EpigenOMic Determinants of the Neuroendocrine Phenotype As Biomarkers for Neuroendocrine Neoplasms

ConditionsMixed Neuroendocrine-Non Neuroendocrine Neoplasm Neuroendocrine Neoplasm

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

This trial does not accept healthy volunteers

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 population

Patients with GEP-NENs, aiming to collect adequate material and for a formal clinical to establish sensitivity and specificity of the assay in a clinically meaningful scenario. Due to the relative rarity of the disease compared to non-NENs we will not enroll a consecutive population, but we will set up a case-control study: * Cases: patients with resectable, histologically confirmed NENs * Controls: patients with resectable, histologically confirmed non-neuroendocrine gastrointestinal tumors (including gastric, pancreatic, colorectal, small intestine). Patients will be enrolled as cases or controls based on their pre-surgical diagnostic biopsy but will be definitively allocated in the case or control group based on their post-surgery full histological examination.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

130 Participants

are grouped into 2 trial groups

Group A: Neuroendocrine neoplasm case

Group B: Non-neuroendocrine neoplasm control

Trial outcomes

Primary outcomes

Develop a circulating methDNA/fragmentomics diagnostic assay

Epigenetic differences characterizing neuroendocrine tumors will be exploited to build a DNA methylation-based liquid biopsy assay able to detect circulating tumor DNA of neuroendocrine derivation, to enable the non-invasive diagnosis and monitoring of GEP-MiNENs.

Time frame

2 years

Sponsors and contacts

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European Institute of Oncology

Lead sponsor

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Collaborator

Source ClinicalTrials.gov

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