Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367751
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-04-11
Brief Title:
Implementation of Liquid Biopsies During Routine Clinical Care in Patients With Advanced Malignancies LIQPLAT
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Implementation of Liquid Biopsies During Routine Clinical Care in Patients With Advanced Malignancies LIQPLAT
Status:
RECRUITING
Status Verified Date:
2024-06
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:
LIQPLAT
Brief Summary:
The goal of this study is to assess the implementation and feasibility of ctDNA measurements from blood samples obtained during routine clinical care of cancer patients in the University Hospital Basel
Researchers will compare clinical and patient reported outcomes from the LIQPLAT study with patients who did not receive ctDNA measurements external comparator from registry AO_2023-00091
Blood samples will be drawn from the patients as part of routine care and ctDNA measurements will be performed on these samples
Researchers will compare clinical and patient reported outcomes from the LIQPLAT study with patients who did not receive ctDNA measurements external comparator from registry AO_2023-00091
Blood samples will be drawn from the patients as part of routine care and ctDNA measurements will be performed on these samples
Detailed Description:
Liquid biopsies in particular the analysis of circulating tumor DNA ctDNA have emerged as a promising tool for detecting and monitoring cancer Measuring ctDNA in patients with solid malignancies may help to identify targetable alterations measure disease burden identify early mutations of resistance tailor and deescalate cancer treatment and predict patient prognosis Although the adoption and application of ctDNA measurements for patients with solid tumors in routine clinical care is increasing evidence supporting the integration of ctDNA into current practice is limited especially for patients with advanced cancers
This is a trial using routinely collected health care data from an ongoing registry AO_2023-00091 in cancer patients with advanced solid malignancies receiving first line systemic anticancer treatment for advanced disease
This trial will assess the feasibility and implementation of routine measurement of ctDNA and its association with clinical outcomes including quality of life and survival All patients will receive routine diagnostics treatment and follow-up All patients with a new cancer diagnosis will be assessed for eligibility based on the routinely collected information available in the registry We will then randomly decide which eligible patients are invited to participate in the trial If patients accept the invitation and intend to get a measurement of ctDNA they have to provide written informed consent
Results from ctDNA analyses will be discussed at the molecular tumor board an established regular interdisciplinary meeting at the University Hospital Basel part of routine care to discuss patients with complex findings from tumor sequencing analyses Treatment changes occurring during the trial duration will be at the discretion of treating physician and according to patients preference as is routine standard of care
This is a trial using routinely collected health care data from an ongoing registry AO_2023-00091 in cancer patients with advanced solid malignancies receiving first line systemic anticancer treatment for advanced disease
This trial will assess the feasibility and implementation of routine measurement of ctDNA and its association with clinical outcomes including quality of life and survival All patients will receive routine diagnostics treatment and follow-up All patients with a new cancer diagnosis will be assessed for eligibility based on the routinely collected information available in the registry We will then randomly decide which eligible patients are invited to participate in the trial If patients accept the invitation and intend to get a measurement of ctDNA they have to provide written informed consent
Results from ctDNA analyses will be discussed at the molecular tumor board an established regular interdisciplinary meeting at the University Hospital Basel part of routine care to discuss patients with complex findings from tumor sequencing analyses Treatment changes occurring during the trial duration will be at the discretion of treating physician and according to patients preference as is routine standard of care
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