Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer (CURE)

Rigshospitalet

Status: Enrolling

Conditions: Gastric Cancer; Esophageal Cancer

Treatments: Diagnostic Test: Circulating tumor DNA

Study type: Observational

Funder types: Other

Identifiers

NCT04576858

CURE

Details and patient eligibility

About

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)

Enrollment: 1,950 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Patients not providing informed consent

Trial design

1,950 participants in 5 patient groups

Cohort 1: Surgical resection + perioperative chemotherapy

Treatment:

Diagnostic Test: Circulating tumor DNA

Cohort 2: Neoadjuvant chemoradiotherapy followed by surgery

Treatment:

Diagnostic Test: Circulating tumor DNA

Cohort 3: Definitive chemoradiotherapy

Treatment:

Diagnostic Test: Circulating tumor DNA

Cohort 4: Chemotherapy with the aim to prolong life expectancy

Treatment:

Diagnostic Test: Circulating tumor DNA

Cohort 5: Non-chemotherapeutic palliation

Description:

E.g. Palliative radiotherapy