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

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ClinicalTrials.gov Identifier: NCT05234177
Recruitment Status : Recruiting
First Posted : February 10, 2022
Last Update Posted : April 3, 2024
Sponsor:
Information provided by (Responsible Party):
Tempus AI

Study Description
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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.

Condition or disease Intervention/treatment
Colorectal Cancer Other: Observation

Study Design
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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : June 21, 2022
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2027
Groups and Cohorts
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Group/Cohort Intervention/treatment
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
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence-Free Survival [ Time Frame: 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 :
  1. Sensitivity [ Time Frame: 2 years ]
    Sensitivity defined as the proportion of participants who develop recurrence who have ctDNA detected.

  2. Specificity [ Time Frame: 2 years ]
    Specificity defined as the proportion of participants who do not develop recurrence who do not have ctDNA detected.

  3. Positive Predictive Value [ Time Frame: 2 years ]
    Positive predictive value (PPV) defined as the proportion of participants who have ctDNA detected who recur.


Other Outcome Measures:
  1. Overall Survival [ Time Frame: 2 years or until the patient is reported deceased ]
    The duration of time between enrollment and death for any reason

  2. Lead Time [ Time Frame: 2 years ]
    Lead time defined as the interval between ctDNA detection and clinical detection of recurrence.


Biospecimen Retention:   Samples With DNA
Blood and tissue samples will be collected

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This protocol targets patients with colorectal cancer (CRC), stage I-IV disease
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05234177


Contacts
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Contact: CRC Surveillance Study (833) 514-4187 gemini-crc@tempus.com

Locations
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Sponsors and Collaborators
Tempus AI
Investigators
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Principal Investigator: Kristiyana Kaneva, MD, MS Tempus AI, Inc.
More Information
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Publications:
Institute NC, National Cancer Institute. AJCC Cancer Staging Manual 8th Edition. Definitions. 2020

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Responsible Party: Tempus AI
ClinicalTrials.gov Identifier: NCT05234177    
Other Study ID Numbers: TP-CA-004
First Posted: February 10, 2022    Key Record Dates
Last Update Posted: April 3, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tempus AI:
Cancer
Oncology
Observational
Genomic Profiling
Precision medicine
 CRC
Colorectal Cancer
NGS
Biomarkers
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases