Clinical trial · Observational
Molecular Analysis in Tissue Samples From Patients With Advanced or Metastatic Neuroendocrine Tumors
A Pilot Study Utilizing Molecular Analysis Via Cancer CodeTM to Identify Therapeutic Targets for Patients With Advanced Neuroendocrine Tumors
NCT02092714CI-TRIAL-00039655unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This pilot research trial studies molecular analysis in tissue samples from patients with advanced or metastatic neuroendocrine tumors. Studying samples of tissue from patients with neuroendocrine tumors in the lab may help doctors identify mutations to classify disease and plan the best treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumor | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-correlative (molecular analysis)
- description
- Previously collected tissue samples are analyzed via mutational sequencing and immunohistochemistry.
- interventionNames
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Feasibility, defined as the true proportion of patients whose CancerCode sequencing results in the identification of at least 1 actionable mutation
- timeFrame
- Up to 3 years
Secondary outcomes (5)
- measure
- Response rate, defined as at least a 30% decrease in target lesions when measureable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- timeFrame
- Up to 3 years
- description
- The response rate (with 95% two-sided confidence intervals) will be computed for all Arm B patients and separately for pre-specified subgroups (e.g., molecular profile-based treatment vs. NCCN guideline recommended).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically or cytologically confirmed neuroendocrine tumor which is metastatic, locally advanced or otherwise incurable (of any grade or primary site, excluding small cell lung cancers, large cell lung cancers, and Merkel cell carcinomas) * Evaluable disease by radiographic imaging * Adequate available tumor tissue (formalin-fixed paraffin-embedded \[FFPE\] tissue or cytologic material) for sequencing (containing \> 50% tumor cellularity by histopathology) or consent to tumoral biopsy for fresh tissue; adequacy will be determined by our pathology department, under supervision of Dr. Gustafson * Ability to understand and willingness to sign a written informed consent and Health Information Portability and Accountability Act (HIPAA) consent document * Life expectancy of \>= 6 months * Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2 Exclusion Criteria: * Localized neuroendocrine tumor for which the patient is eligible for a potentially curative surgical intervention * Primary diagnosis of pulmonary small cell carcinoma, pulmonary large cell carcinoma or Merkel cell carcinoma * Inability to provide informed consent * Inadequate tissue available for genetic testing * Any secondary active malignancy, excluding non-melanoma skin cancers; if the patient's prognosis will be primarily determined by their neuroendocrine tumor, the secondary malignancy is to be discounted
References
Publications (0)
Data not yet available
No reference posted for this study.