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Minimal Residual Disease Testing for the Early Detection of Cancer Recurrence in Resectable Stage II-IV Colorectal Cancer Patients

RecruitingNAAges 18 Years - anyAllCity of Hope Medical Center
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In plain words

What the trial is, and whether it could suit you

This clinical trial compares minimal residual disease (MRD) testing with the Haystack blood test (assay) to the Signatera® assay for the early detection of the cancer returning (cancer recurrence) in patients with stage II-IV colorectal cancer (CRC) that can be removed by surgery (resectable). MRD testing looks for evidence of remaining tumor following treatment that is only apparent using highly sensitive techniques. There are few effective tools available outside of imaging to identify CRC patients with MRD who may be at the highest risk for cancer recurrence after surgery. Early detection of CRC recurrence after surgery is important, as it may increase the chance of curative (ability to cure) outcomes for patients with cancer recurrence. Currently, the Signatera assay is used to monitor whether CRC recurs after surgery, however it is not a very sensitive test. Early work with the Hays

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📋 Eligibility rules (as published)
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
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What it tests

  • Biospecimen Collection
  • cfDNA or ctDNA Measurement
  • Electronic Health Record Review
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Where

13 sites
CTCA at Western Regional Medical Center
Goodyear, United States
City of Hope Corona
Corona, United States
City of Hope Comprehensive Cancer Center
Duarte, United States
City of Hope Seacliff
Huntington Beach, United States
City of Hope at Irvine Lennar
Irvine, United States
City of Hope Antelope Valley
Lancaster, United States
City of Hope at Long Beach Elm
Long Beach, United States
City of Hope at Newport Beach Fashion Island
Newport Beach, United States

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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