Screening Tools for Colorectal Cancer

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Colorectal cancer, Non-English/Spanish, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve colon cancer screening methods for people in Dallas, particularly those who are under- or uninsured. Researchers are testing various tools to personalize screening, which can help catch cancer early or even prevent it. The trial seeks participants aged 25-64 with a family history of colon cancer or conditions like inflammatory bowel disease. Participants should speak English or Spanish and must not have had colon cancer themselves.

As an unphased trial, this study offers participants the chance to contribute to important research that could enhance early detection and prevention of colon cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these screening tools are safe for colorectal cancer screening?

Research has shown that tools used to assess risk can make colon cancer screening more effective. These tools help doctors determine who should be screened and how often by analyzing a person's risk factors to create personalized screening plans.

Specific safety data for Algorithmic or Computerized Risk Stratification Tools is not available. However, as they are software-based and do not involve medical procedures or drugs, they do not cause physical side effects like medications might.

Overall, these tools are considered safe because they aim to improve the screening process without introducing new risks. They assist doctors in making better decisions about when and how to screen for colon cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to revolutionize how we screen for colorectal cancer. Unlike traditional screening methods like colonoscopies or stool tests, this trial uses advanced algorithmic and computerized risk stratification tools to assess an individual's need for screening. These tools personalize screening recommendations, potentially reducing unnecessary procedures and ensuring those at higher risk get the attention they need. By refining how we identify and prioritize screening, this trial could lead to earlier detection and better patient outcomes.

What evidence suggests that these screening tools are effective for optimizing colorectal cancer screening?

Research has shown that tools like the Algorithmic and Computerized Risk Stratification Tools, evaluated in this trial, can enhance the effectiveness of colorectal cancer screening. These tools identify individuals at higher risk for colorectal cancer, enabling more personalized screening plans. Studies have found these tools effective and practical for risk assessment, leading to improved screening outcomes. This approach allows for more accurate identification of individuals who would benefit from early screening, potentially detecting cancer at an earlier, more treatable stage. Overall, these tools can enhance the benefits of colorectal cancer screening by concentrating efforts where they are most needed. ^{1 2 3 6 7}

Who Is on the Research Team?

Celette Skinner, PhD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for men and women aged 25-64 who are visiting the clinic. Those aged 25-49 must have a family history of colorectal cancer or their own history of bowel disease or polyps. All racial and ethnic groups, as well as English and Spanish speakers, can join. People with personal colorectal cancer history, severe hearing/speech impairments, or without informed consent cannot participate.

Inclusion Criteria

No racial or ethnic group will be excluded from participation

I am between 25 and 64 years old.

I am aged 25-49 and have a family history of colon cancer or a personal history of bowel inflammation or polyps.

Exclusion Criteria

I have never had colorectal cancer.

I speak English or Spanish and can hear, speak, and have given my consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Personalized Screening Assessment

Employ innovative methods for assessing personalized guideline-based screening in the clinic setting to evaluate guideline-based, over- and under-screening

3 years

Follow-up

Participants are monitored for completion of guideline-based screening processes and follow-up of abnormal test results

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Algorithmic Risk Stratification Tool
• Computerized Risk Stratification Tool
• Step completion assessment

Trial Overview The PROSPR project aims to find the best ways to screen for colon cancer in a diverse group using safety-net clinics. It will test tools like step completion assessments and computerized risk stratification algorithms to personalize screening methods based on individual risks.

How Is the Trial Designed?

Group I: Screening Experimental Treatment 3 Interventions

Employ innovative methods for assessing personalized guideline-based screening in the clinic setting to evaluate guideline-based, over- and under-screening. Interventions include Computerized Risk Stratification Tool, Algorithmic Risk Stratification Tool, and Step completion assessment.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

A personalized outcome prediction tool for knee arthroplasty patients was developed, demonstrating good accuracy in predicting length of stay (LOS) and 90-day readmission rates, with accuracies of 71.5% and 65.0% respectively.

The tool also effectively predicted one-year improvements in patient-reported outcomes, achieving high accuracy rates of around 72% for pain, function, and quality of life scores, based on data from over 8,000 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a personalized outcome prediction tool for knee arthroplasty. Anis, HK., Strnad, GJ., Klika, AK., et al.[2020]

Patients in surgical oncology express a strong need for better educational resources, indicating a gap in perioperative information.

Both patients and providers support the use of a mobile application to enhance patient education, although providers initially see patient onboarding as a potential burden; however, they believe it could ultimately streamline workflows and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and provider perceptions on utilizing a mobile technology platform to improve surgical outcomes in the perioperative setting. Huynh, B., Barrett, J., Joachim, A., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03705897

PROSPR Project 1: Identifying and Tracking Personalized ... Interventions include Computerized Risk Stratification Tool, Algorithmic Risk Stratification Tool, and Step completion assessment.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10370261/

Colorectal Cancer Risk Assessment and Precision ... In this review, we address current CRC screening strategies and highlight the potential benefits and challenges related to precision CRC screening.

3. withpower.com withpower.com/trial/phase-colorectal-neoplasms-7-2013-f4726

Screening Tools for Colorectal Cancer · Info for Participants What data supports the effectiveness of the treatment Algorithmic Risk Stratification Tool, Computerized Risk Stratification Tool, Step completion assessment ...

4. nature.com nature.com/articles/s41698-024-00719-2

Development and validation of machine learning models ... RF algorithm-based approach is effective and feasible in YOCRC risk stratification. This could be valuable in assessing the risk of YOCRC so ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1386505623002125

Development and validation of colorectal cancer risk ... Several studies have indicated that risk-stratification can enhance the benefits of screening, but only when the risk prediction tool demonstrates adequate ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4818180/

Risk Stratification and Shared Decision-Making for ... Risk stratification optimizes the harm-benefit ratio of colonoscopy for high-risk patients, regardless of preference, and the use of alternative screening ...

7. clinicaltrial.be clinicaltrial.be/en/details/6481?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

PROSPR Project 1: Identifying and Tracking Personalized ... Project 1 addresses transitions 1 and 3, employing novel, algorithmically driven tools in clinics to determine personalized optimized screening ...