Determining Minimal Residual Disease Using ctDNA Deep Sequencing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMasaryk Memorial Cancer Institute
About this trial
Preoperative neoadjuvant chemotherapy is the standard treatment for locally advanced gastrointestinal tumours. However, not all patients respond to preoperative treatment. Early identification of progression during neoadjuvant chemotherapy or diagnosis of early disease relapse during adjuvant treatment is essential to modify the treatment strategy. The aim of this project is to validate ctDNA as a biomarker of molecular relapse/progression of disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Consent to participate in the study
Patients with esophageal, gastric, or pancreatic cancer, stage 0-2
Patients with locally advanced, potentially operable disease treated with systemic perioperative chemotherapy or chemoradiotherapy
Patients with metastatic disease treated with first- to third-line palliative systemic therapy
Disqualifiers
not specified
Trial design
Design model
Parallel
Treatments tested in this trial
NGS sequencing of mutations selected based on sequencing of primary tumors
Diagnostic testSequencing of the primary tumor will be performed on a MiSeq instrument using the Accel-Amplicon panel, which covers the most common mutations. For deep sequencing of ctDNA, 2-3 genomic regions carrying mutations in the primary tumor will be selected for the patient. For these regions, sets of universal primers will be designed to amplify the mutations most commonly found in solid tumors (RAS, BRAF, TP53, EGFR, APC, etc.). Another set of universal primers will contain a sequence for indexing individual samples, enabling the parallel sequencing of up to 96 samples simultaneously. The sequencing library will be analyzed on a NextSeq 500 instrument, which allows for up to 400 million reads in a single sequencing run. The sequencing results will then be correlated with the clinical course of the disease.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: InterventionalExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity of targeted NGS assay for ctDNA mutation detection
Proportion of tumor-confirmed driver mutations detected in plasma cfDNA using the developed targeted NGS assay. Unit of Measure: Percentage (%)
Time frame
Through study completion, an average of 24 months.Secondary outcomes
1
Monitoring ctDNA levels
A secondary objective is to monitor ctDNA levels throughout the patient's treatment and to determine appropriate intervals for plasma collection after surgery and during adjuvant therapy.
Time frame
Through study completion, an average of 24 months.2
Variant allele frequency (VAF) of detected driver mutations in cfDNA
Quantitative assessment of tumor-specific mutations detected in cfDNA using targeted NGS sequencing. Unit of Measure: Variant allele frequency (%)
Time frame
Through study completion, an average of 24 months.Sponsors and contacts
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Source ClinicalTrials.gov