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

NCT06367751 | Active Not Recruiting

• 1 other identifier: 2024-00358; th23Kasenda
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Keywords

ctDNA

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• 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

  up to 24 months

• Quality of life and physical function

  month 3, month 6, month 12

• Overall survival

  up to 24 months

• Survival rate 6 months

  Month 6

Other Outcomes (5)

• Patients being referred and recruited to a different interventional clinical trial

  up to 24 months

• Tissue biopsies per patient

  up to 24 months

• Imaging per patient

  up to 24 months

Study Arms (1)

Active Comparator

EXPERIMENTAL

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

Interventions

ctDNA measurement DIAGNOSTIC_TEST

Blood samples are collected as part of standard of care and ctDNA measurements will be performed on these samples.

Active Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• ● Patients with primary brain tumors

Sponsors & Collaborators

• Research Center for Clinical Neuroimmunology and Neuroscience Basel: collaborator
• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Medical Oncology, University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 41151945 DERIVED

Study Officials

• Benjamin Kasenda, PD. Dr. med et Dr. phil.

  USB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: May 2, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CH (1)