Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer

Recruiting

• Conditions: Esophageal Cancer; Gastric Cancer
• Interventions: Diagnostic Test: Circulating tumor DNA

• Registration Number: NCT04576858
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

This is a prospective cohort study designed to evaluate the treatment effect as well as predictive and prognostic factors with special emphasis on the clinical utility of ctDNA in plasma in patients with gastroesophageal cancer. Patients with gastroesophageal cancer are included in 5 separate cohorts scheduled for

* Surgical resection + perioperative chemotherapy (cohort 1)

* Neoadjuvant chemoradiotherapy followed by surgical resection (cohort 2)

* Definitive chemoradiotherapy with curative intent (cohort 3)

* Systemic therapy with the intent to prolong survival (cohort 4)

* Palliative treatment without the use of chemotherapy (cohort 5)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-23
• Study Start: 2020-02-03
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-30
• Last Update Submitted: 2020-09-30
• Study First Posted: 2020-10-06
• Last Update Posted: 2020-10-06
• Primary Completion: 2025-02
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1950

Inclusion Criteria

Gastroesophageal cancer Age 18 years or older Able to understand and sign written informed consent

Exclusion Criteria

Patients not providing informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 4: Chemotherapy with the aim to prolong life expectancy	Circulating tumor DNA	-
Cohort 1: Surgical resection + perioperative chemotherapy	Circulating tumor DNA	-
Cohort 2: Neoadjuvant chemoradiotherapy followed by surgery	Circulating tumor DNA	-
Cohort 3: Definitive chemoradiotherapy	Circulating tumor DNA	-

Primary Outcome Measures

Name	Time	Method
Time to recurrence	1 year

Secondary Outcome Measures

Name	Time	Method
Time to progression	1 year
Overall survival	5 year
Response rate RECIST 1.1	through study completion, an average of 1 year
Response duration RECIST 1.1	through study completion, an average of 1 year

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark