Resectable Colorectal CarcinomaNCT07125729
Minimal Residual Disease Testing for the Early Detection of Cancer Recurrence in Resectable Stage II-IV Colorectal Cancer Patients
A study testing Biospecimen Collection, cfDNA or ctDNA Measurement and Electronic Health Record Review in people with Resectable Colorectal Carcinoma and Stage II Colorectal Cancer AJCC v8, run by City of Hope Medical Center at 13 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Colorectal Carcinoma, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, cfDNA or ctDNA Measurement and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 13 sitesUnited States
- Study dates
- 29 Aug 2025to 9 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to safely provide sequential blood samples
- Clinical evidence of unresected metastatic disease
- Inability to give informed consent
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
City of Hope Corona
Corona, California, 92882
Marwan G. Fakih, 626-613-5025, mfakih@coh.org
Marwan G. Fakih
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Marwan G. Fakih, 626-613-5025, mfakih@coh.org
Marwan G. Fakih
- Recruiting
CTCA at Western Regional Medical Center
Goodyear, Arizona, 85338
Marwan G. Fakih, 626-613-5025, mfakih@coh.org
Marwan G. Fakih
- Recruiting
City of Hope Seacliff
Huntington Beach, California, 92648
Marwan G. Fakih, 626-613-5025, mfakih@coh.org
Marwan G. Fakih
- Recruiting
City of Hope at Irvine Lennar
Irvine, California, 92618
Marwan G. Fakih, 626-613-5025, mfakih@coh.org
Marwan G. Fakih
- Recruiting
City of Hope Antelope Valley
Lancaster, California, 93534
Marwan G. Fakih, 626-613-5025, mfakih@coh.org
Marwan G. Fakih
- Recruiting
City of Hope at Long Beach Elm
Long Beach, California, 90813
Marwan G. Fakih, 626-613-5025, mfakih@coh.org
Marwan G. Fakih
- Recruiting
City of Hope Atlanta Cancer Center
Newnan, Georgia, 30265
Marwan G. Fakih, 626-613-5025, mfakih@coh.org
Marwan G. Fakih
- Recruiting
City of Hope at Newport Beach Fashion Island
Newport Beach, California, 92660
Marwan G. Fakih, 626-613-5025, mfakih@coh.org
Marwan G. Fakih
- Recruiting
City of Hope South Pasadena
South Pasadena, California, 91030
Marwan G. Fakih, 626-613-5025, mfakih@coh.org
Marwan G. Fakih
- Recruiting
City of Hope South Bay
Torrance, California, 90503
Marwan G. Fakih, 626-613-5025, mfakih@coh.org
Marwan G. Fakih
- Recruiting
City of Hope Upland
Upland, California, 91786
Marwan G. Fakih, 626-613-5025, mfakih@coh.org
Marwan G. Fakih
- Recruiting
City of Hope at Chicago
Zion, Illinois, 60099
Marwan G. Fakih, 626-613-5025, mfakih@coh.org
Marwan G. Fakih
About this study
Official title: ctDNA Testing in Resectable Stage II-IV Colorectal Cancer Patients: A Head-to-Head Performance Comparison
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 Haystack assay suggests it may be more sensitive than the Signatera assay, which may be more effective for the early detection of cancer recurrence in patients with resectable stage II-IV CRC.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- Conditions
- Resectable Colorectal Carcinoma, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8
- Being tested
- Biospecimen Collection, cfDNA or ctDNA Measurement, Electronic Health Record Review
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo archival tissue and/or blood sample collection
cfDNA or ctDNA MeasurementOther
Also called Cell-Free DNA/Circulating Tumor DNA Measurement, cfDNA/ctdDNA Measurement, cfDNA/ctDNA, cfDNA/ctDNA Measurement
Undergo Haystack MRD and Signatera ctDNA/cfDNA testing
Electronic Health Record ReviewOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Screening (Haystack MRD, Signatera) | Experimental | Patients undergo archival tissue and blood sample collection and Haystack MRD and Signatera ctDNA/cfDNA testing prior 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. Receives: Procedure: Biospecimen Collection; Other: cfDNA or ctDNA Measurement; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal residual disease (MRD) rate with Haystack and Signatera®
Will assess the MRD rate with Haystack (positive circulating tumor deoxyribonucleic acid [+ctDNA] and negative imaging) versus MRD rate with Signatera (+ctDNA and negative imaging). Sensitivity (i.e., true positive rate - proportion of patients who recur that are found to be MRD positive), specificity (i.e., true negative rate - proportion of patients who do NOT recur that are found to be MRD negative), positive predictive value (i.e., proportion of positive tests which are true positives) and negative predictive value (proportion of negative tests which are true negatives) of the Haystack test and of the Signatera test for predicting disease recurrence will be calculated and summarized at various times of testing.
