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Clinical Trials/NCT04576858
NCT04576858RecruitingNot Applicable

Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer

Rigshospitalet, Denmark1 site in 1 country1,950 target enrollmentStarted: February 3, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
1,950
Locations
1
Primary Endpoint
Time to recurrence
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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)

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Morten Mau-Sørensen

Chief Physician, MD, PhD

Rigshospitalet, Denmark

Study Sites (1)

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Clinical Utility of Circulating Tumor DNA... | Clinical Trial