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Trial Title:
Implementation of Liquid Biopsies During Routine Clinical Care in Patients With Advanced Malignancies (LIQPLAT)
NCT ID:
NCT06367751
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
ctDNA
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
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 anti-cancer treatment for advanced disease. 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. The study comprises an external comparator
arm with 75 (anticipated) cancer patients, and an active comparator arm with 150
(anticipated) cancer patients.
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
ctDNA measurement
Description:
Blood samples are collected as part of standard of care and ctDNA measurements will be
performed on these samples.
Arm group label:
Active Comparator
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.
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 patient's preference as is routine standard of care.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with a proven solid malignant disease, i.e. with solid malignant tumors
where no primary surgical resection is planned OR solid malignant tumors that are
locally advanced and inoperable OR solid tumors that are metastatic
- No prior treatment for advanced/metastatic disease
- Indication for medical anti-cancer treatment (including combined chemoradiotherapy)
as judged by the treating physician
- Patient age 18 years and older
- General research consent of the University Hospital Basel
Exclusion Criteria:
● Patients with primary brain tumors
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Medical Oncology, University Hospital Basel
Address:
City:
Basel
Zip:
4031
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Benjamin Kasenda, PD. Dr. med et Dr. phil.
Phone:
+41 61 265 50 75
Email:
Benjamin.Kasenda@usb.ch
Contact backup:
Last name:
Andreas Michael Schmitt, Dr.
Phone:
+41 61 265 50 75
Email:
AndreasMichael.Schmitt@usb.ch
Investigator:
Last name:
Benjamin Kasenda, PD. Dr. med et Dr. phil.
Email:
Principal Investigator
Investigator:
Last name:
Andreas Michael Schmitt, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Heinz Läubli, Prof. Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Mascha Binder, Prof. Dr.
Email:
Sub-Investigator
Start date:
May 2, 2024
Completion date:
October 2026
Lead sponsor:
Agency:
University Hospital, Basel, Switzerland
Agency class:
Other
Collaborator:
Agency:
Research Center for Clinical Neuroimmunology and Neuroscience Basel
Agency class:
Other
Source:
University Hospital, Basel, Switzerland
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06367751
