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New treatment option for Resectable Colorectal Carcinoma
Official title Minimal Residual Disease Testing for the Early Detection of Cancer Recurrence in Resectable Stage II-IV Colorectal Cancer Patients
ClinicalTrials.gov ID: NCT07125729
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- Inability to safely provide sequential blood samples
- Clinical evidence of unresected metastatic disease
- Inability to give informed consent
See the full eligibility 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...
- 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...
- 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...
- 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...
- Inability to safely provide sequential blood samples
- Clinical evidence of unresected metastatic disease
- Inability to give informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Goodyear, Arizona, United States
- Corona, California, United States
- Duarte, California, United States
- Huntington Beach, California, United States
- Irvine, California, United States
- Lancaster, California, United States
- Long Beach, California, United States
- Newport Beach, California, United States
- South Pasadena, California, United States
- Torrance, California, United States
- Upland, California, United States
- Newnan, Georgia, United States
- Zion, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Goodyear, Arizona, United States; Corona, California, United States; Duarte, California, United States; Huntington Beach, California, United States; Irvine, California, United States; Lancaster, California, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.