Colorectal Cancer (Diagnosis)epiCEDNCT07224854
Epigenetic Signature for CRC Early Detection
An observational study of Colorectal Cancer (Diagnosis) and Non-cancer Controls, run by City of Hope Medical Center at 1 site in United States.
Trial summary
The epiCED is a noninvasive blood-based assay designed for early detection of colorectal cancer (CRC) using circulating cell-free DNA (cfDNA) 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) epigenetic markers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer (Diagnosis), Non-cancer Controls, DNA Methylation
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2024to 18 Jun 2028
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Retrospective, international multi-center cohort of adults (≥18 years), including CRC patients and non-cancer controls. Blood samples and corresponding de-identified clinical data are available for discovery, model training, and multi-center validation.
Who may be able to join
- Adults aged ≥18 years at the time of sample collection.
- Patients with confirmed CRC or non-cancer controls.
- Availability of retrospective blood samples collected according to institutional protocols.
- Willingness to allow use of de-identified clinical and demographic data.
Who cannot join
- Concurrent malignancies outside the gastrointestinal tract (unless in complete remission ≥5 years).
- Samples with insufficient volume or poor cfDNA quality.
- Recent chemotherapy, radiotherapy, or major surgery within 4 weeks prior to blood collection (if prospective samples).
- Any condition precluding reliable sample analysis or participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Nat Medical Ctr
Monrovia, California, 91016
About this study
Official title: A Model of Epigenetic Biomarkers Based on cfDNA 5mC/5hmC for Early Detection of Colorectal Cancer
The epiCED is a noninvasive blood-based assay designed for early detection of colorectal cancer (CRC) using circulating cell-free DNA (cfDNA) 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) epigenetic markers. This study leverages retrospective, multi-center cohorts of CRC patients and non-cancer controls to discover and validate a robust cfDNA methylation signature. Small-scale sequencing and machine learning-based modeling will be applied to identify a minimal panel of methylation markers that can accurately discriminate CRC from non-cancer individuals, including early-stage disease. The ultimate goal is to develop a clinically practical, noninvasive screening tool that enables population-level early detection and improves patient outcomes.
Read the detailed description
The epiCED is a noninvasive, blood-based approach aimed at early detection of colorectal cancer (CRC) using circulating cell-free DNA (cfDNA) 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) epigenetic markers. Early detection of CRC is critical for improving patient outcomes, but current diagnostic tools-including colonoscopy, CT, and MRI-are either invasive, costly, or insufficiently sensitive for early-stage disease, limiting their use for population-wide screening.
This study will utilize retrospective, multi-center cohorts comprising adult participants (≥18 years) with confirmed CRC and non-cancer controls, including healthy volunteers and individuals with benign gastrointestinal conditions. Blood samples will be subjected to cfDNA extraction and small-scale epigenetic sequencing to profile 5mC and 5hmC patterns.
During the discovery phase, differential methylation analysis and machine learning-based feature selection will be applied to identify a minimal set of cfDNA methylation markers that optimally discriminate CRC from non-cancer individuals. In the training and validation phase, the identified signature will be evaluated across independent international multi-center cohorts to ensure reproducibility, robustness, and early-stage detection performance.
The primary objectives are to:
- Develop a cfDNA methylation panel capable of accurately distinguishing CRC patients from non-cancer controls.
- Validate the panel's ability to detect early-stage CRC.
- Secondary objectives include evaluating the association of the methylation signature with clinical parameters, tumor stage, and demographic factors. By integrating high-resolution cfDNA methylation profiling with advanced computational modeling, epiCED aims to provide a scalable, cost-effective, and clinically practical tool for noninvasive early detection of colorectal cancer.
- Conditions
- Colorectal Cancer (Diagnosis), Non-cancer Controls, DNA Methylation, Cell Free DNA, Early Detection of Cancer
- Keywords
- noninvasive screening, circulating cfDNA, 5mC, 5hmC, epigenetic biomarkers, machine learning, colorectal cancer, early detection
- Medical subject headings
- Colorectal Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CRC | Adult patients with confirmed colorectal cancer from international centers. | |
| Control | Non-cancer individuals, including healthy volunteers or patients with benign gastrointestinal conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for detecting colorectal cancer
Proportion of true positive CRC cases correctly identified by the cfDNA methylation panel.
Measured: Baseline (pre-treatment blood sample collection)
Secondary outcomes (2)
Specificity for detecting colorectal cancer
Proportion of true negative (non-cancer) individuals correctly classified by the cfDNA methylation panel.
Measured: Frame: Baseline (pre-treatment blood sample collection)
Area Under the Receiver Operating Characteristic Curve (AUROC)
AUROC of the cfDNA methylation panel for distinguishing CRC patients from non-cancer controls.
Measured: Baseline (pre-treatment blood sample collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start21 Jun 2024
- Primary completion18 Jun 2028 (estimated)
- Study completion18 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer (Diagnosis)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ajay Goel, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224854
- Sponsor's protocol ID
- 23228/epiCED
- Acronym
- epiCED
- Status last verified
- Jul 2026
- First submitted
- 3 Nov 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goddard KAB, Feuer EJ, Mandelblatt JS, Meza R, Holford TR, Jeon J, Lansdorp-Vogelaar I, Gulati R, Stout NK, Howlader N, Knudsen AB, Miller D, Caswell-Jin JL, Schechter CB, Etzioni R, Trentham-Dietz A, Kurian AW, Plevritis SK, Hampton JM, Stein S, Sun LP, Umar A, Castle PE. Estimation of Cancer Deaths Averted From Prevention, Screening, and Treatment Efforts, 1975-2020. JAMA Oncol. 2025 Feb 1;11(2):162-167. doi: 10.1001/jamaoncol.2024.5381.
