Esophageal CancerCURENCT04576858
Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer
An observational study of Esophageal Cancer and Gastric Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer
- What is being tested?
- Circulating tumor DNA
- How many people
- 1,950 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Feb 2020to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Gastroesophageal cancer Age 18 years or older Able to understand and sign written informed consent
Who cannot join
- Patients not providing informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Morten Mau-Sørensen, MD, PhD, 35450879 ext. 0045, morten.mau-soerensen@regionh.dk
Lene Baeksgaard
About this study
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)
- Conditions
- Esophageal Cancer, Gastric Cancer
- Being tested
- Circulating tumor DNA
- Keywords
- Circulating Tumor DNA
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating tumor DNADiagnostic test
Measurement of circulating tumor DNA from plasma over a period of 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Surgical resection + perioperative chemotherapy | Not described Receives: Diagnostic Test: Circulating tumor DNA | |
| Cohort 2: Neoadjuvant chemoradiotherapy followed by surgery | Not described Receives: Diagnostic Test: Circulating tumor DNA | |
| Cohort 3: Definitive chemoradiotherapy | Not described Receives: Diagnostic Test: Circulating tumor DNA | |
| Cohort 4: Chemotherapy with the aim to prolong life expectancy | Not described Receives: Diagnostic Test: Circulating tumor DNA | |
| Cohort 5: Non-chemotherapeutic palliation | E.g. Palliative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrence
Measured: 1 year
Secondary outcomes (4)
Time to progression
Measured: 1 year
Overall survival
Measured: 5 year
Response rate RECIST 1.1
Measured: through study completion, an average of 1 year
Response duration RECIST 1.1
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start3 Feb 2020
- Primary completionFeb 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Mau-Sørensen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576858
- Sponsor's protocol ID
- CURE
- Acronym
- CURE
- Status last verified
- Sep 2020
- First submitted
- 23 Jan 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer
- ClinicalTrials.gov ID
- NCT04576858
- Acronym / sponsor ID
- CURE / CURE
- Conditions
- Esophageal Cancer, Gastric Cancer
- Keywords
- Circulating Tumor DNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,950 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Surgical resection + perioperative chemotherapy | – | Diagnostic Test: Circulating tumor DNA |
| Cohort 2: Neoadjuvant chemoradiotherapy followed by surgery | – | Diagnostic Test: Circulating tumor DNA |
| Cohort 3: Definitive chemoradiotherapy | – | Diagnostic Test: Circulating tumor DNA |
| Cohort 4: Chemotherapy with the aim to prolong life expectancy | – | Diagnostic Test: Circulating tumor DNA |
| Cohort 5: Non-chemotherapeutic palliation | – | –E.g. Palliative radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Gastroesophageal cancer Age 18 years or older Able to understand and sign written informed consent
Key exclusion criteria (1 listed)
- Patients not providing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating tumor DNAMeasurement of circulating tumor DNA from plasma over a period of 2 years. | Diagnostic test | 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 |
Primary outcome
Time to recurrence
Time frame: 1 year
4 secondary outcomes
Time to progression
Time frame: 1 year
Overall survival
Time frame: 5 year
Response rate RECIST 1.1
Time frame: through study completion, an average of 1 year
Response duration RECIST 1.1
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Gastric Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morten Mau-Sørensen, MD, PhD (35450879 ext. 0045, mms@rh.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recurrence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.