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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Sensitivity defined as the proportion of participants who develop recurrence who have ctDNA detected. | 2 years |
| Specificity | Specificity defined as the proportion of participants who do not develop recurrence who do not have ctDNA detected. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The duration of time between enrollment and death for any reason | 2 years or until the patient is reported deceased |
| Lead Time | Lead time defined as the interval between ctDNA detection and clinical detection of recurrence. |
Inclusion Criteria:
Exclusion Criteria:
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This protocol targets patients with colorectal cancer (CRC), stage I-IVA disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CRC Surveillance Study | Contact | (833) 514-4187 | gemini-crc@tempus.com |
| Name | Affiliation | Role |
|---|---|---|
| Kristiyana Kaneva, MD, MS | Tempus AI, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Clinic Oncology - Fort Smith | Recruiting | Fort Smith | Arkansas | 72903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30620402 | Background | Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34. doi: 10.3322/caac.21551. Epub 2019 Jan 8. | |
| 32133645 | Background | Siegel RL, Miller KD, Goding Sauer A, Fedewa SA, Butterly LF, Anderson JC, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2020. CA Cancer J Clin. 2020 May;70(3):145-164. doi: 10.3322/caac.21601. Epub 2020 Mar 5. |
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Blood and tissue samples will be collected
| 2 years |
| Positive Predictive Value | Positive predictive value (PPV) defined as the proportion of participants who have ctDNA detected who recur. | 2 years |
| 2 years |
| MemorialCare | Recruiting | Fountain Valley | California | 92708 | United States |
|
| The Center for Cancer and Blood Disorders | Recruiting | Bethesda | Maryland | 20817 | United States |
|
| Mercy Clinic Oncology and Hematology - Joplin | Recruiting | Joplin | Missouri | 64804 | United States |
|
| Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center | Recruiting | Springfield | Missouri | 65804 | United States |
|
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
|
| Mercy Clinic Oncology and Hematology - Sindelar Cancer Center | Recruiting | St Louis | Missouri | 63128 | United States |
|
| Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center | Recruiting | St Louis | Missouri | 63141 | United States |
|
| Nebraska Cancer Specialists | Recruiting | Omaha | Nebraska | 68130 | United States |
|
| Southeastern Medical Oncology Center | Recruiting | Goldsboro | North Carolina | 27543 | United States |
|
| Aultman Hospital | Recruiting | Canton | Ohio | 44710 | United States |
|
| TriHealth Cancer Institute | Recruiting | Cincinnati | Ohio | 45220 | United States |
|
| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
|
| OhioHealth Research Institute | Recruiting | Columbus | Ohio | 43214 | United States |
|
| Toledo Clinic Cancer Center | Recruiting | Toledo | Ohio | 43623 | United States |
|
| Mercy Clinic Oncology and Hematology - Coletta | Recruiting | Oklahoma City | Oklahoma | 73120 | United States |
|
| Cancer Care Associates of York | Recruiting | York | Pennsylvania | 17403 | United States |
|
| Utah Cancer Specialists | Recruiting | Salt Lake City | Utah | 84124 | United States |
|
| University of Washington / Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
|
| ThedaCare Regional Cancer Center | Recruiting | Appleton | Wisconsin | 54911 | United States |
|
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
Not provided
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