Biomarker Profiling for Colorectal Cancer

Recruiting at 22 trial locations

Overseen By CRC Surveillance Study

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tempus AI

Disqualifiers: Non-colorectal adenocarcinoma pathology, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to observe patients with colorectal cancer (CRC) and track changes in their blood using next-generation sequencing (NGS) assays. The goal is to monitor how blood markers, known as ctDNA, change over time as part of regular cancer care and check-ups. The trial is open to individuals with stages I to IV CRC who have undergone or plan to undergo surgery to remove the cancer. Participants must agree to provide extra blood samples during their usual doctor visits.

As an unphased trial, this study offers patients the opportunity to contribute to important research that could enhance future cancer care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for participants with colorectal cancer?

Studies have shown that Next-Generation Sequencing (NGS) is a safe and commonly used method in cancer research. NGS helps doctors understand genetic changes in cancer cells and has been used in many studies without serious safety issues.

NGS does not involve administering new drugs or treatments to patients. Instead, it analyzes blood samples to gather important information about the cancer, resulting in minimal risk from the process itself. The safety of NGS is well-established, as it is often used in routine care for cancer patients to guide treatment decisions.

In summary, NGS tests are generally well-tolerated and pose little risk to patients. They are a standard part of cancer care and research, providing valuable insights with minimal safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of NGS (Next-Generation Sequencing) assays for colorectal cancer (CRC) surveillance because this method offers a more precise and personalized approach to monitoring cancer. Unlike traditional imaging and blood tests, NGS assays analyze circulating tumor DNA (ctDNA) in the blood, potentially detecting cancer recurrence earlier and more accurately. This technique allows for tailored treatment plans based on the genetic profile of the cancer, paving the way for more effective and individualized care. By catching changes in the cancer sooner, patients might benefit from timely interventions, potentially improving outcomes.

What evidence suggests that this protocol is effective for colorectal cancer?

Research has shown that Next-Generation Sequencing (NGS) tests can aid in treating colorectal cancer. In one study, 37.5% of patients who received NGS-based treatment experienced tumor shrinkage. Another 34.4% of patients saw their cancer remain stable, with no growth. Real-world evidence also indicates that NGS helps doctors develop personalized treatment plans, often leading to better outcomes. This makes NGS a promising tool for managing colorectal cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Kristiyana Kaneva, MD, MS

Principal Investigator

Tempus AI, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Known or suspected colorectal adenocarcinoma (Stage I to IV disease)

Planning to undergo or has undergone a surgical resection for suspected adenocarcinoma of the colon or rectum with curative intent.

Willing and able to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard-of-Care Therapy

Participants receive standard-of-care therapy and undergo surgical resection with curative intent

Varies

Longitudinal ctDNA Profiling

Participants receive longitudinal plasma ctDNA biomarker profiling in addition to disease surveillance

2 years

Follow-up

Participants are monitored for recurrence and overall survival

2 years

What Are the Treatments Tested in This Trial?

Interventions

• NGS Assays

How Is the Trial Designed?

Group I: Participants with stage I-IV colorectal cancer (CRC) Experimental Treatment 1 Intervention

This protocol will include participants with stage I-IV CRC who are scheduled to undergo or have undergone a surgical resection with curative intent.

Who Is Running the Clinical Trial?

Tempus AI

Lead Sponsor

Trials

18

Recruited

20,700+

Tempus Labs

Lead Sponsor

Trials

17

Recruited

20,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11885200/

Molecular characterization of colorectal cancer (CRC) ... Overall, 22 of 30 FFPE samples completed the NGS run, representing a 73.3% success rate. A total of 552 mutations involving 29 genes were ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S109830152402357X

Assessing the Cost-Effectiveness of Next-Generation ... Our research shows that targeted panel testing, a form of NGS, reduces costs compared with conventional single-gene biomarker assays across several oncology ...

3. nature.com nature.com/articles/s41598-024-84909-9

Clinical implementation of next-generation sequencing ... Of 32 patients with measurable lesions who received NGS-based therapy, 12 (37.5%) achieved a partial response, and 11 (34.4%) achieved stable ...

4. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00206-7/fulltext

Usefulness and real-world outcomes of next generation ... According to our data, real-world outcomes after NGS testing provide evidence of the benefit of clinical judgement in patients with either ...

5. mdpi.com mdpi.com/2673-8856/5/1/4

Outcomes of Broader Genomic Profiling in Metastatic ... Our study demonstrates that standard NGS testing is both feasible and effective in real-world settings, enabling a more personalised therapeutic approach and ...

6. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1568205/full

Integrating next-generation sequencing and artificial ... In this study, we analyzed 100 unselected Colombian patients with CRC to identify pathogenic (P) and likely pathogenic (LP) germline variants.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772736X22000445

Review Molecular testing panel in colorectal cancer As a massive parallel sequencing tool, the next generation sequencing (NGS) technology has become the most cost-effective molecular platform in the clinical ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.4_suppl.172

Rapid point of care NGS in colorectal cancer. Conclusions: Here, we show that comprehensive NGS can reveal occult resistance mechanisms to standard therapy and identify actionable biomarkers ...

9. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=290

NCA - Next Generation Sequencing (NGS) for Medicare ... Use this page to view details for the decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N).