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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05234177
• Other study ID #: TP-CA-004
• Status: Recruiting
• Start date: June 21, 2022
• Est. completion date: February 2027

Study information

• Verified date: May 2024
• Source: Tempus AI
• Contact: CRC Surveillance Study
• Phone: (833) 514-4187
• Email: gemini-crc[@]tempus.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: February 2027
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.
• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Observation
No intervention

Locations

Country	Name	City	State
United States	ThedaCare Regional Cancer Center	Appleton	Wisconsin
United States	The Center for Cancer and Blood Disorders	Bethesda	Maryland
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	Mercy Clinic Oncology - Fort Smith	Fort Smith	Arkansas
United States	MemorialCare	Fountain Valley	California
United States	Southeastern Medical Oncology Center	Goldsboro	North Carolina
United States	Mercy Clinic Oncology and Hematology - Joplin	Joplin	Missouri
United States	Mercy Clinic Oncology and Hematology - Coletta	Oklahoma City	Oklahoma
United States	Nebraska Cancer Specialists	Omaha	Nebraska
United States	Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center	Saint Louis	Missouri
United States	Mercy Clinic Oncology and Hematology - Sindelar Cancer Center	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	University of Washington / Fred Hutchinson Cancer Center	Seattle	Washington
United States	Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center	Springfield	Missouri
United States	Toledo Clinic Cancer Center	Toledo	Ohio
United States	Cancer Care Associates of York	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Tempus AI

Country where clinical trial is conducted

United States, 

References & Publications (39)

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Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Survival	The duration of time between enrollment and death for any reason	2 years or until the patient is reported deceased
Other	Lead Time	Lead time defined as the interval between ctDNA detection and clinical detection of recurrence.	2 years
Primary	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	Sensitivity	Sensitivity defined as the proportion of participants who develop recurrence who have ctDNA detected.	2 years
Secondary	Specificity	Specificity defined as the proportion of participants who do not develop recurrence who do not have ctDNA detected.	2 years
Secondary	Positive Predictive Value	Positive predictive value (PPV) defined as the proportion of participants who have ctDNA detected who recur.	2 years