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

NCT02948946 | Completed

• 1 other identifier: MCC-18756
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Gastroenteropancreatic Neuroendocrine Tumor; Lung Neuroendocrine Neoplasm

Keywords

lung cancer; pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Rate of Successful Test Results Per Cohort

  Investigators have designed the study to test the null hypothesis that the NETest has a sensitivity and specificity of 70% or less in NET patients. The sample size calculation has been based on the assumption that a sensitivity and specificity of greater than 90% would generate further interest in the test for unselected NET patients. Power and type 1 error will be 99% and 5% respectively. Under this model, 80 or more positive tests in the cohort of 100 patients with NETs would lead to the rejection of the null hypothesis, suggesting that the NETest is sensitive. Likewise, 80 or more negative tests in 100 patients without NETs will suggest that NETest is specific. An interim analysis will be performed to rule out the futility of the NETest. Futility will be defined as a rate of false positive or false negative \>25%. Hence, if 12 or more false positives or negatives are observed among the first 50 participants, the study will be suspended, pending review by the investigators.

  12 months

Study Arms (2)

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.

Procedure: NETest

Non-NET Cohort

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

Procedure: NETest

Interventions

NETest PROCEDURE

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

Neuroendocrine Tumor (NET) Cohort; Non-NET Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants to be enrolled in the study will be recruited within the Gastrointestinal (GI) Clinic of Moffitt Cancer Center.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor; Lung Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Jonathan Strosberg, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: October 31, 2016
• Study Start: January 9, 2017
• Primary Completion: August 24, 2018
• Study Completion: September 15, 2020
• Last Updated: August 4, 2021

Record last verified: 2021-07

Locations

US (1)