Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05763511
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2022-07-04
Brief Title:
Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
This project investigates circulating tumor DNA ctDNA in patients with suspected ovarian malignancy
We hypothesize that measurement of ctDNA in women with suspected ovarian cancer can improve the diagnostic efficiency for preoperative differentiation between benign and malignant masses
Specifically we hope to determine the diagnostic efficiency of ctDNA alone and ctDNA in combination with imaging modalities ultrasonography MRI PET-CT and CA 125 for preoperative differentiation between benign and malignant adnexal masses Based on this we hope to develop an improved diagnostic algorithm
The mutational profile and relation to tumour type stage treatment response and prognosis will be explored
Analyses of blood and tissue samples will be used to examine the disease development and biology
Blood samples tumour tissue and data on imaging modalities as well as CA 125 will be collected prospectively in consecutive women referred to Aarhus University Hospital
We hypothesize that measurement of ctDNA in women with suspected ovarian cancer can improve the diagnostic efficiency for preoperative differentiation between benign and malignant masses
Specifically we hope to determine the diagnostic efficiency of ctDNA alone and ctDNA in combination with imaging modalities ultrasonography MRI PET-CT and CA 125 for preoperative differentiation between benign and malignant adnexal masses Based on this we hope to develop an improved diagnostic algorithm
The mutational profile and relation to tumour type stage treatment response and prognosis will be explored
Analyses of blood and tissue samples will be used to examine the disease development and biology
Blood samples tumour tissue and data on imaging modalities as well as CA 125 will be collected prospectively in consecutive women referred to Aarhus University Hospital
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