Testing blood samples for esophageal cancer treatment
Personalized Multimodal Treatment for Resectable Esophageal Cancer by Detecting Minimal Residual Disease Using Circulating Tumor DNA: a Multicentric Prospective Study
This study is testing if blood tests can help track the progress of esophageal cancer treatment in patients who have had surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 248 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | chemotherapy, radiation, immunotherapy |
| Locations | 4 sites (Antwerp and 3 other locations) |
| Trial ID | NCT05704530 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of liquid biopsies in monitoring minimal residual disease (MRD) in patients with resectable esophageal cancer. It involves both retrospective and prospective collection of blood samples at various stages of treatment, including before and after surgery, and during adjuvant therapies. Patients will be grouped based on their treatment scenarios, allowing for tailored analysis of circulating tumor DNA (ctDNA) throughout their treatment journey. The study seeks to enhance understanding of disease progression and treatment response through non-invasive testing.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a new diagnosis of resectable esophageal cancer, specifically squamous cell carcinoma or adenocarcinoma.
Not a fit: Patients with metastatic disease or other active malignancies, as well as those who have previously undergone chemoradiation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved monitoring and management of esophageal cancer, potentially enhancing patient outcomes.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for cancer monitoring, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Antwerp and 3 other locations
- Uza — Antwerp, Belgium (Not_yet_recruiting)
- UZ Gent — Ghent, Belgium (Not_yet_recruiting)
- UZLeuven — Leuven, Belgium (Recruiting)
- AZ Delta — Roeselare, Belgium (Recruiting)
Study contacts
- Principal investigator: Jeroen Dekervel, MD — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Jeroen Dekervel, MD
- Email: jeroen.dekervel@uzleuven.be
- Phone: 016344225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.