RecruitingNot ApplicableNCT05704530

Liquid Biopsies in Esophageal Cancer

Personalized Multimodal Treatment for Resectable Esophageal Cancer by Detecting Minimal Residual Disease Using Circulating Tumor DNA: a Multicentric Prospective Study

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

248 participants

Start Date

Mar 29, 2023

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer

Summary

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

Min Age: 18 Years

Inclusion Criteria5

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
Able to provide informed consent (ICF) according to Good Clinical Practice and national/European regulations

Exclusion Criteria5

(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)
Treatment plan after MDT: neoadjuvant chemotherapy with no radiation or chemoradiation with definitive intent (surgery is not planned)

Interventions

OTHERBlood sample

Retrospective 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.