Resectable Esophageal CancerNCT01858805
Circulating Tumor Cells as a Biomarker for Preoperative Prognostic Staging in Patients With Esophageal Cancer
An observational study of Resectable Esophageal Cancer, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Despite the availability of several preoperative diagnostic techniques, accurate pretreatment staging of esophageal cancer (EC) remains challenging. Therefore, The investigators evaluated the prognostic significance of circulating tumor cells (CTCs) in patients with EC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Esophageal Cancer
- What is being tested?
- esophagectomy
- Type of treatment
- Surgery or procedure
- How many people
- 123 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Apr 2014
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This prospective, single-institution study conducted at the University Hospital Hamburg-Eppendorf (Hamburg, Germany) enrolled 123 patients with ECs that were initially considered resectable.
Who may be able to join
- > 18 years
- resectable esophageal cancer
Who cannot join
- < 18 years
- esophageal cancer with preoperative distant metastases
Trial locations and contacts
1 site in 1 country.
About this study
Despite the availability of several preoperative diagnostic techniques, accurate pretreatment staging of esophageal cancer (EC) remains challenging. Therefore, The investigators evaluated the prognostic significance of circulating tumor cells (CTCs) in patients with EC.
- Conditions
- Resectable Esophageal Cancer
- Being tested
- esophagectomy
- Keywords
- esophagus carcinoma, surgery, circulating tumor cells
- Medical subject headings
- Esophageal Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophagectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| detection of circulating tumors cells | This prospective, single-institution study conducted at the University Hospital Hamburg-Eppendorf (Hamburg, Germany) enrolled 123 patients with ECs that were initially considered resectable. Only patients with histologically proven EC were included. Peripheral blood samples for CTC analysis were collected immediately before surgery. Receives: Procedure: esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 2 years
Secondary outcomes (1)
recurrence-free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startApr 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Matthias Reeh, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858805
- Sponsor's protocol ID
- CTC-EC
- Other IDs
- 184
- Status last verified
- Nov 2014
- First submitted
- 14 May 2013
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor Cells as a Biomarker for Preoperative Prognostic Staging in Patients With Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01858805
- Acronym / sponsor ID
- CTC-EC
- Conditions
- Resectable Esophageal Cancer
- Keywords
- esophagus carcinoma, surgery, circulating tumor cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 May 2013 (estimated)
- 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.
Despite the availability of several preoperative diagnostic techniques, accurate pretreatment staging of esophageal cancer (EC) remains challenging. Therefore, The investigators evaluated the prognostic significance of circulating tumor cells (CTCs) in patients with EC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| detection of circulating tumors cells | – | Procedure: esophagectomyThis prospective, single-institution study conducted at the University Hospital Hamburg-Eppendorf (Hamburg, Germany) enrolled 123 patients with ECs that were initially considered resectable. Only patients with histologically proven EC were included. Peripheral blood samples for CTC analysis were collected immediately before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective, single-institution study conducted at the University Hospital Hamburg-Eppendorf (Hamburg, Germany) enrolled 123 patients with ECs that were initially considered resectable.
Key inclusion criteria (2 listed)
- > 18 years
- resectable esophageal cancer
Key exclusion criteria (2 listed)
- < 18 years
- esophageal cancer with preoperative distant metastases
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 |
|---|---|---|
| esophagectomy | Procedure or surgery | detection of circulating tumors cells |
Primary outcome
overall survival
Time frame: 2 years
1 secondary outcome
recurrence-free survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Resectable Esophageal Cancer, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 18 Nov 2014. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 2 years). 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 18 Nov 2014.