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Mailed FIT for Colorectal Cancer (SCORE Trial)

N/A
Waitlist Available
Led By Daniel S Reuland, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 45-75 years
No record of comorbidities or screening contraindications, including dementia, hospice care, assisted living, end-stage renal disease, and other cancers (glioblastoma, pancreatic cancer, lung cancer, esophageal cancer, liver and bile duct cancer, mesothelioma)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days after randomization
Awards & highlights

SCORE Trial Summary

This trial will test whether mailing fecal immunochemical tests (FITs) to adults ages 45-75 will increase colorectal cancer (CRC) screening rates. The study will be implemented in two age groups: 45-49 years and 50-75 years.

Who is the study for?
The SCORE trial is for U.S. adults aged 45-75 who are at average risk for colorectal cancer (CRC) and haven't had certain CRC screenings or a diagnosis of CRC or other serious cancers. Participants must have visited their clinic in the last 18 months and live in North Carolina.Check my eligibility
What is being tested?
This study tests if mailing fecal immunochemical tests (FITs) to people can increase CRC screening rates. There are two age groups: one from 45-49, receiving either an enhanced envelope or plain envelope FIT; another group from 50-75 receives a standard mailed FIT intervention.See study design
What are the potential side effects?
Since this trial involves non-invasive screening with mailed FIT kits rather than medication, there are no direct side effects like those associated with drugs. However, participants may experience anxiety or discomfort related to the testing process.

SCORE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 45 and 75 years old.
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I do not have dementia, am not in hospice care, do not live in assisted living, and do not have end-stage renal disease or other specified cancers.
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I have never been diagnosed with colorectal cancer or had my entire colon removed.

SCORE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days after abnormal fit result date
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days after abnormal fit result date for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects, ages 50-75, who complete CRC screening within 6 months (Trial - Age Group 50-75)
Secondary outcome measures
Incremental cost of each additional patient screened in the intervention arm compared to usual care (Trial - Age Group 50-75)
Number of CRCs and advanced adenomas detected at 12 months (Trial - Age Group 50-75)
Number of days from CRC diagnosis to the date of evaluation for CRC treatment (Trial - Age Group 50-75)
+7 more
Other outcome measures
Number of days from abnormal FIT result date to diagnostic colonoscopy (Trial - Age Group 50-75)
Proportion of participants who return a completed mailed FIT at 90 days (exploratory outcome) (Trial Age Group 50-75)

SCORE Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Trial Mailed FIT Intervention - Age Group 50-75Experimental Treatment1 Intervention
Subjects randomized to this arm are 50-75 years of age and eligible for CRC screening using FIT per electronic health record at either of two FQHCs. Only subjects who are 50-75 years of age are randomized to this arm. Subjects who are 50-75 cannot be randomized to Arm 3 or Arm 4.
Group II: Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49Experimental Treatment1 Intervention
Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one FQHC. Only subjects who are 45-49 years of age are randomized to this arm. Subjects who are 45-49 years of age cannot be randomized to Arm 1 or Arm 2 of the main trial.
Group III: Trial Usual Care - Age Group 50-75Active Control1 Intervention
Subjects randomized to this arm are 50-75 years of age and eligible for CRC screening using FIT per electronic health record at either of two FQHCs. Only subjects who are 50-75 years of age are randomized to this arm. Subjects who are 50-75 cannot be randomized to Arm 3 or Arm 4.
Group IV: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-40Active Control1 Intervention
Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one FQHC. Only subjects who are 45-49 years of age are randomized to this arm. Subjects who are 45-49 years of age cannot be randomized to Arm 1 or Arm 2 of the main trial.

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
83,932 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,927,923 Total Patients Enrolled
East Carolina UniversityOTHER
107 Previous Clinical Trials
34,409 Total Patients Enrolled

Media Library

Mailed FIT Outreach Clinical Trial Eligibility Overview. Trial Name: NCT04406714 — N/A
Colorectal Cancer Research Study Groups: Trial Usual Care - Age Group 50-75, Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49, Trial Mailed FIT Intervention - Age Group 50-75, Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-40
Colorectal Cancer Clinical Trial 2023: Mailed FIT Outreach Highlights & Side Effects. Trial Name: NCT04406714 — N/A
Mailed FIT Outreach 2023 Treatment Timeline for Medical Study. Trial Name: NCT04406714 — N/A

Frequently Asked Questions

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

Who can be part of this research endeavor?

"This research endeavour seeks to enrol 4,400 individuals between 45 and 75 years of age who have colorectal cancer. Furthermore, these participants must meet additional criteria including: having an average risk for CRC (defined as lacking any history or record of colonic adenomas/polyps), not having undergone FOBT/FIT nor a CT Colonography within the past 12 months and 10 years respectively; no records indicating comorbidities such as dementia, end-stage renal disease etc.; being actively registered at the clinic that is conducting this trial; providing a valid North carolina mailing address in their medical records; and lastly"

Answered by AI

What purpose does this experiment seek to accomplish?

"This clinical trial has two primary goals that will be monitored over a period of six months. The first is to ascertain the proportion of participants aged 50-75 who complete colorectal cancer screening within this timeframe, and the second is to measure the incremental cost associated with each additional patient screened in comparison to usual care. Secondary objectives include ascertaining what percentage of those with abnormal FIT/FOBT results receive follow up colonoscopies, as well as quantifying how many people are referred for cancer treatment post diagnosis through electronic health records review."

Answered by AI

Is there availability to join this research project at present?

"The data posted on clinicaltrials.gov suggests that this trial is no longer seeking participants, as the last update was made over a year ago. Nevertheless, there are still 1,064 other trials open to prospective candidates at present."

Answered by AI

Does this clinical trial accommodate individuals aged 40 and above?

"The accepted age range for this medical trial is between 45 and 75 years old. There are a total of 38 trials available to those under 18, while 1050 studies can be found that focus on patients aged 65 or older."

Answered by AI
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~926 spots leftby Apr 2025