Appendiceal CancerNCT07587268
Molecular Profiling for Risk Stratification in Appendiceal Cancer
An observational study of Appendiceal Cancer and Appendiceal Adenocarcinoma, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This study investigates integrated epigenetic and epitranscriptomic features of appendiceal cancer using archived tumor tissue specimens from the same patient cohort. The study includes DNA methylation profiling and m6A epitranscriptomic profiling to define molecular subtypes, evaluate associations with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendiceal Cancer, Appendiceal Adenocarcinoma
- What is being tested?
- DNA Methylation Profiling and m6A Epitranscriptomic Profiling
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 1 Jan 2027
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adult patients with appendiceal cancer whose archived tumor specimens and associated clinicopathologic data are available for retrospective molecular profiling. The same patient cohort is used for DNA methylation and m6A epitranscriptomic analyses where sufficient biospecimen material is available. Benign or normal appendix tissue specimens may be included as non-malignant reference controls.
Who may be able to join
- Patients with histologically confirmed appendiceal adenocarcinoma or appendiceal cancer.
- Availability of archived tumor tissue suitable for molecular profiling.
- Availability of tissue for DNA methylation profiling, m6A epitranscriptomic profiling, or both.
- Availability of relevant clinicopathologic data.
- Availability of survival or follow-up information when applicable.
- Age 18 years or older at diagnosis or tissue collection.
Who cannot join
- Insufficient tissue quantity or quality for molecular profiling.
- Inadequate DNA or RNA quality for sequencing or molecular assay preparation.
- Missing essential clinicopathologic information required for analysis.
- Non-appendiceal primary tumor or metastatic tumor to the appendix from another primary site.
- Patients who do not meet institutional review board or consent requirements, if applicable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Durate, California, 91016
Ajay Goel, MD, 6262184673, ajgoel@coh.org
About this study
Official title: Molecular Profiling for Tumor Characterization and Risk Stratification in Patients With Appendiceal Cancer
This study investigates integrated epigenetic and epitranscriptomic features of appendiceal cancer using archived tumor tissue specimens from the same patient cohort. The study includes DNA methylation profiling and m6A epitranscriptomic profiling to define molecular subtypes, evaluate associations with clinicopathologic features, and develop molecular risk scores for prognostic stratification. The primary goal is to determine whether DNA methylation- and m6A-based molecular features can complement conventional histopathologic grading and improve risk stratification.
Read the detailed description
Appendiceal cancer is a rare and heterogeneous malignancy with limited clinically actionable biomarkers for risk stratification. Histologic grade remains one of the strongest determinants of prognosis, but outcomes among patients with lower-grade disease remain variable. This study is designed to characterize the molecular architecture of appendiceal cancer through integrated analysis of DNA methylation and m6A epitranscriptomic profiles generated from archived tumor tissue specimens from the same patient cohort.
The study uses formalin-fixed paraffin-embedded appendiceal cancer tissues, and where available benign or normal appendix tissues, together with matched clinicopathologic and follow-up data. DNA methylation profiling is performed to evaluate tumor-associated methylation patterns, identify differentially methylated regions or features, and assess their association with clinical and survival outcomes. In parallel, m6A epitranscriptomic profiling is performed using m6A-enriched RNA sequencing with matched input RNA sequencing to quantify transcriptome-wide m6A enrichment.
Molecular data are analyzed to identify tumor-associated epigenetic and epitranscriptomic alterations, define molecular subtypes, and construct continuous molecular risk scores. These molecular features are evaluated in relation to histologic grade, histologic subtype, lymph node metastasis, lymphovascular invasion, perineural invasion, peritoneal cancer index, overall survival, and progression-free survival.
The study aims to determine whether DNA methylation and m6A-based profiling can provide complementary molecular information for appendiceal cancer classification, prognostic modeling, and future biomarker development.
