Tempus CRC Surveillance Study: A ctDNA Biomarker Profiling Study of Patients With CRC Using NGS Assays

NCT05234177 | Recruiting

• 1 other identifier: TP-CA-004
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 20

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.

Conditions

Colorectal Cancer

Keywords

Cancer; Oncology; Observational; Genomic Profiling; Precision medicine; CRC; Colorectal Cancer; NGS; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Recurrence-Free Survival

  Recurrence-Free Survival as assessed by standard radiographic imaging, measured from the day of completion of definitive treatment to first radiographic recurrence or death

  2 years

Secondary Outcomes (3)

• Sensitivity

  2 years

• Specificity

  2 years

• Positive Predictive Value

  2 years

Other Outcomes (2)

• Overall Survival

  2 years or until the patient is reported deceased

• Lead Time

  2 years

Study Arms (1)

Participants with stage I-IV colorectal cancer (CRC)

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

Other: Observation

Interventions

Observation OTHER

No intervention

Participants with stage I-IV colorectal cancer (CRC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This protocol targets patients with colorectal cancer (CRC), stage I-IVA disease

You may qualify if:

• 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.
• years old or older
• Willing and able to provide informed consent
• Willing to have additional blood samples collected during routine surveillance visits

You may not qualify if:

• Not willing to have additional blood samples collected
• Pathology that is not consistent with colorectal adenocarcinoma

Sponsors & Collaborators

• Tempus AI: lead

Study Sites (20)

Mercy Clinic Oncology - Fort Smith

Fort Smith, Arkansas, 72903, United States

RECRUITING

MemorialCare

Fountain Valley, California, 92708, United States

RECRUITING

The Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

RECRUITING

Mercy Clinic Oncology and Hematology - Joplin

Joplin, Missouri, 64804, United States

RECRUITING

Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center

Springfield, Missouri, 65804, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Mercy Clinic Oncology and Hematology - Sindelar Cancer Center

St Louis, Missouri, 63128, United States

RECRUITING

Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center

St Louis, Missouri, 63141, United States

RECRUITING

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

RECRUITING

Southeastern Medical Oncology Center

Goldsboro, North Carolina, 27543, United States

RECRUITING

Aultman Hospital

Canton, Ohio, 44710, United States

RECRUITING

TriHealth Cancer Institute

Cincinnati, Ohio, 45220, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

RECRUITING

Toledo Clinic Cancer Center

Toledo, Ohio, 43623, United States

RECRUITING

Mercy Clinic Oncology and Hematology - Coletta

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

Cancer Care Associates of York

York, Pennsylvania, 17403, United States

RECRUITING

Utah Cancer Specialists

Salt Lake City, Utah, 84124, United States

RECRUITING

University of Washington / Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue samples will be collected

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Kristiyana Kaneva, MD, MS

  Tempus AI, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CRC Surveillance Study

CONTACT

(833) 514-4187; gemini-crc@tempus.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 10, 2022
• Study Start: June 21, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

US (20)