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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
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,476,407 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,881,073 Total Patients Enrolled
Maria E MartinezPrincipal InvestigatorUniversity of California, San Diego
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study open to adults over the age of 35?
"This particular clinical trial requires that participants are aged 50-75."
Answered by AI
How can I sign up for the clinical trial?
"Colorectal carcinoma patients that are between 50-75 years old may be qualified for this clinical trial. Up to 45000 individuals can participate in the study."
Answered by AI
Are investigators still looking for patients to participate in this trial?
"The study in question, which was first posted on 6/8/2021 and last updated on 6/17/202, is not actively recruiting patients. There are 1,108 other clinical trials that are currently searching for candidates."
Answered by AI
What are the possible side effects of this medication?
"This is a Phase 3 trial, so there is some data supporting efficacy and multiple rounds of data supporting safety. Therefore, the Power team rates this treatment as having a level 3 safety risk."
Answered by AI
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