Clinical trial · Observational
Tempus CRC Surveillance Study: A ctDNA Biomarker Profiling Study of Patients With CRC Using NGS Assays
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
NCT05234177CI-TRIAL-00089355recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with stage I-IV colorectal cancer (CRC)
- description
- This protocol will include participants with stage I-IV CRC who are scheduled to undergo or have undergone a surgical resection with curative intent.
- interventionNames
- Other: Observation
Primary outcomes (1)
- measure
- Recurrence-Free Survival
- timeFrame
- 2 years
- description
- 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 outcomes (3)
- measure
- Sensitivity
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * 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
References
Publications (39)
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- BACKGROUNDSiegel 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. PMID 32133645
- BACKGROUNDStoffel EM, Murphy CC. Epidemiology and Mechanisms of the Increasing Incidence of Colon and Rectal Cancers in Young Adults. Gastroenterology. 2020 Jan;158(2):341-353. doi: 10.1053/j.gastro.2019.07.055. Epub 2019 Aug 5. PMID 31394082
- BACKGROUNDIslami F, Ward EM, Sung H, Cronin KA, Tangka FKL, Sherman RL, Zhao J, Anderson RN, Henley SJ, Yabroff KR, Jemal A, Benard VB. Annual Report to the Nation on the Status of Cancer, Part 1: National Cancer Statistics. J Natl Cancer Inst. 2021 Nov 29;113(12):1648-1669. doi: 10.1093/jnci/djab131. PMID 34240195
- BACKGROUNDBrenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-1502. doi: 10.1016/S0140-6736(13)61649-9. Epub 2013 Nov 11. PMID 24225001
- BACKGROUNDInstitute NC, National Cancer Institute. AJCC Cancer Staging Manual 8th Edition. Definitions. 2020
- BACKGROUNDLeufkens AM, van den Bosch MA, van Leeuwen MS, Siersema PD. Diagnostic accuracy of computed tomography for colon cancer staging: a systematic review. Scand J Gastroenterol. 2011 Jul;46(7-8):887-94. doi: 10.3109/00365521.2011.574732. Epub 2011 Apr 20. PMID 21504379
- BACKGROUNDBenson AB 3rd, Choti MA, Cohen AM, Doroshow JH, Fuchs C, Kiel K, Martin EW Jr, McGinn C, Petrelli NJ, Posey JA, Skibber JM, Venook A, Yeatman TJ; National Comprehensive Cancer Network. NCCN Practice Guidelines for Colorectal Cancer. Oncology (Williston Park). 2000 Nov;14(11A):203-12.