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Colorectal Cancer Screening for Colorectal Cancer
Phase 3
Waitlist Available
Led By Maria E Martinez
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
50 - 75 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three years
Awards & highlights
Study Summary
This trial will test a multi-level intervention to increase CRC screening and follow-up in underserved populations.
Who is the study for?
This trial is for individuals aged 50-75 in San Diego or Riverside Counties who are insured, have had an office visit within the last year, and are not up to date with colorectal cancer screening. They must have a valid address and phone number. Those without insurance, a valid contact method, or with past colorectal surgery/cancer are excluded.Check my eligibility
What is being tested?
The study tests whether mailing FIT kits for at-home testing and providing follow-up navigation can increase colonoscopy completion rates among those who need it. Participants will be randomly assigned to receive these interventions or usual care to compare effectiveness.See study design
What are the potential side effects?
There may not be direct side effects from participating since this trial involves mailed outreach and navigation rather than medical treatments. However, stress or discomfort related to completing the FIT test and potential subsequent procedures could occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 50 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of abnormal fit results until the date of colonoscopy completion, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of abnormal fit results until the date of colonoscopy completion, assessed up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Colonoscopy after abnormal FIT (primary)
Screening up-to-date (primary)
Secondary outcome measures
FIT Completion
Follow-up process
Time to colonoscopy after abnormal FIT
Other outcome measures
Repeat screening (exploratory outcome)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mailed FIT OutreachExperimental Treatment2 Interventions
Primer, FIT Kit, Reminders, Abnormal FIT Follow-up
Group II: Usual CareActive Control1 Intervention
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,130 Previous Clinical Trials
1,507,856 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,908,364 Total Patients Enrolled
Maria E MartinezPrincipal InvestigatorUniversity of California, San Diego
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have completed a stool test for colon cancer screening recently.I have had my entire colon removed or have been diagnosed with colorectal cancer.I am between 50 and 75 years old.I am either male or female.
Research Study Groups:
This trial has the following groups:- Group 1: Mailed FIT Outreach
- Group 2: Usual Care
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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