RECRUITINGINTERVENTIONAL

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

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.

Who May Be Eligible (Plain English)

Key inclusion criteria are: 1. Male or female, age \> 18 years 2. New diagnosis of esophageal cancer, pathologically confirmed squamous cell carcinoma (ESCC) or adenocarcinoma (EAC) 3. Clinically staged - cT1-4 N0-2 M0 (local or locally advanced, resectable) 4. Eligible for multidisciplinary treatment as assessed by MDT 5. Able to provide willing to sign a consent form (ICF) according to Good Clinical Practice and national/European regulations Key exclusion criteria are: 1. (Oligo)metastatic disease 2. diagnosed by tissue sample (biopsy-confirmed) diagnosis other than squamous cell carcinoma or adenocarcinoma (eg. neuroendocrine carcinoma, lymphoma…) 3. Other active malignancies 4. Previous exposure to chemoradiation (prior to MDT) 5. Treatment plan after MDT: neoadjuvant chemotherapy with no radiation or chemoradiation with definitive intent (surgery is not planned) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Key inclusion criteria are: 1. Male or female, age \> 18 years 2. New diagnosis of esophageal cancer, pathologically confirmed squamous cell carcinoma (ESCC) or adenocarcinoma (EAC) 3. Clinically staged - cT1-4 N0-2 M0 (local or locally advanced, resectable) 4. Eligible for multidisciplinary treatment as assessed by MDT 5. Able to provide informed consent (ICF) according to Good Clinical Practice and national/European regulations Key exclusion criteria are: 1. (Oligo)metastatic disease 2. Histologically or cytologically confirmed diagnosis other than squamous cell carcinoma or adenocarcinoma (eg. neuroendocrine carcinoma, lymphoma…) 3. Other active malignancies 4. Previous exposure to chemoradiation (prior to MDT) 5. Treatment plan after MDT: neoadjuvant chemotherapy with no radiation or chemoradiation with definitive intent (surgery is not planned)

Treatments Being Tested

OTHER

Blood 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.

Locations (4)

UZA

Antwerp, Belgium

UZ Gent

Ghent, Belgium

UZLeuven

Leuven, Belgium

AZ Delta

Roeselare, Belgium