Ignite Creation Date:
2024-05-06 @ 4:25 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04983628
Status:
UNKNOWN
Last Update Posted:
2023-03-01
First Post:
2021-02-16
Brief Title:
Molecular Profiling in Prostate Cancer
Sponsor:
Hellenic Cooperative Oncology Group
Organization:
Hellenic Cooperative Oncology Group
Study Overview
Official Title:
Prognostic and Predictive Value of Tumor Molecular Alterations in Patients With Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProProstate
Brief Summary:
We aim to employ targeted DNA NGS to evaluate the prevalence of germline and somatic mutations in cancer predisposing genes such as BRCA1 and BRCA2 and other HR and DDR genes including also a few additional clinically relevant genes in patients with metastatic locally advanced or high-grade prostate cancer In addition we will investigate the prognostic role of these mutations as well as their association with various clinicopathological parameters This will be the first study investigating the prevalence of germline and somatic pathogenic mutations in Greek patients with prostate cancer
Detailed Description:
This study will include formalin-fixed paraffin-embedded tumor tissue FFPE from 250 patients with metastatic recurrent locally advanced or intermediate or high risk Gleason 7 operable prostate cancer FFPE tumor blocks alongside peripheral blood will be retrieved for all patients from Pathology Laboratories Available FFPE blocks will be subjected to histological review by an experienced pathologist to evaluate HE sections for confirmation of diagnosis histologic type grade and tumor cell content TCC as well as mark tumor dense areas for manual macro-dissection prior to DNA extraction in order to enrich samples for tumor DNA Clinicopathologic characteristics of patients with prostate cancer will be retrieved from their respective medical records Diagnosis will be confirmed through pathology reports which will also provide information about Gleason Score and histological subtype
In all instances the collection of patient information will be in compliance with the regulations of the Bioethics committees of participating Hospitals The study will be conducted in accordance with the principles of the Helsinki Declaration of Human Rights
Following manual macro-dissection FFPE tumor tissue material will be processed for DNA extraction according to standard procedures with the QIAamp DNA Mini Kit Qiagen GmbH Hilden Germany
Sequencing will be performed at the Laboratory of Molecular Oncology using an Ion Torrent Proton Sequencer Life TechnologiesIon Torrent For the purpose of targeted NGS genotyping of tumor and available matched germline DNA samples we designed a custom Ampliseq panel to target coding relevant regions of genes involved in homologous recombination HR along with several others
Data retrieval and base calling will be performed on the Torrent Server v5808 Consequently we will then employ appropriate Ion Reporter Workflows version 510 to automatically annotate single nucleotide variants SNVs multiple nucleotide variants MNVs small insertions deletions INDELs and copy number variations CNVs
In all instances the collection of patient information will be in compliance with the regulations of the Bioethics committees of participating Hospitals The study will be conducted in accordance with the principles of the Helsinki Declaration of Human Rights
Following manual macro-dissection FFPE tumor tissue material will be processed for DNA extraction according to standard procedures with the QIAamp DNA Mini Kit Qiagen GmbH Hilden Germany
Sequencing will be performed at the Laboratory of Molecular Oncology using an Ion Torrent Proton Sequencer Life TechnologiesIon Torrent For the purpose of targeted NGS genotyping of tumor and available matched germline DNA samples we designed a custom Ampliseq panel to target coding relevant regions of genes involved in homologous recombination HR along with several others
Data retrieval and base calling will be performed on the Torrent Server v5808 Consequently we will then employ appropriate Ion Reporter Workflows version 510 to automatically annotate single nucleotide variants SNVs multiple nucleotide variants MNVs small insertions deletions INDELs and copy number variations CNVs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None