Status:
COMPLETED
Next Generation Sequencing-Based Stratification of Front Line Treatment of HighGrade Neuroendocrine Carcinoma
Lead Sponsor:
Charles Kunos
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Large-Cell Neuroendocrine Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
PRECISION-NEC is a single-center, open-label, pilot feasibility study of molecularly defined subtypes of metastatic high-grade neuroendocrine carcinoma (HG-NEC). The hypothesis is that HG-NEC (excludi...
Detailed Description
Neuroendocrine tumors vary widely in both disease site and grade, ranging from low grade, relatively benign carcinoid tumors to aggressive and rapidly fatal high-grade neuroendocrine carcinomas. High-...
Eligibility Criteria
Inclusion
- Histologically confirmed high grade neuroendocrine carcinoma that is metastatic and/or not resectable
- Adequate tissue available for genomic sequencing
- ECOG status less than or equal to 2
- Able to consent
- Patient received up to two cycles of chemotherapy prior to enrollment
- Adequate bone marrow function
- Adequate hepatic function
- Adequate renal function
Exclusion
- Small cell carcinoma
- Psychiatric illness or social situations that limit compliance
- Pregnant and nursing women
- Patients who have completed more than two cycles of chemotherapy
- Patients with resectable cancer or eligible for curative therapy
- Patients with an actionable mutation for with guidelines recommend up-front therapy with targeted agents
Key Trial Info
Start Date :
September 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04452292
Start Date
September 14 2021
End Date
March 14 2023
Last Update
May 17 2023
Active Locations (1)
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1
Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States, 40536