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CompletedNot applicableNCT02948946
Official study title

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

Study 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).

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNETest

The study team can explain what participation involves.

Who it may be forGastroenteropancreatic Neuroendocrine Tumor · Lung Neuroendocrine Neoplasm

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 4, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?H. Lee Moffitt Cancer Center and Research Institute

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Interventions being studied
Procedure: NETest
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 4, 2021. Always confirm current availability with the study team.

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