Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer
CURE
1 other identifier
observational
1,950
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2020
CompletedStudy Start
First participant enrolled
February 3, 2020
CompletedFirst Posted
Study publicly available on registry
October 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedOctober 6, 2020
September 1, 2020
5 years
January 23, 2020
September 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to recurrence
1 year
Secondary Outcomes (4)
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 Arms (5)
Cohort 1: Surgical resection + perioperative chemotherapy
Cohort 2: Neoadjuvant chemoradiotherapy followed by surgery
Cohort 3: Definitive chemoradiotherapy
Cohort 4: Chemotherapy with the aim to prolong life expectancy
Cohort 5: Non-chemotherapeutic palliation
E.g. Palliative radiotherapy
Interventions
Measurement of circulating tumor DNA from plasma over a period of 2 years.
Eligibility Criteria
The study population includes patients with gastroesophageal cancer in five prospective cohorts. Neither WGS/WES on primary tumor nor serial blood samples for ctDNA are mandatory for inclusion in the study. However, it is highly encouraged to perform WGS/WES of the primary tumor. A retrospective cohort will be open for inclusion to facilitate initial hypothesis testing to be validated in the prospective cohorts
You may qualify if:
- Gastroesophageal cancer Age 18 years or older Able to understand and sign written informed consent
You may not qualify if:
- Patients not providing informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet
Copenhagen, 2100, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician, MD, PhD
Study Record Dates
First Submitted
January 23, 2020
First Posted
October 6, 2020
Study Start
February 3, 2020
Primary Completion
February 1, 2025
Study Completion
July 1, 2025
Last Updated
October 6, 2020
Record last verified: 2020-09