Liquid Biopsies in Esophageal Cancer
ConditionEsophageal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
Purpose of this study is to determine the value of liquid biopsies, e.g. testing of minimal residual disease (MRD) by using liquid biopsies to measure circulating tumour DNA (ctDNA) at diagnosis and during the multimodal and multidisciplinary curative-intent treatment of resectable esophageal cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, age > 18 years
New diagnosis of esophageal cancer, pathologically confirmed squamous cell carcinoma (ESCC) or adenocarcinoma (EAC)
Clinically staged - cT1-4 N0-2 M0 (local or locally advanced, resectable)
Eligible for multidisciplinary treatment as assessed by MDT
Disqualifiers
(Oligo)metastatic disease
Histologically or cytologically confirmed diagnosis other than squamous cell carcinoma or adenocarcinoma (eg. neuroendocrine carcinoma, lymphoma…)
Other active malignancies
Previous exposure to chemoradiation (prior to MDT)
Trial design
Design model
Parallel
Treatments tested in this trial
Blood sample
Other interventionRetrospective collection of leftover tissue from standard of care biopsies or resection specimens and prospective collection of additional blood samples for study-specific analyses at specific timepoints, at the same time as routine labs are foreseen. No additional venipunctures are expected.
Treatment groups
248 Participants
are divided into 3 treatment groupsGroup A: 1. primary resection then follow-upOther 1 intervention
Group B: 2. chemoradiation followed by resection and follow-upOther 1 intervention
Group C: 3. chemoradiation followed by resection followed by adjuvant immunotherapyOther 1 intervention
Trial outcomes
Primary outcomes
1
To assess the potency of ctDNA MRD variant allele frequency to improve clinical staging at diagnosis of esophageal cancer.
To assess whether ctDNA concentration can significantly contribute to preoperative staging in esophageal cancer, to define a significant cut-off value of ctDNA concentration with optimal sensitivity and specificity and validate the results.
Time frame
12 months2
To correlate the presence of minimal residual disease after resection as assessed by ctDNA with disease recurrence.
To compare the two groups ctDNA positive and negative post-resection in terms of progression-free survival and overall survival (Kaplan-Meier time-to-event) and evaluate the performance of ctDNA to predict disease recurrence (Cox proportional hazards model).
Time frame
12 months3
To observe the ctDNA MRD dynamics during adjuvant immunotherapy .
To describe the dynamics of ctDNA concentration (proportion of clearance of positive ctDNA) during standard of care adjuvant immunotherapy.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Kom Op Tegen Kanker
Collaborator
Source ClinicalTrials.gov