Tempus CRC Surveillance Study: A ctDNA Biomarker Profiling Study of Patients With CRC Using NGS Assays
- Conditions
- Colorectal Cancer
- Interventions
- Other: Observation
- Registration Number
- NCT05234177
- Lead Sponsor
- Tempus AI
- Brief Summary
The study is an observational multicenter evaluation of participants with colorectal cancer (CRC) who will receive longitudinal plasma ctDNA biomarker profiling in addition to their standard-of-care therapy and disease surveillance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Known or suspected colorectal adenocarcinoma (Stage I to IVA disease)
- Planning to undergo or has undergone a surgical resection for suspected adenocarcinoma of the colon or rectum with curative intent.
- 18 years old or older
- Willing and able to provide informed consent
- Willing to have additional blood samples collected during routine surveillance visits
- Not willing to have additional blood samples collected
- Pathology that is not consistent with colorectal adenocarcinoma
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with stage I-IV colorectal cancer (CRC) Observation This protocol will include participants with stage I-IV CRC who are scheduled to undergo or have undergone a surgical resection with curative intent.
- Primary Outcome Measures
Name Time Method Recurrence-Free Survival 2 years Recurrence-Free Survival as assessed by standard radiographic imaging, measured from the day of completion of definitive treatment to first radiographic recurrence or death
- Secondary Outcome Measures
Name Time Method Sensitivity 2 years Sensitivity defined as the proportion of participants who develop recurrence who have ctDNA detected.
Positive Predictive Value 2 years Positive predictive value (PPV) defined as the proportion of participants who have ctDNA detected who recur.
Specificity 2 years Specificity defined as the proportion of participants who do not develop recurrence who do not have ctDNA detected.
Trial Locations
- Locations (40)
Mercy Clinic Oncology - Fort Smith
🇺🇸Fort Smith, Arkansas, United States
MemorialCare
🇺🇸Fountain Valley, California, United States
The Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Mercy Clinic Oncology and Hematology - Joplin
🇺🇸Joplin, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Mercy Clinic Oncology and Hematology - Sindelar Cancer Center
🇺🇸Saint Louis, Missouri, United States
Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center
🇺🇸Saint Louis, Missouri, United States
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center
🇺🇸Springfield, Missouri, United States
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
Southeastern Medical Oncology Center
🇺🇸Goldsboro, North Carolina, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
TriHealth Cancer Institute
🇺🇸Cincinnati, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
OhioHealth Research Institute
🇺🇸Columbus, Ohio, United States
Toledo Clinic Cancer Center
🇺🇸Toledo, Ohio, United States
Mercy Clinic Oncology and Hematology - Coletta
🇺🇸Oklahoma City, Oklahoma, United States
Cancer Care Associates of York
🇺🇸York, Pennsylvania, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
University of Washington / Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
ThedaCare Regional Cancer Center
🇺🇸Appleton, Wisconsin, United States
Mercy Clinic Oncology - Fort Smith
🇺🇸Fort Smith, Arkansas, United States
MemorialCare
🇺🇸Fountain Valley, California, United States
The Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Mercy Clinic Oncology and Hematology - Joplin
🇺🇸Joplin, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Mercy Clinic Oncology and Hematology - Sindelar Cancer Center
🇺🇸Saint Louis, Missouri, United States
Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center
🇺🇸Saint Louis, Missouri, United States
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center
🇺🇸Springfield, Missouri, United States
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
Southeastern Medical Oncology Center
🇺🇸Goldsboro, North Carolina, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
TriHealth Cancer Institute
🇺🇸Cincinnati, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
OhioHealth Research Institute
🇺🇸Columbus, Ohio, United States
Toledo Clinic Cancer Center
🇺🇸Toledo, Ohio, United States
Mercy Clinic Oncology and Hematology - Coletta
🇺🇸Oklahoma City, Oklahoma, United States
Cancer Care Associates of York
🇺🇸York, Pennsylvania, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
University of Washington / Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
ThedaCare Regional Cancer Center
🇺🇸Appleton, Wisconsin, United States