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Cancer Screening

Blood-Based Screening for Colon Cancer

N/A

Recruiting

Led By Karen J. Elmore, MD

Research Sponsored by Ballad Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial helps understand implementation and acceptability of a non-invasive CRC screening test in primary care settings, and its impact on patient adherence.

Who is the study for?

This trial is for individuals aged 45-84 who are at average risk for colorectal cancer, as per USPSTF guidelines. They must understand the study and be willing to participate, including providing blood samples if they choose the blood-based test. People with a personal or high-risk family history of CRC, inflammatory bowel disease, symptoms like blood in stool, or those due for colonoscopy surveillance cannot join.Check my eligibility

What is being tested?

The study is testing how well a noninvasive blood-based screening method works in primary care settings for detecting colorectal cancer. It aims to assess patient acceptance and adherence to this new form of CRC screening compared to traditional methods.See study design

What are the potential side effects?

Since this trial involves a noninvasive blood test rather than medication or invasive procedures, side effects are minimal but may include discomfort or bruising from the needle used to draw blood.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Opted to be screened by either SOC or study diagnostic test

Secondary outcome measures

Opted to be screened by the study diagnostic test instead of SOC

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ExperimentalExperimental Treatment1 Intervention

Patients judged to be at average risk of CRC will be engaged in a conversation about CRC risk factors and standard of care (SOC) screening options as well as the option to be screened with a blood-based test which is not currently standard of care. Patients who express a desire to be screened using the SOC options or the blood-based non-SOC option will be considered part of the experimental group.

Group II: ControlActive Control1 Intervention

Patients judged to be at average risk of CRC will be engaged in a conversation about CRC risk factors and standard of care (SOC) screening options. Patients who express a desire to be screened using the SOC options will be considered part of the control group.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ballad HealthLead Sponsor

1 Previous Clinical Trials

100 Total Patients Enrolled

Karen J. Elmore, MDPrincipal InvestigatorBallad Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical study accepting new participants at the moment?

"According to records on clinicaltrials.gov, this trial is actively seeking participants; the initial posting was made on October 12th 2023 and the most recent update occurred November 1st of that same year."

Answered by AI

How many subjects are being evaluated in this research endeavor?

"Affirmative. Per the information made available on clinicaltrials.gov, this study is currently enrolling participants. Originally posted on October 12th 2023 and recently edited November 1st 2023, 600 patients need to be recruited from one single medical site."

Answered by AI

Are minors eligible to join this experiment?

"This clinical trial is designed for those between 45 and 84 years of age. For younger patients, there are 34 other trials that could be considered; similarly 1061 studies might be suitable options for older applicants."

Answered by AI