Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2021-04-30

Brief Summary

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Prospective study to obtain fresh tumor biopsies and three blood samples from patients with a confirmed histological or cytological diagnosis of well-differentiated neuroendocrine tumors (NETs) or well-differentiated pancreatic neuroendocrine tumors (PanNETs) for molecular profiling.

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Detailed Description

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In this prospective study the aim is to obtain fresh tumor biopsies and three blood samples from patients with a confirmed histological or cytological diagnosis of well-differentiated neuroendocrine tumors (NETs) or well-differentiated pancreatic neuroendocrine tumors (PanNETs). Eligible population includes: NETs and PanNETs patients who have undergone or are undergoing treatment with targeted therapies and have shown prolonged clinical benefit, and NETs and PanNETs patients who have been treated with these agents and just recently progressed. RNA and DNA from fresh tumor biopsies and from mononuclear blood cells will be subjected to transcriptome sequencing and DNA sequencing analyses to evaluate possible genes of interest and related targetable pathways. Moreover, archived tumor samples will be requested from all patients to perform additional genomic testing. Remaining RNA and DNA will be banked for additional exploratory analyses (e.g. further genomic testing, or DNA copy number analysis, or epigenetic evaluations).

Conditions

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Neuroendocrine Tumors Pancreatic Neuroendocrine Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neuroendocrine tumors (NETs)

Eligible consenting patients will undergo one-time biopsy, during which at least 3 tumors' core samples (total length of at least 6 cm) will be collected. Core tumor biopsies and 3 vials of whole blood and archived tumor specimens will be obtained for genomic testing analysis.

No interventions assigned to this group

panNETs

Eligible consenting patients will undergo one-time biopsy, during which at least 3 tumors' core samples (total length of at least 6 cm) will be collected. Core tumor biopsies and 3 vials of whole blood and archived tumor specimens will be obtained for genomic testing analysis.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years.
* Histological or cytological proof of NETs or PanNETs.
* At least one biopsiable lesion deemed medically accessible and safe to biopsy.
* Current/recent treatment with targeted therapies with confirmed clinical benefit; confirmed progression disease to targeted therapies at the time of study enrollment.
* Fulfills local institution's laboratory parameters for tumor biopsy.
* Willingness and ability of patient to provide signed voluntary informed consent.

Exclusion Criteria

* Any condition that could interfere with their ability to provide informed consent such as dementia or severe cognitive impairment.
* Any contraindication to undergoing a biopsy or blood collection procedure.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No