Liquid Biopsies in Esophageal Cancer

NCT05704530 | Recruiting

• 1 other identifier: S67328
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  12 months

• 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).

  12 months

• 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.

  12 months

Study Arms (3)

1. primary resection then follow-up

OTHER

Scenario 1: primary resection then follow-up - Study-specific liquid biopsies will be collected in 98 patients, at the time of routine labs. Samples will be acquired before resection, at 6-8 weeks, 6 and 12 months after resection.

Other: Blood sample

2. chemoradiation followed by resection and follow-up

OTHER

Scenario 2: chemoradiation followed by resection and follow-up - Study-specific liquid biopsies will be collected in 50 patients. Samples will be acquired before the start of chemoradiation, before surgery, 6-8 weeks, 6 and 12 months after surgery. A subgroup of patients will undertake adjuvant immunotherapy and will constitute Group 3. Timing of sampling will be adjusted accordingly as per study flowcharts.

Other: Blood sample

3. chemoradiation followed by resection followed by adjuvant immunotherapy

OTHER

chemoradiation followed by resection followed by adjuvant immunotherapy - Study-specific liquid biopsies will be collected in 100 patients. Samples will be acquired before the start of chemoradiation, before surgery, 6-8 weeks after surgery and during adjuvant immunotherapy every 3 months including a sample at the end of treatment.

Other: Blood sample

Interventions

Blood sample OTHER

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.

1. primary resection then follow-up; 2. chemoradiation followed by resection and follow-up; 3. chemoradiation followed by resection followed by adjuvant immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• (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)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Kom Op Tegen Kanker: collaborator

Study Sites (4)

UZA

Antwerp, Belgium

NOT YET RECRUITING

UZ Gent

Ghent, Belgium

NOT YET RECRUITING

UZLeuven

Leuven, Belgium

RECRUITING

AZ Delta

Roeselare, Belgium

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jeroen Dekervel, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeroen Dekervel, MD

CONTACT

016344225; jeroen.dekervel@uzleuven.be

Filip Van Herpe, MD

CONTACT

016344225; filip.vanherpe@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three distinct patient groups are defined, depending on the therapeutic scenario patients undertake. Patient management is standard of care. No investigational medicinal product (IMP) is involved. Trial is considered low interventional due to addition of extra blood samples, otherwise would be observational.

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: January 30, 2023
• Study Start: March 29, 2023
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4)