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Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors (NET-SEQ)

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ClinicalTrials.gov Identifier: NCT02586844
Recruitment Status : Active, not recruiting
First Posted : October 26, 2015
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date October 23, 2015
First Posted Date October 26, 2015
Last Update Posted Date September 25, 2019
Study Start Date October 2013
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 23, 2015)
To prospectively collect tumor tissue and blood sample from patients with carcinoid tumors and islet cell tumors. [ Time Frame: 3 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02586844 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 23, 2015)
  • To evaluate gene alterations differences between carcinoid tumors and islet cell tumors. [ Time Frame: 3 years ]
  • To correlate genomic findings with treatment and clinical outcome. [ Time Frame: 3 years ]
  • To compare acquired data with existent available databases of whole genome or exome of neuroendocrine tumors [ Time Frame: 3 years ]
  • To bank remaining samples for additional exploratory analyses (e.g. further genomic testing, or DNA copy number analysis, or epigenetic evaluations). [ Time Frame: 3 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors
Official Title Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors
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).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Fresh tumor tissue, 3 tubes of whole blood, archival tumor tissue
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.
Condition
  • Neuroendocrine Tumors
  • Pancreatic Neuroendocrine Tumors
Intervention Not Provided
Study Groups/Cohorts
  • 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.
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: March 26, 2019)
13
Original Estimated Enrollment
 (submitted: October 23, 2015)
30
Estimated Study Completion Date October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02586844
Other Study ID Numbers NET-SEQ
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Lillian Siu, MD Princess Margaret Cancer Centre
PRS Account University Health Network, Toronto
Verification Date September 2019