Profiling blood biomarkers in colorectal cancer patients
Tempus CRC Surveillance Study: A Longitudinal Circulating Tumor DNA (ctDNA) Biomarker Profiling Study of Patients With Colorectal Cancer (CRC) Using Comprehensive Next-Generation Sequencing (NGS)Assays
This study is testing how blood samples from colorectal cancer patients can help doctors understand how the disease is progressing and how well treatments are working.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tempus AI Industry-sponsored |
| Locations | 20 sites (Fort Smith, Arkansas and 19 other locations) |
| Trial ID | NCT05234177 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates patients with colorectal cancer (CRC) by conducting longitudinal plasma ctDNA biomarker profiling alongside their standard treatment and disease monitoring. Participants will provide blood samples during routine surveillance visits to assess the presence of circulating tumor DNA (ctDNA). The study aims to enhance understanding of CRC progression and treatment response through genomic profiling. It involves multiple centers to gather diverse data on patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with known or suspected colorectal adenocarcinoma who are undergoing or have undergone surgical resection with curative intent.
Not a fit: Patients who are not willing to provide additional blood samples or have a pathology inconsistent with colorectal adenocarcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and personalized treatment strategies for colorectal cancer patients.
How similar studies have performed: Other studies utilizing ctDNA profiling in cancer monitoring have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Not willing to have additional blood samples collected * Pathology that is not consistent with colorectal adenocarcinoma
Where this trial is running
Fort Smith, Arkansas and 19 other locations
- Mercy Clinic Oncology - Fort Smith — Fort Smith, Arkansas, United States (Recruiting)
- MemorialCare — Fountain Valley, California, United States (Recruiting)
- The Center for Cancer and Blood Disorders — Bethesda, Maryland, United States (Recruiting)
- Mercy Clinic Oncology and Hematology - Joplin — Joplin, Missouri, United States (Recruiting)
- Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center — Springfield, Missouri, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
- Mercy Clinic Oncology and Hematology - Sindelar Cancer Center — St Louis, Missouri, United States (Recruiting)
- Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center — St Louis, Missouri, United States (Recruiting)
- Nebraska Cancer Specialists — Omaha, Nebraska, United States (Recruiting)
- Southeastern Medical Oncology Center — Goldsboro, North Carolina, United States (Recruiting)
- Aultman Hospital — Canton, Ohio, United States (Recruiting)
- TriHealth Cancer Institute — Cincinnati, Ohio, United States (Recruiting)
- Ohio State University — Columbus, Ohio, United States (Recruiting)
- OhioHealth Research Institute — Columbus, Ohio, United States (Recruiting)
- Toledo Clinic Cancer Center — Toledo, Ohio, United States (Recruiting)
- Mercy Clinic Oncology and Hematology - Coletta — Oklahoma City, Oklahoma, United States (Recruiting)
- Cancer Care Associates of York — York, Pennsylvania, United States (Recruiting)
- Utah Cancer Specialists — Salt Lake City, Utah, United States (Recruiting)
- University of Washington / Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
- ThedaCare Regional Cancer Center — Appleton, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Kristiyana Kaneva, MD, MS — Tempus AI, Inc.
- Study coordinator: CRC Surveillance Study
- Email: gemini-crc@tempus.com
- Phone: (833) 514-4187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.