- Conditions
- Appendiceal Cancer, Appendiceal Adenocarcinoma
- Being tested
- DNA Methylation Profiling, m6A Epitranscriptomic Profiling
- Keywords
- Appendiceal cancer, Appendiceal adenocarcinoma, DNA methylation, m6A modification, Multi-omics, MeRIP-seq, Histologic grade;, Epigenomics, Epitranscriptomics, Molecular subtype, Risk stratification, Prognostic biomarker
- Medical subject headings
- Appendiceal Neoplasms, Adenocarcinoma, Mucinous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA Methylation ProfilingDiagnostic test
Archived tissue specimens undergo DNA methylation profiling to characterize tumor-associated methylation alterations and identify methylation-based molecular features associated with clinicopathologic variables and survival outcomes. The profiling is performed for research purposes only and does not assign treatment.
m6A Epitranscriptomic ProfilingDiagnostic test
Archived tissue specimens undergo m6A methylated RNA immunoprecipitation sequencing with matched input RNA sequencing to quantify transcriptome-wide m6A enrichment. The resulting molecular data are used for subtype discovery, m6A score construction, reduced-panel development, and association with clinicopathologic and survival outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Appendiceal Cancer Cohort | Patients with histologically confirmed appendiceal cancer whose archived tumor tissue specimens and clinicopathologic data are available for integrated DNA methylation and m6A epitranscriptomic profiling. Receives: Diagnostic Test: DNA Methylation Profiling; Diagnostic Test: m6A Epitranscriptomic Profiling | |
| Benign Appendix Reference Cohort | Individuals with benign or normal appendix tissue specimens used as non-malignant reference samples for comparison of tumor-associated DNA methylation and m6A epitranscriptomic features. Receives: Diagnostic Test: DNA Methylation Profiling; Diagnostic Test: m6A Epitranscriptomic Profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival will be evaluated in relation to molecular profiling results and available clinicopathologic characteristics. Survival analyses may include Kaplan-Meier analysis and Cox proportional hazards models
Measured: Through study completion, an average of 1 year
Progression-Free Survival
Progression-free survival will be evaluated in relation to molecular profiling results and available clinicopathologic characteristics. Time-to-event analyses may be performed using standard survival analysis methods.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 May 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendiceal CancerStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587268
- Sponsor's protocol ID
- 23228_CIPHER-AC
- Status last verified
- Jun 2026
- First submitted
- 4 May 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Profiling for Tumor Characterization and Risk Stratification in Patients With Appendiceal Cancer
- ClinicalTrials.gov ID
- NCT07587268
- Acronym / sponsor ID
- 23228_CIPHER-AC
- Conditions
- Appendiceal Cancer, Appendiceal Adenocarcinoma
- Keywords
- Appendiceal cancer, Appendiceal adenocarcinoma, DNA methylation, m6A modification, Multi-omics, MeRIP-seq, Histologic grade;, Epigenomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 14 May 2026 (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 study investigates integrated epigenetic and epitranscriptomic features of appendiceal cancer using archived tumor tissue specimens from the same patient cohort. The study includes DNA methylation profiling and m6A epitranscriptomic profiling to define molecular subtypes, evaluate associations with clinicopathologic features, and develop molecular risk scores for prognostic stratification. The primary goal is to determine whether DNA methylation- and m6A-based molecular features can complement conventional histopathologic grading and improve risk stratification.
Detailed description
Appendiceal cancer is a rare and heterogeneous malignancy with limited clinically actionable biomarkers for risk stratification. Histologic grade remains one of the strongest determinants of prognosis, but outcomes among patients with lower-grade disease remain variable. This study is designed to characterize the molecular architecture of appendiceal cancer through integrated analysis of DNA methylation and m6A epitranscriptomic profiles generated from archived tumor tissue specimens from the same patient cohort.
The study uses formalin-fixed paraffin-embedded appendiceal cancer tissues, and where available benign or normal appendix tissues, together with matched clinicopathologic and follow-up data. DNA methylation profiling is performed to evaluate tumor-associated methylation patterns, identify differentially methylated regions or features, and assess their association with clinical and survival outcomes. In parallel, m6A epitranscriptomic profiling is performed using m6A-enriched RNA sequencing with matched input RNA sequencing to quantify transcriptome-wide m6A enrichment.
