Clinical Utility Assay as a Biomarker for Gastroenteropancreatic and Lung Neuroendocrine Tumors
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).
Checked against the public recordLast updated Aug 4, 2021 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
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.