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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-02

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ctDNA measurement

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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ctDNA measurement

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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