Molecular data are analyzed to identify tumor-associated epigenetic and epitranscriptomic alterations, define molecular subtypes, and construct continuous molecular risk scores. These molecular features are evaluated in relation to histologic grade, histologic subtype, lymph node metastasis, lymphovascular invasion, perineural invasion, peritoneal cancer index, overall survival, and progression-free survival.
The study aims to determine whether DNA methylation and m6A-based profiling can provide complementary molecular information for appendiceal cancer classification, prognostic modeling, and future biomarker development.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Appendiceal Cancer Cohort | – | Diagnostic Test: DNA Methylation Profiling, Diagnostic Test: m6A Epitranscriptomic ProfilingPatients with histologically confirmed appendiceal cancer whose archived tumor tissue specimens and clinicopathologic data are available for integrated DNA methylation and m6A epitranscriptomic profiling. |
| Benign Appendix Reference Cohort | – | Diagnostic Test: DNA Methylation Profiling, Diagnostic Test: m6A Epitranscriptomic ProfilingIndividuals with benign or normal appendix tissue specimens used as non-malignant reference samples for comparison of tumor-associated DNA methylation and m6A epitranscriptomic features. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients with appendiceal cancer whose archived tumor specimens and associated clinicopathologic data are available for retrospective molecular profiling. The same patient cohort is used for DNA methylation and m6A epitranscriptomic analyses where sufficient biospecimen material is available. Benign or normal appendix tissue specimens may be included as non-malignant reference controls.
Key inclusion criteria (6 listed)
- Patients with histologically confirmed appendiceal adenocarcinoma or appendiceal cancer.
- Availability of archived tumor tissue suitable for molecular profiling.
- Availability of tissue for DNA methylation profiling, m6A epitranscriptomic profiling, or both.
- Availability of relevant clinicopathologic data.
- Availability of survival or follow-up information when applicable.
Key exclusion criteria (5 listed)
- Insufficient tissue quantity or quality for molecular profiling.
- Inadequate DNA or RNA quality for sequencing or molecular assay preparation.
- Missing essential clinicopathologic information required for analysis.
- Non-appendiceal primary tumor or metastatic tumor to the appendix from another primary site.
- Patients who do not meet institutional review board or consent requirements, if applicable.
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 |
|---|---|---|
| DNA Methylation ProfilingArchived tissue specimens undergo DNA methylation profiling to characterize tumor-associated methylation alterations and identify methylation-based molecular features associated with clinicopathologic variables and survival outcomes. The profiling is performed for research purposes only and does not assign treatment. | Diagnostic test | Appendiceal Cancer Cohort, Benign Appendix Reference Cohort |
| m6A Epitranscriptomic ProfilingArchived tissue specimens undergo m6A methylated RNA immunoprecipitation sequencing with matched input RNA sequencing to quantify transcriptome-wide m6A enrichment. The resulting molecular data are used for subtype discovery, m6A score construction, reduced-panel development, and association with clinicopathologic and survival outcomes. | Diagnostic test | Appendiceal Cancer Cohort, Benign Appendix Reference Cohort |
Primary outcome
Overall Survival
Time frame: Through study completion, an average of 1 year
Overall survival will be evaluated in relation to molecular profiling results and available clinicopathologic characteristics. Survival analyses may include Kaplan-Meier analysis and Cox proportional hazards models
Progression-Free Survival
Time frame: Through study completion, an average of 1 year
Progression-free survival will be evaluated in relation to molecular profiling results and available clinicopathologic characteristics. Time-to-event analyses may be performed using standard survival analysis methods.
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 29 Jun 2026.
- Individual participant dataSharing planned: No
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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.
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 Appendiceal Cancer and Appendiceal Adenocarcinoma, 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 6 inclusion and 5 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 29 Jun 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?
Contact Ajay Goel (6262184673, ajgoel@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 29 Jun 2026.