Clinical trial NCT02586844: Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors
Official title: Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumors
Keywords: NET
PanNET
Molecular profiling
Transcriptome sequencing
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2015-10-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with histological or cytological diagnosis of NET and PanNET; have at least one biopsiable lesion deemed medically accessible and safe to biopsy; fulfill local institution's laboratory parameters for tumor biopsy, and provided written voluntary informed consent.

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: To prospectively collect tumor tissue and blood sample from patients with carcinoid tumors and islet cell tumors.
timeFrame: 3 years
Secondary outcomes:
measure: To evaluate gene alterations differences between carcinoid tumors and islet cell tumors.
timeFrame: 3 years
measure: To correlate genomic findings with treatment and clinical outcome.
timeFrame: 3 years
measure: To compare acquired data with existent available databases of whole genome or exome of neuroendocrine tumors
timeFrame: 3 years
measure: To bank remaining samples for additional exploratory analyses (e.g. further genomic testing, or DNA copy number analysis, or epigenetic evaluations).
timeFrame: 3 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Lillian Siu, MD
role: PRINCIPAL_INVESTIGATOR
References: