Clinical Trial 18756

Cancer Type: Gastrointestinal Tumor
Interventions:Not Applicable

Study Type: Diagnostic
Phase of Study: NA
Investigators:

  • Jonathan Strosberg

Overview

Study Title

The Clinical Utility of a Blood-Based Multitranscriptome Assay as a Biomarker for Gastroenteropancreatic and Lung Neuroendocrine Tumors

Summary

The purpose of this study is to evaluate how well an investigational blood test performs. The study will look at the sensitivity and specificity of a blood-based multitranscriptome assay (NETest). Participants to be enrolled in the study will be recruited within the Gastrointestinal (GI) Clinic of Moffitt Cancer Center.

Objective

The primary objective of this project is: To determine the performance metrics (sensitivity, specificity) of NETest in a real-world heterogenous cohort of NET patients. The secondary objectives of this project are: Evaluate and compare the performance metrics of the NETest in pre-specified sub-cohorts of patients (G1/G2 vs G3; GI vs pNETs vs lung; ENETS stage I-III vs stage IV). Evaluate the ability of the NETest in influencing clinical decisions (when associated to other clinical, lab or imaging results).

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.