Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541080
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Collection of Liquid Biopsy Samples of Neuroendocrine Neoplasms NEN Patients - Collection of NET CollectNET 20 a Study by the BE-FORCE Consortium
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Collection of Liquid Biopsy Samples of Patients With Neuroendocrine Neoplasms - CollectNET 20 a Study by the BE-FORCE Consortium
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BE-FORCE
Brief Summary:
The CollectNET 20 by BE-FORCE is a prospective multicentric interventional study in which liquid biopsies will be collected from neuroendocrine neoplasms NEN patients to create an extensive biobank that will be used for current and future circulating cell-free DNA ccfDNA analyses Two sampling groups will be created the Regular Sampling Group and the Intensive Sampling Group Upon participation up to four additional blood tubes max total of 325mL will be collected at each timepoint as specified below These include 3 Streck Cell-Free DNA tubes 10 mL each which will be used for the extraction of ccfDNA and 1 PreAnalytiX PAXgene Blood RNA tube 25 mL All NEN patients in one of the participating hospitals who have measurable tumor burden on imaging will be asked to participate in our study and will be included in the Regular Sampling Group If additionally the patient is i diagnosed with a histologically confirmed NEN of World Health Organisation WHO 2019 grade 1-3 neuroendocrine tumor NET or neuroendocrine carcinoma NEC from pancreatic colorectal or small intestinal origin and ii is starting any kind of 1st line systemic treatment eg somatostatin analogues targeted therapy chemotherapy etc they will be followed up more intensively as per the Intensive Sampling Group If during follow-up in this Intensive Sampling Group patients have disease progression or have completed follow-up for 3 years in this group their follow-up will switch back to the Regular Sampling Group for the remainder of the study Ultimately the samples collected in the Intensive Sampling Group will be used to achieve the second and third objective of our current project These are to validate novel ccfDNA analyzing techniques IMPRESS and GIPXplore for assessment of the presence and quantification of circular tumor DNA ctDNA in liquid biopsies and to monitor tumor fraction ie ctDNA quantities over time in sequential plasma samples from NEN patients using ccfDNA assays and correlating this with time to progression according to RECIST 11 criteria to explore the predictive efficacy of ccfDNA analysis and thereby evaluate its biomarker potential for patient follow-up While samples from the Regular Sampling Group and the PAXgene tubes will be biobanked for future projects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None