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

Advanced Solid Tumor Clinical Trial

— LIQPLAT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06367751
• Other study ID #: 2024-00358; th23Kasenda
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: October 2026

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Benjamin Kasenda, PD. Dr. med et Dr. phil.
• Phone: 0041 61 265 50 75
• Email: Benjamin.Kasenda[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Diagnostic Test:
• ctDNA measurement
Blood samples are collected as part of standard of care and ctDNA measurements will be performed on these samples.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Research Center for Clinical Neuroimmunology and Neuroscience Basel

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Tissue biopsies per patient	Number of (solid) tissue biopsies per patient and proportion of patients receiving a biopsy.	up to 24 months
Other	Imaging per patient	Number of imaging per patient (CT, PET/CT or MRI).	up to 24 months
Other	Blood products per patient	Number of blood products per patient.	up to 24 months
Other	Cumulative doses of cancer drug treatments administered	Cumulative doses of cancer drug treatments administered.	up to 24 months
Primary	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
Primary	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
Primary	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
Primary	ctDNA kinetics	Change in allelic frequency over time including relative changes from baseline.	up to 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall survival	Overall survival.	up to 24 months
Secondary	Survival rate 6 months	Survival rate 6 months.	Month 6
Secondary	Survival rate 12 months	Survival rate 12 months.	Month 12
Secondary	Time to next treatment line	Time to next treatment line, expressed in days.	up to 24 months
Secondary	Unplanned hospital admissions and emergency room visits	Number and proportion of unplanned hospital admissions and emergency room visits.	up to 24 months
Secondary	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
Secondary	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