PubMed 39636625Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Model of Epigenetic Biomarkers Based on cfDNA 5mC/5hmC for Early Detection of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07224854
- Acronym / sponsor ID
- epiCED / 23228/epiCED
- Conditions
- Colorectal Cancer (Diagnosis), Non-cancer Controls, DNA Methylation, Cell Free DNA, Early Detection of Cancer
- Keywords
- noninvasive screening, circulating cfDNA, 5mC, 5hmC, epigenetic biomarkers, machine learning, colorectal cancer, early detection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 18 Jun 2028 (estimated)
- Study completion
- 18 Jun 2028 (estimated)
- First posted
- 5 Nov 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.
The epiCED is a noninvasive blood-based assay designed for early detection of colorectal cancer (CRC) using circulating cell-free DNA (cfDNA) 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) epigenetic markers. This study leverages retrospective, multi-center cohorts of CRC patients and non-cancer controls to discover and validate a robust cfDNA methylation signature. Small-scale sequencing and machine learning-based modeling will be applied to identify a minimal panel of methylation markers that can accurately discriminate CRC from non-cancer individuals, including early-stage disease. The ultimate goal is to develop a clinically practical, noninvasive screening tool that enables population-level early detection and improves patient outcomes.
Detailed description
The epiCED is a noninvasive, blood-based approach aimed at early detection of colorectal cancer (CRC) using circulating cell-free DNA (cfDNA) 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) epigenetic markers. Early detection of CRC is critical for improving patient outcomes, but current diagnostic tools-including colonoscopy, CT, and MRI-are either invasive, costly, or insufficiently sensitive for early-stage disease, limiting their use for population-wide screening.
This study will utilize retrospective, multi-center cohorts comprising adult participants (≥18 years) with confirmed CRC and non-cancer controls, including healthy volunteers and individuals with benign gastrointestinal conditions. Blood samples will be subjected to cfDNA extraction and small-scale epigenetic sequencing to profile 5mC and 5hmC patterns.
During the discovery phase, differential methylation analysis and machine learning-based feature selection will be applied to identify a minimal set of cfDNA methylation markers that optimally discriminate CRC from non-cancer individuals. In the training and validation phase, the identified signature will be evaluated across independent international multi-center cohorts to ensure reproducibility, robustness, and early-stage detection performance.
The primary objectives are to:
- Develop a cfDNA methylation panel capable of accurately distinguishing CRC patients from non-cancer controls.
- Validate the panel's ability to detect early-stage CRC.
- Secondary objectives include evaluating the association of the methylation signature with clinical parameters, tumor stage, and demographic factors. By integrating high-resolution cfDNA methylation profiling with advanced computational modeling, epiCED aims to provide a scalable, cost-effective, and clinically practical tool for noninvasive early detection of colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRC | – | –Adult patients with confirmed colorectal cancer from international centers. |
| Control | – | –Non-cancer individuals, including healthy volunteers or patients with benign gastrointestinal conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective, international multi-center cohort of adults (≥18 years), including CRC patients and non-cancer controls. Blood samples and corresponding de-identified clinical data are available for discovery, model training, and multi-center validation.
Key inclusion criteria (4 listed)
- Adults aged ≥18 years at the time of sample collection.
- Patients with confirmed CRC or non-cancer controls.
- Availability of retrospective blood samples collected according to institutional protocols.
- Willingness to allow use of de-identified clinical and demographic data.
Key exclusion criteria (4 listed)
- Concurrent malignancies outside the gastrointestinal tract (unless in complete remission ≥5 years).
- Samples with insufficient volume or poor cfDNA quality.
- Recent chemotherapy, radiotherapy, or major surgery within 4 weeks prior to blood collection (if prospective samples).
- Any condition precluding reliable sample analysis or participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity for detecting colorectal cancer
Time frame: Baseline (pre-treatment blood sample collection)
Proportion of true positive CRC cases correctly identified by the cfDNA methylation panel.
2 secondary outcomes
Specificity for detecting colorectal cancer
Time frame: Frame: Baseline (pre-treatment blood sample collection)
Area Under the Receiver Operating Characteristic Curve (AUROC)
Time frame: Baseline (pre-treatment blood sample collection)
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 7 Jul 2026.
- Background: PubMed 39636625Goddard KAB, Feuer EJ, Mandelblatt JS, Meza R, Holford TR, Jeon J, Lansdorp-Vogelaar I, Gulati R, Stout NK, Howlader N, Knudsen AB, Miller D, Caswell-Jin JL, Schechter CB, Etzioni R, Trentham-Dietz A, Kurian AW, Plevritis SK, Hampton JM, Stein S, Sun LP, Umar A, Castle PE. Estimation of Cancer Deaths Averted From Prevention, Screening, and Treatment Efforts, 1975-2020. JAMA Oncol. 2025 Feb 1;11(2):162-167. doi: 10.1001/jamaoncol.2024.5381.
- Background: PubMed 38572751Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer (Diagnosis)
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
Recruiting
Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
Cancer, Breast Cancer
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. This study is not recruiting at the moment.
Ajay Goel, PhD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer (Diagnosis) and Non-cancer Controls, run by City of Hope Medical Center at 1 site 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity for detecting colorectal cancer (time frame: Baseline (pre-treatment blood sample collection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07224854, which also lists 2 linked publications.
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 7 Jul 2026.