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Trial record 2 of 2787 for:    Neoplasms, Germ Cell and Embryonal | Neuroendocrine Tumors

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

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.

Condition or disease
Neuroendocrine Tumors Pancreatic Neuroendocrine Tumors

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).

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Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors
Study Start Date : October 2013
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020


Group/Cohort
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.



Primary Outcome Measures :
  1. To prospectively collect tumor tissue and blood sample from patients with carcinoid tumors and islet cell tumors. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. To evaluate gene alterations differences between carcinoid tumors and islet cell tumors. [ Time Frame: 3 years ]
  2. To correlate genomic findings with treatment and clinical outcome. [ Time Frame: 3 years ]
  3. To compare acquired data with existent available databases of whole genome or exome of neuroendocrine tumors [ Time Frame: 3 years ]
  4. 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 ]

Biospecimen Retention:   Samples With DNA
Fresh tumor tissue, 3 tubes of whole blood, archival tumor tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02586844


Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
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Principal Investigator: Lillian Siu, MD Princess Margaret Cancer Centre

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02586844     History of Changes
Other Study ID Numbers: NET-SEQ
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Keywords provided by University Health Network, Toronto:
NET
PanNET
Molecular profiling
Transcriptome sequencing
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue