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Clinical Trials/NCT04576858
NCT04576858
Recruiting
Not Applicable

Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer

Rigshospitalet, Denmark1 site in 1 country1,950 target enrollmentFebruary 3, 2020
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ConditionsEsophageal CancerGastric Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Cancer
Sponsor
Rigshospitalet, Denmark
Enrollment
1950
Locations
1
Primary Endpoint
Time to recurrence
Status
Recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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)
Registry
clinicaltrials.gov
Start Date
February 3, 2020
End Date
July 2025
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Morten Mau-Sørensen

Chief Physician, MD, PhD

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • •Patients not providing informed consent

Outcomes

Primary Outcomes

Time to recurrence

Time Frame: 1 year

Secondary Outcomes

  • 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)

Study Sites (1)

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