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Minimal Residual Disease Testing for the Early Detection of Cancer Recurrence in Resectable Stage II-IV Colorectal Cancer Patients
NCT07125729 · City of Hope Medical Center
In plain English
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Official title
ctDNA Testing in Resectable Stage II-IV Colorectal Cancer Patients: A Head-to-Head Performance Comparison
About this study
PRIMARY OBJECTIVE:
I. To compare the clinical performance of the Haystack MRD test and the Signatera® test in patients with stage II-IV CRC patients treated with curative intent surgery with or without adjuvant therapy.
SECONDARY OBJECTIVE:
I. To calculate the lead time (months) of recurrence detection by the Haystack MRD test in curatively resected colorectal cancer patients to 1) radiological recurrence time 2) Signatera® test positivity.
EXPLORATORY OBJECTIVE:
I. To explore the performance of up to two cancer detection assays (BestSEEK and enACT) in development by Dr. Tomasetti at City of Hope - Translational Genomics Research Institute (TGen) and City of Hope.
OUTLINE:
Patients undergo archival tissue and blood sample collection and Haystack MRD and Signatera circulating tumor deoxyribonucleic acid (ctDNA)/cell-free deoxyribonucleic acid (cfDNA) testing prior to standard of care (SOC) surgical resection. Patients then undergo blood sample collection and Haystack MRD and Signatera ctDNA/cfDNA testing 3-10 weeks after surgery, every 3 months for 2 years post-surgery, and then every 6 months for years 3-5 post-surgery in the absence of disease progression.
Eligibility criteria
Inclusion Criteria:
* Documented written informed consent of the participant
* Age: ≥ 18 years
* Diagnosis of stage II, III or IV colorectal cancer (any gender) if enrolled post-operatively. If a treatment naïve patient is enrolled pre-operatively and determined to be pathological stage I, the patient will be replaced
* Patient who are to undergo a curative intent surgery or have undergone a curative resection and are presenting for surveillance
* Patient identified as an appropriate candidate for Signatera® testing as a standard of care MRD surveillance assay
* Patient willingness to continue Signatera® assay every 3 months for 2 years in the first 2 years after resection and every 6 months for years 3, 4, 5 after resection, as performed by standard of care testing. In addition, the patients should be willing to provide blood samples for Haystack MRD testing at the same intervals of Signatera®, along with willingness to allow access to archival tissue to allow for Haystack MRD assay personalization. Surveillance with ctDNA should be initiated between 3 to 10 weeks from surgery
* Adequate availability of archival tissue or anticipated pathological viable tissue. All untreated primary resection would be expected to have adequate tissue. Patients with resected metastatic disease should have either previously resected primary that is amenable for tumor informed MRD testing or should have adequate archival metastasectomy samples
* Patients with total neoadjuvant therapy (TNT) for rectal cancer and complete clinical response with plans of watchful waiting may also be enrolled as long as there is adequate tissue from prior endoscopic biopsies to allow for Signatera® and Haystack MRD assays
Exclusion Criteria:
* Inability to safely provide sequential blood samples
* Clinical evidence of unresected metastatic disease
* Inability to give informed consent
Study design
Enrollment target: 150 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-12
Estimated completion: 2028-01-09
Last updated: 2025-08-15
Interventions
Procedure: Biospecimen CollectionOther: cfDNA or ctDNA MeasurementOther: Electronic Health Record Review
Primary outcomes
- • Minimal residual disease (MRD) rate with Haystack and Signatera® (Up to 5 years)
Sponsor
City of Hope Medical Center · other
With: National Cancer Institute (NCI)
Contacts & investigators
InvestigatorMarwan G Fakih · principal_investigator, City of Hope Medical Center
All locations (13)
CTCA at Western Regional Medical CenterRecruiting
Goodyear, Arizona, United States
City of Hope CoronaRecruiting
Corona, California, United States
City of Hope Comprehensive Cancer CenterRecruiting
Duarte, California, United States
City of Hope SeacliffRecruiting
Huntington Beach, California, United States
City of Hope at Irvine LennarRecruiting
Irvine, California, United States
City of Hope Antelope ValleyRecruiting
Lancaster, California, United States
City of Hope at Long Beach ElmRecruiting
Long Beach, California, United States
City of Hope at Newport Beach Fashion IslandRecruiting
Newport Beach, California, United States
City of Hope South PasadenaRecruiting
South Pasadena, California, United States
City of Hope South BayRecruiting
Torrance, California, United States
City of Hope UplandRecruiting
Upland, California, United States
City of Hope Atlanta Cancer CenterRecruiting
Newnan, Georgia, United States
City of Hope at ChicagoRecruiting
Zion, Illinois, United States