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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-09

Study Completion Date

2020-09-15

Brief Summary

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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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Detailed Description

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Conditions

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Gastroenteropancreatic Neuroendocrine Tumor Lung Neuroendocrine Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neuroendocrine Tumor (NET) Cohort

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

NETest

Intervention Type PROCEDURE

5 mL of blood will be drawn from participants for testing.

Non-NET Cohort

Participants with histologically or cytologically proven diagnosis of any grade, any stage gastrointestinal (GI) malignancies.

NETest

Intervention Type PROCEDURE

5 mL of blood will be drawn from participants for testing.

Interventions

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NETest

5 mL of blood will be drawn from participants for testing.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes