Clinical trial · Observational
Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Pancreatic Cancer
NCT07528430CI-TRIAL-00119780not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research study is to test a new process for diagnosing pancreatic cancer by examining changes to your DNA that can be detected from a blood test. The information we learn by doing this study could potentially help people in the future. Participants in this study will have blood samples collected, have their medical records reviewed by study personnel and fill out questionnaires at different time points during the study. Blood sample collection will occur during normal routine clinic visits. Participation in this study will last approximately 5 years.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer, Advanced or Metastatic | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Study Population 1
- description
- This study population will consist of individuals who have a diagnosis of pancreatic cancer and have not received chemotherapy treatment for their pancreatic cancer. Individuals who have received surgical resection and/or radiation therapy for their pancreatic cancer will be included.
- label
- Study Population 2
- description
- This study population will consist of individuals who have a diagnosis of pancreatic cancer and have received chemotherapy treatment for their pancreatic cancer. All stages of pancreatic cancer will be included including individuals in remission.
- label
- Study Population 3
- description
- This study population will consist of individuals who are at high risk of developing pancreatic cancer.
Primary outcomes (3)
- measure
- Identification of tumor-associated host methylation signature
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years old or older * Patient of UMMS * Willing and able to consent to study procedures listed in the protocol * Ability to speak and understand English * Has a history of pancreatic cancer of is at high risk for pancreatic cancer Exclusion Criteria: * Younger than 18 years old * Patient not cared for at UMMS * Unable to consent to study procedures listed in the protocol * Unable to speak or understand English * Does not have a history of pancreatic cancer or is not at high risk for pancreatic cancer
References
Publications (6)
- BACKGROUNDLi Y, Fan Z, Meng Y, Liu S, Zhan H. Blood-based DNA methylation signatures in cancer: A systematic review. Biochim Biophys Acta Mol Basis Dis. 2023 Jan 1;1869(1):166583. doi: 10.1016/j.bbadis.2022.166583. Epub 2022 Oct 18. PMID 36270476
- BACKGROUNDTerp SK, Stoico MP, Dybkaer K, Pedersen IS. Early diagnosis of ovarian cancer based on methylation profiles in peripheral blood cell-free DNA: a systematic review. Clin Epigenetics. 2023 Feb 14;15(1):24. doi: 10.1186/s13148-023-01440-w. PMID 36788585
- BACKGROUNDIbrahim J, Peeters M, Van Camp G, Op de Beeck K. Methylation biomarkers for early cancer detection and diagnosis: Current and future perspectives. Eur J Cancer. 2023 Jan;178:91-113. doi: 10.1016/j.ejca.2022.10.015. Epub 2022 Oct 27. PMID 36427394
- BACKGROUNDGuo Y, Yin J, Dai Y, Guan Y, Chen P, Chen Y, Huang C, Lu YJ, Zhang L, Song D. A Novel CpG Methylation Risk Indicator for Predicting Prognosis in Bladder Cancer. Front Cell Dev Biol. 2021 Sep 1;9:642650. doi: 10.3389/fcell.2021.642650. eCollection 2021. PMID 34540821
- BACKGROUNDXie Y, Li P, Sun D, Qi Q, Ma S, Zhao Y, Zhang S, Wang T, Wang J, Li S, Gong T, Xu H, Xiong M, Li G, You C, Luo Z, Li J, Wang C, Du L. DNA Methylation-Based Testing in Peripheral Blood Mononuclear Cells Enables Accurate and Early Detection of Colorectal Cancer. Cancer Res. 2023 Nov 1;83(21):3636-3649. doi: 10.1158/0008-5472.CAN-22-3402. PMID 37602818
- BACKGROUNDWang T, Li P, Qi Q, Zhang S, Xie Y, Wang J, Liu S, Ma S, Li S, Gong T, Xu H, Xiong M, Li G, You C, Luo Z, Li J, Du L, Wang C. A multiplex blood-based assay targeting DNA methylation in PBMCs enables early detection of breast cancer. Nat Commun. 2023 Aug 7;14(1):4724. doi: 10.1038/s41467-023-40389-5. PMID 37550304