Measured: Up to 5 years
Secondary outcomes (2)
Time interval of detection of disease recurrence by Haystack test, radiological imaging, and Signatera test
The time interval between recurrence detection by the Haystack MRD test compared to radiological imaging assessment and Signatera test will be calculated as the time interval between the detection of disease recurrence by each of the methods (Haystack test, radiological imaging, Signatera test). Lead-time will be estimated by means of appropriate formulas and Monte Carlo simulation. Pairwise comparisons of detection times will be performed using the log-rank test. Cox proportional hazards model will be used to estimate the hazard ratios and 95% confidence intervals for each detection method.
Measured: Up to 5 years
Level of association of circulating tumor deoxyribonucleic acid (ctDNA) result and status of recurrence and non-recurrence
Logistic regression model will be used to estimate the level of association of ctDNA result and the status of recurrence and non- recurrence in patients with resectable stage II-IV colorectal cancer. Multivariable models adjusting for relevant clinical variables will be evaluated to assess the importance of these prognostic factors and support the robustness of ctDNA findings.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start29 Aug 2025
- Primary completion9 Jan 2028 (estimated)
- Study completion9 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Marwan G Fakih, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125729
- Sponsor's protocol ID
- 24372
- Other IDs
- NCI-2025-05428, 24372, P30CA033572
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ctDNA Testing in Resectable Stage II-IV Colorectal Cancer Patients: A Head-to-Head Performance Comparison
- ClinicalTrials.gov ID
- NCT07125729
- Acronym / sponsor ID
- 24372
- Conditions
- Resectable Colorectal Carcinoma, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- 9 Jan 2028 (estimated)
- Study completion
- 9 Jan 2028 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Haystack assay suggests it may be more sensitive than the Signatera assay, which may be more effective for the early detection of cancer recurrence in patients with resectable stage II-IV CRC.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (Haystack MRD, Signatera) | Experimental | Procedure: Biospecimen Collection, Other: cfDNA or ctDNA Measurement, Other: Electronic Health Record ReviewPatients undergo archival tissue and blood sample collection and Haystack MRD and Signatera ctDNA/cfDNA testing prior 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Inability to safely provide sequential blood samples
- Clinical evidence of unresected metastatic disease
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo archival tissue and/or blood sample collection | Procedure or surgery | Screening (Haystack MRD, Signatera) |
| cfDNA or ctDNA MeasurementAlso: Cell-Free DNA/Circulating Tumor DNA Measurement, cfDNA/ctdDNA Measurement, cfDNA/ctDNA, cfDNA/ctDNA MeasurementUndergo Haystack MRD and Signatera ctDNA/cfDNA testing | Other | Screening (Haystack MRD, Signatera) |
| Electronic Health Record ReviewAncillary studies | Other | Screening (Haystack MRD, Signatera) |
Primary outcome
Minimal residual disease (MRD) rate with Haystack and Signatera®
Time frame: Up to 5 years
Will assess the MRD rate with Haystack (positive circulating tumor deoxyribonucleic acid [+ctDNA] and negative imaging) versus MRD rate with Signatera (+ctDNA and negative imaging). Sensitivity (i.e., true positive rate - proportion of patients who recur that are found to be MRD positive), specificity (i.e., true negative rate - proportion of patients who do NOT recur that are found to be MRD negative), positive predictive value (i.e., proportion of positive tests which are true positives) and negative predictive value (proportion of negative tests which are true negatives) of the Haystack test and of the Signatera test for predicting disease recurrence will be calculated and summarized at various times of testing.
2 secondary outcomes
Time interval of detection of disease recurrence by Haystack test, radiological imaging, and Signatera test
Time frame: Up to 5 years
Level of association of circulating tumor deoxyribonucleic acid (ctDNA) result and status of recurrence and non-recurrence
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marwan G Fakih principal investigator
City of Hope Medical Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, cfDNA or ctDNA Measurement and Electronic Health Record Review in people with Resectable Colorectal Carcinoma and Stage II Colorectal Cancer AJCC v8, run by City of Hope Medical Center at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal residual disease (MRD) rate with Haystack and Signatera® (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.