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

September 30, 2020 updated by: Morten Mau-Sørensen, Rigshospitalet, Denmark

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Morten Mau-Sørensen, MD, PhD
  • Phone Number: 0045 35450879
  • Email: mms@rh.regionh.dk

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Contact:
        • Principal Investigator:
          • Lene Baeksgaard
        • Principal Investigator:
          • Michael Achiam
        • Principal Investigator:
          • Rajendra S Garbyal
        • Principal Investigator:
          • Olga Oestrup
        • Sub-Investigator:
          • Mette Siemsen
        • Sub-Investigator:
          • Morten Thorsteinsson
        • Sub-Investigator:
          • Camilla Qvortrup
        • Sub-Investigator:
          • Jane P Hasselby
        • Sub-Investigator:
          • Lise B Ahlborn
        • Principal Investigator:
          • Morten Mau-Sørensen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1: Surgical resection + perioperative chemotherapy
Diagnostic test: Circulating tumor DNA
Measurement of circulating tumor DNA from plasma over a period of 2 years.
Cohort 2: Neoadjuvant chemoradiotherapy followed by surgery
Diagnostic test: Circulating tumor DNA
Measurement of circulating tumor DNA from plasma over a period of 2 years.
Cohort 3: Definitive chemoradiotherapy
Diagnostic test: Circulating tumor DNA
Measurement of circulating tumor DNA from plasma over a period of 2 years.
Cohort 4: Chemotherapy with the aim to prolong life expectancy
Diagnostic test: Circulating tumor DNA
Measurement of circulating tumor DNA from plasma over a period of 2 years.
Cohort 5: Non-chemotherapeutic palliation
E.g. Palliative radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to recurrence
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 year
5 year
Time to progression
Time Frame: 1 year
1 year
Response rate RECIST 1.1
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Response duration RECIST 1.1
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2020

Primary Completion (Anticipated)

February 1, 2025

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

September 30, 2020

First Posted (Actual)

October 6, 2020

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

September 30, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CURE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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