EpigenOMic Determinants of the Neuroendocrine Phenotype As Biomarkers for Neuroendocrine Neoplasms

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Institute of Oncology

About this trial

For GEP mixed neuroendocrine (NE) non-neuroendocrine neoplasms (MiNENs) a key issue affecting prognosis is sometimes the difficulty in obtaining a timely diagnosis, as the NE component is often localized in deeper anatomical locations and/or becomes prevalent over time. The tissue material of biopsies may be not enough to define the NE component when this is particularly small and this could impact on therapeutic decision. Furthermore GEP NENs need to be characterized for potentially druggable biomarkers and liquid biopsy has clear advantage to the solid one to this aim. Here, we will exploit epigenetic differences characterizing NE tumors to build a DNA methylation-based liquid biopsy assay able to detect circulating tumor DNA of NE derivation, to enable the non-invasive diagnosis and monitoring of GEP-MiNENs.

Eligibility criteria

Qualifiers

Patient with histologically confirmed diagnosis of NEC/MINEN amenable to surgery with radical intent

Patient with histologically confirmed diagnosis of NET amenable to surgery with radical intent

Patient with metastatic NET/NEC, amenable to biopsy or surgery, including palliative intent

Colorectal carcinoma

Disqualifiers

Grading G1 and G2 <=10% Ki67

Presence of concomitant neoplasm (within 3 years)

Concomitant major haematological alteration

Concomitant major organ dysfunction (e.g. G3/4 liver or kidney failure)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

130 Participants
are grouped into 2 trial groups

Sponsors and collaborators

European Institute of Oncology

Lead sponsor

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Collaborator