Clinical trial NCT06367751: Implementation of Liquid Biopsies During Routine Clinical Care in Patients With Advanced Malignancies (LIQPLAT)
Official title: Implementation of Liquid Biopsies During Routine Clinical Care in Patients With Advanced Malignancies (LIQPLAT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Solid Tumor
Keywords: ctDNA
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Research Center for Clinical Neuroimmunology and Neuroscience Basel
First posted: 2024-04-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.

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.

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

Primary outcomes:
measure: Number and proportion of patients in whom ctDNA was detectable before starting medical anticancer treatment
timeFrame: 1 time assessment at baseline
measure: Patients in whom actionable alterations were identified in ctDNA analysis
timeFrame: baseline, between month 2 and 3, between month 5 and 6, clinical event
measure: Turn-around time of ctDNA analysis
timeFrame: baseline, between month 2 and 3, between month 5 and 6, clinical event
measure: ctDNA kinetics
timeFrame: up to 24 months
Secondary outcomes:
measure: Number of ctDNA testing results that were successfully made available to the molecular tumor board
timeFrame: up to 24 months
measure: Number of patients being positive for ctDNA and suspicious Clonal Hematopoiesis of Indeterminate Potential
timeFrame: up to 24 months
measure: Quality of life and physical function
timeFrame: month 3, month 6, month 12
measure: Overall survival
timeFrame: up to 24 months
measure: Survival rate 6 months
timeFrame: Month 6
measure: Survival rate 12 months
timeFrame: Month 12
measure: Time to next treatment line
timeFrame: up to 24 months
measure: Unplanned hospital admissions and emergency room visits
timeFrame: up to 24 months
measure: Progression free survival
timeFrame: up to 24 months
measure: Number of ctDNA analyses with a valid result
timeFrame: up to 24 months
Other outcomes:
measure: Patients being referred and recruited to a different interventional clinical trial
timeFrame: up to 24 months
measure: Tissue biopsies per patient
timeFrame: up to 24 months
measure: Imaging per patient
timeFrame: up to 24 months
measure: Blood products per patient
timeFrame: up to 24 months
measure: Cumulative doses of cancer drug treatments administered
timeFrame: up to 24 months
Locations:
city: Basel
country: Switzerland
facility: Department of Medical Oncology, University Hospital Basel
Study officials:
affiliation: USB
name: Benjamin Kasenda, PD. Dr. med et Dr. phil.
role: PRINCIPAL_INVESTIGATOR
References: