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

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Lung Neuroendocrine Neoplasm; Gastroenteropancreatic Neuroendocrine Tumor

Treatments: Procedure: NETest

Study type: Observational

Funder types: Other

Identifiers

NCT02948946

MCC-18756

Details and patient eligibility

About

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).

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

105 participants in 2 patient groups

Neuroendocrine Tumor (NET) Cohort

Description:

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.

Treatment:

Procedure: NETest

Non-NET Cohort

Description:

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

Treatment:

Procedure: NETest