Clinical Utility Assay as a Biomarker for Gastroenteropancreatic and Lung Neuroendocrine Tumors

Inclusion Criteria:

NET Cohort-

- Patients with histologically or cytologically proven diagnosis of any grade, any stage
NET of GEP or lung origin; In the first stage of the study (initial 50 patients) only
patients with stage IV, well-differentiated tumors (G1/G2) will be enrolled.

- Patients with stable or progressive disease, as documented on a scan (CT, MRI);
Progression status will be documented on case report form (CRF).

- Allowed prior therapies include: a.) Surgery (tumor surgery at least four weeks prior
to study entry); b.) Locoregional therapy such as: chemoembolization,
radio-embolization, radiofrequency ablation, radiotherapy at least six weeks prior to
study entry; c.) Any number of previous lines of systemic therapy, providing that
cytotoxic therapies (chemotherapy, PRRT) have been discontinued at least 4 weeks prior
to study entry.

Non-NET Cohort -

- Healthy participants

- Patients with histologically or cytologically proven diagnosis of any grade, any stage
GI malignancies.

Exclusion Criteria:

NET Cohort -

- Patients on treatment with cytotoxic agents (chemotherapy, PRRT).

- Patients with renal insufficiency or congestive heart failure.

- No other active malignancy within 3 years of enrolment except adequately treated basal
cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I
or II cancer from which the patient is currently in complete remission.

Non-NET Cohort

- Patients with GI malignancies with neuroendocrine differentiation.