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ctDNA-Guided Therapy for Colorectal Cancer
Phase 2
Waitlist Available
Led By Carmen Allegra, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 59 mL/min/1.73m using Cockcroft-Gault equation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will compare two approaches for guiding treatment of metastatic colorectal cancer, with the goal of measuring overall survival, progression-free survival, and best overall response.
Who is the study for?
Adults with metastatic colorectal cancer who've had oxaliplatin-based therapy and are not candidates for certain definitive treatments. They must have adequate organ function, no more than one active malignancy, and agree to contraception use. Excluded are pregnant or breastfeeding women, those with MSI-H/dMMR/BRAF mutated cancers, DPD deficiency, or recent radiation/chemotherapy.Check my eligibility
What is being tested?
The trial is testing the Signatera ctDNA assay against standard scans to guide treatment choices in metastatic colorectal cancer patients. It aims to compare overall survival rates and responses between these two methods.See study design
What are the potential side effects?
Potential side effects will depend on the FDA-approved drugs used but may include typical chemotherapy-related issues like nausea, fatigue, blood cell count changes, liver enzyme alterations, and potential fertility impacts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My kidney function, measured by creatinine levels, is within the normal range.
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My liver function tests are within the required range.
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I am able to get out of my bed or chair and move around.
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My colon or rectum cancer has spread, and surgery or targeted therapy is not an option for me.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Secondary outcome measures
Best overall response
Progression free survival
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ctDNA assay-guided interventionExperimental Treatment2 Interventions
Subjects on this arm will be tested with the Signatera ctDNA assay while receiving treatment on a pre-specified sequence of FDA-approved drugs and drug combinations. Subjects will move through this sequence based on the results of the ctDNA assay. Subjects will move to a new drug or drug combination in the sequence when the ctDNA assay indicates a significant increase in ctDNA level. Subjects will also have imaging scans every 12 weeks while on each drug or drug combination and subjects will move to a new drug or drug combination if these scans indicate disease progression.
Group II: Scan-guided InterventionActive Control1 Intervention
Subjects on this arm will be treated with the same pre-specified sequence of FDA-approved drugs and drug combinations as those on the ctDNA assay- guided intervention arm. Subjects will move through the sequence based on the results of imaging scans, moving to a new drug or drug combination if imaging shows progressive disease.
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,699 Total Patients Enrolled
Natera, Inc.Industry Sponsor
47 Previous Clinical Trials
42,361 Total Patients Enrolled
Carmen Allegra, MDPrincipal InvestigatorUniversity of Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least 6 more months.I am 18 years old or older.I have a known DPD deficiency.I've had or was unable to have first-line oxaliplatin therapy for my metastatic disease and now need a different treatment.I am using or willing to use birth control during and for 12 weeks after the study.I don't have any health conditions that my doctor thinks would make the study treatment unsafe for me.I have sent my tissue and blood samples to Natera at least 10 days before starting treatment.My kidney function, measured by creatinine levels, is within the normal range.I agree to use approved birth control during and for 12 weeks after the study.I can provide a recent tissue sample from my cancer.My organs are working well.My liver function tests are within the required range.I finished my last chemotherapy or biologic therapy at least 21 days ago.I finished my radiation therapy at least 14 days before joining this study.I have been tested for Gilbert's syndrome before starting treatment.I do not have more than one active cancer.I am able to get out of my bed or chair and move around.I am using effective birth control and will continue for 12 weeks after treatment ends.My colorectal cancer is MSI-H, has dMMR, or a BRAF mutation.I am not pregnant or breastfeeding.My tumor has been tested for RAS, BRAF, and MMR/MSI.Any side effects from my previous treatments have mostly gone away.My colon or rectum cancer has spread, and surgery or targeted therapy is not an option for me.
Research Study Groups:
This trial has the following groups:- Group 1: ctDNA assay-guided intervention
- Group 2: Scan-guided Intervention
Awards:
This trial has 1 awards, including:- 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.
What are the qualifications for enrolling in this clinical research?
"This clinical trial is open to those aged 18-99 with metastatic colorectal cancer (crc). A total of 78 participants are being sought."
Answered by AI
Are there any remaining slots available in this clinical trial?
"Yes, the information from clinicaltrials.gov affirms that this research is currently recruiting participants and has been since November 4th 2021. The last modifications to the study were made on November 17th 2022, and it requires 78 individuals across 1 location for successful completion."
Answered by AI
Are senior citizens above the age of 65 permitted to participate in this clinical experiment?
"To be eligible for this trial, patients must meet the requirement of being between 18 and 99 years old. Additionally, there are 30 trials available to those under age 18 while 863 clinical studies exist for seniors 65+."
Answered by AI
Has the Signatera ctDNA assay achieved regulatory authorization?
"Although the Signatera ctDNA assay has not been thoroughly tested for efficacy yet, there is some data that suggests it is safe. Thus our team at Power gave a score of 2 to this Phase 2 trial's safety assessment."
Answered by AI
How many participants are recruited for this clinical investigation?
"Affirmative. According to the clinicaltrials.gov webpage, this trial is actively searching for participants who meet its criteria. The initial posting date was November 4th 2021 and it has since been revised on November 17th 2022. 78 individuals need to be enrolled from one medical centre in total."
Answered by AI
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