Implementation of Liquid Biopsies During Routine Clinical Care in Patients With Advanced Malignancies (LIQPLAT) (LIQPLAT)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Diagnostic test: ctDNA measurement

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.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Department of Medical Oncology, University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Comparator; Patients included in the ongoing registry AO_2023-00091. Patients will have ctDNA measurements being performed on blood samples collected as part of clinical routine.	Diagnostic test: ctDNA measurement; Blood samples are collected as part of standard of care and ctDNA measurements will be performed on these samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and proportion of patients in whom ctDNA was detectable before starting medical anticancer treatment	Number and proportion of patients in whom ctDNA was detectable before starting medical anticancer treatment. Calculated as the number of patients with detectable ctDNA over the total number of patients included, expressed as a percentage.	1 time assessment at baseline
Patients in whom actionable alterations were identified in ctDNA analysis	Patients in whom actionable alterations were identified in ctDNA analysis. Calculated as the number of patients with actionable alterations over the total number of patients included, expressed as a percentage. Clinical event is defined as suspicious or confirmed clinical or radiological disease progression or treatment discontinuation for any reason.	baseline, between month 2 and 3, between month 5 and 6, clinical event
Turn-around time of ctDNA analysis	Time from ctDNA request until issuing the first report. Expressed as hours. Clinical event is defined as suspicious or confirmed clinical or radiological disease progression or treatment discontinuation for any reason.	baseline, between month 2 and 3, between month 5 and 6, clinical event
ctDNA kinetics	Change in allelic frequency over time including relative changes from baseline.	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of ctDNA testing results that were successfully made available to the molecular tumor board	Number of ctDNA testing results that were successfully made available to the molecular tumor board.	up to 24 months
Number of patients being positive for ctDNA and suspicious Clonal Hematopoiesis of Indeterminate Potential	Number of patients being positive for ctDNA and suspicious Clonal Hematopoiesis of Indeterminate Potential	up to 24 months
Overall survival	Overall survival.	up to 24 months
Survival rate 6 months	Survival rate 6 months.	Month 6
Survival rate 12 months	Survival rate 12 months.	Month 12
Time to next treatment line	Time to next treatment line, expressed in days.	up to 24 months
Unplanned hospital admissions and emergency room visits	Number and proportion of unplanned hospital admissions and emergency room visits.	up to 24 months
Progression free survival	Progression free survival as determined by routine imaging (e.g. CT scan, MRI), tumor marker (e.g. PSA). Defined as time from date of informed consent until disease progression or death, whatever occurs first.	up to 24 months
Number of ctDNA analyses with a valid result	Number of ctDNA analyses with a valid result - that is all ctDNA analyses conducted without any observed technical errors.	up to 24 months
Quality of life and physical function	Global quality of life and physical function as measured by EORTC QLQ C30 and C15 (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire). Calculation of the scores follows the validated formulas as issued by the EORTC. Scores range from 0% to 100% for all domains with higher values representing better outcome.	month 3, month 6, month 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients being referred and recruited to a different interventional clinical trial	Number and proportion of patients being referred and recruited to a different interventional clinical trial.	up to 24 months
Tissue biopsies per patient	Number of (solid) tissue biopsies per patient and proportion of patients receiving a biopsy.	up to 24 months
Imaging per patient	Number of imaging per patient (CT, PET/CT or MRI).	up to 24 months
Blood products per patient	Number of blood products per patient.	up to 24 months
Cumulative doses of cancer drug treatments administered	Cumulative doses of cancer drug treatments administered.	up to 24 months

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Research Center for Clinical Neuroimmunology and Neuroscience Basel
• Investigators: Principal Investigator: Benjamin Kasenda, PD. Dr. med et Dr. phil., USB

Publications and helpful links

General Publications

• Schwenke JM, Schmitt AM, McLennan S, Janiaud P, Laubli H, Binder M, Alborelli I, Matter MS, Hinke J, Widmer CC, Hemkens LG, Kasenda B, Briel M. Mixed-methods process evaluation of ctDNA use to guide decision-making in patients with advanced solid cancers: study protocol for a substudy of the LIQPLAT trial. BMJ Open. 2025 Oct 28;15(10):e100537. doi: 10.1136/bmjopen-2025-100537.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: ctDNA
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2024-00358; th23Kasenda

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared upon reasonable request following SPHN (https://sphn.ch/) guidelines for data sharing.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No