Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04750109
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2021-02-10
Brief Title:
Carcinoma of Unknown Primary CUP a Comparison Across Tissue and Liquid Biomarkers
Sponsor:
The Christie NHS Foundation Trust
Organization:
The Christie NHS Foundation Trust
Study Overview
Official Title:
Carcinoma of Unknown Primary CUP a Comparison Across Tissue and Liquid
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
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:
CUP-COMP
Brief Summary:
Patients with Carcinoma of Unknown Primary CUP have widespread cancer at diagnosis however the specific site of origin cannot be found despite significant testing making it difficult to treat CUP has a poor prognosis it is the 6th most common cause of cancer death in the UK
To date there have been limited studies investigating molecular genomics in CUP patients resulting in limited evidence to evaluate whether genomic profiling has added value over and above the standard diagnostics provided in the NHS
As a result our project will aim to
Assess genomic sequencing both in tissue and blood for the diagnosis and treatment guidance in CUP patients including a comparison of the effectiveness of tissue and blood based biomarkers
Collect evidence to further develop technology that predicts an individuals response to a treatment
Develop innovative systems of clinical data capture in patients with CUP
Investigate novel biomarkers to determine the primary tumour location Approximately 120-140 CUP patients will be recruited across 7 UK NHS sites Tumour samples will be collected from patients undergoing a standard of care procedure OR medically fit patients with accessible tumour Archival tumour may also be obtained Some samples will be stored for future translational research
Sequencing results alongside clinical data will be discussed by a multi-disciplinary CUP Molecular Tumour Board They will provide oversight on the nature clinical significance and relevance of the results They will inform the local CUP team of any actionable genetic changes which could potentially direct selection of a targeted therapy trial for that patient Sequential blood samples will be collected to investigate genetic characteristics that may be able to predict response to therapy
The aggregated anonymised data will be made publicly available following completion of this trial
To date there have been limited studies investigating molecular genomics in CUP patients resulting in limited evidence to evaluate whether genomic profiling has added value over and above the standard diagnostics provided in the NHS
As a result our project will aim to
Assess genomic sequencing both in tissue and blood for the diagnosis and treatment guidance in CUP patients including a comparison of the effectiveness of tissue and blood based biomarkers
Collect evidence to further develop technology that predicts an individuals response to a treatment
Develop innovative systems of clinical data capture in patients with CUP
Investigate novel biomarkers to determine the primary tumour location Approximately 120-140 CUP patients will be recruited across 7 UK NHS sites Tumour samples will be collected from patients undergoing a standard of care procedure OR medically fit patients with accessible tumour Archival tumour may also be obtained Some samples will be stored for future translational research
Sequencing results alongside clinical data will be discussed by a multi-disciplinary CUP Molecular Tumour Board They will provide oversight on the nature clinical significance and relevance of the results They will inform the local CUP team of any actionable genetic changes which could potentially direct selection of a targeted therapy trial for that patient Sequential blood samples will be collected to investigate genetic characteristics that may be able to predict response to therapy
The aggregated anonymised data will be made publicly available following completion of this trial
Detailed Description:
None
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