms associated with screening colonoscopy vs annual FOBT-directed colonoscopy
    • Benefit-to-harm ration for screening colonoscopy vs annual FOBT-directed colonoscopy
    • Level of participation in screening with FOBT-directed colonoscopy vs a single colonoscopy
      • Time frame - 5 years

ColoRectal Cancer Screening for Southern California Community Health Centers

Study Details | Source

  • Sponsor: University of California, San Diego
  • Colorectal cancer (CRC) screening can reduce cancer deaths. However, screening and abnormal test follow-up rates are low among underserved populations. The screening rates of 19-58%, and rates of colonoscopy completion after abnormal stool tests of 18-57% in community health centers (CHC) systems are low. This highlights an opportunity to improve early detection and decrease burden of CRC in our region. Mailed outreach and navigation programs have been shown to increase colonoscopy completion rate. The next step is to understand how to best implement these programs in the community on a larger scale. To achieve this goal, the investigators propose a Hub-and-Spoke intervention combining centralized strategies to maximize CRC screening, follow-up, and referral-to-care. The investigators hypothesize that this intervention will be superior to usual care for increasing CRC screening, abnormal test follow-up, and referral-to-care.
  • The investigators will conduct a randomized trial to determine effectiveness in: 1) improvement in proportion of individuals up-to-date with screening 3 years post implementation; 2) proportion with abnormal FIT who complete diagnostic colonoscopy within 6 months; and 3) proportion with CRC completing first treatment evaluation.
  • The investigators will also evaluate the implementation, scalability, and sustainability of the multi-level implementation strategy. The intervention consists of: Mailed FIT and Reminders. Eligible individuals will receive an introductory letter describing the importance of CRC screening and noting that follow-up mail will include a FIT Kit. It will also be offered to patients who completed prior mailed FIT with normal test results. All materials will be in English and Spanish. Two weeks later, participants will receive a packet via mail containing the FIT kit, a one-page invitation inviting FIT completion and FIT instructions, a postage-paid envelope for return to the patient's CHC, and COVID-19 message. For non-compliant individuals not returning the kit, a reminder phone call and text message will be delivered 2 weeks later. The investigators will track returned letters, individuals who are later found to be up-to date with screening, and those who decline screening. The CHC will provide care coordination for patients with an abnormal FIT result.
  • Interventions:
    • Other: Mailed FIT Outreach
    • Other: Standardized navigation
  • Primary Outcomes Measures:
    • Screening up-to-date (primary)
      • Proportion of age-eligible patients with clinic visit in measurement year up-to-date with screening (FIT or FOBT in prior 12 months, sigmoidoscopy in last 5 years, colonoscopy in last 10 years).
      • Time frame - Three years
    • Colonoscopy after abnormal FIT (primary)
      • Proportion of patients with abnormal FIT who complete colonoscopy within 6 months.
      • Time frame - Six months

Glucagon Use in Colonoscopies

Study Details | Source

  • Sponsor: University of California, San Francisco
  • The investigators believe that glucagon therapy will have a positive impact on key parameters of colonoscopy such as cecal intubation time, withdrawal time, total procedure time, adenoma detection rate, endoscopist's assessment of the difficulty of the procedure, patient comfort, and patient's willingness to undergo a repeat colonoscopy.
  • Interventions:
    • Drug: Glucagon
  • Primary Outcomes Measures:
    • Adenoma Detection Rate (ADR) During Colonoscopy Procedure
      • ADR was defined as the percentage of participants with at least one traditional adenoma (including tubular or villous adenomas, and adenomas with high grade dysplasia or adenocarcinoma) of any size.
      • Time frame - During colonoscopy procedure (an average of 1139 seconds for Glucagon Arm and 1353 seconds for Placebo Arm)

Two Low Volume Regimens for Colorectal Cancer Screening Colonoscopy (LOWOL)

Study Details | Source

  • Sponsor: Hospital Clinic of Barcelona
  • Colorectal cancer is the first neoplasm most commonly diagnosed in both sexes and the second leading cause of cancer death in Spain. Colorectal cancer screening Program in Barcelona was implanted in 2009 and approximately 1,500 colorectal cancer screening colonoscopies are performed annually at Hospital Clínic de Barcelona. Adequate colon preparation (anterograde cleansing with laxatives) improves polyp detection, decreases examination time, and complications. There are both low and high volume intestinal regimens with polyethylene glycol (PEG) as the main active ingredient or without it.
  • Hypothesis: Two low volumen regimens, 1L PEG plus ascorbate and magnesium citrate plus picosulphate, at starting doses have the same Adenoma Detection Rate as cleansing solutions in preparation for screening colonoscopy.
  • Interventions:
    • Drug: Plenvu
  • Primary Outcomes Measures:
    • Adenoma detection rate
      • The percentage of patients with at least one adenoma in relation to the total subjects in each group of study.
      • Time frame - 2 years.

Bowel Preparation in Colonoscopy: Lactulose Vs Polyethyleneglycol, Randomized Double-blind Comparative Clinical Trial, Multicenter Study

Study Details | Source

  • Sponsor: Hospital Civil de Guadalajara
  • The goal of this clinical trial it is to bowel the intestinal preparation with lactulose vs Polyethylene Glycol as better agent to have a quality colonoscopy and demonstrate that lactulose is most effective, has a good tolerance and the patient would have a better satisfaction, so the question is: which is the efficacy of lactulose in comparison with the Polyethylene Glycol in the intestinal preparation for the colonoscopy?
  • Interventions:
    • Combination Product: Bowel preparation before colonoscopy
    • Combination Product: Bowel preparation before colonoscopy
  • Primary Outcomes Measures:
    • Score of the bowel cleaness
      • It would be evaluated using a standardized scoring system, such as the BBPS scale.
      • Time frame - From date of randomization until the colonoscopy is done, assessed up to July 2025.
Potential Guidelines That May Be Affected Include:

  • Colorectal Cancer Screening
    • American College of Gastroenterology, American Gastroenterological Association, and American Society for Gastrointestinal Endoscopy
    • Publication: July 03, 2017

And there you have it - a roundup of Phase 3 & 4 clinical trials for colorectal cancer screening as of February 2025. Stay tuned for our next Guidelines+ Trials Rundown! In the meantime, explore more clinical trials and sign up for alerts to stay up to date with the latest published guidelines and research.

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