Esophageal AdenocarcinomaESO-CTCNCT02610764
Pilot Sudy: Resectable Esophageal Adenocarcinoma and the Relevance of CTC
A study testing Blood Test for CTC evaluation in people with Esophageal Adenocarcinoma, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
To investigate the feasibility of evaluation of prevalence and clinical significance and relevance of circulating tumor cells (CTC) in the blood of patients with resectable adenocarcinoma of the esophagus (EAC) treated with multimodal therapy in a pilot study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Adenocarcinoma
- What is being tested?
- Blood Test for CTC evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2015to Dec 2016
- Phase
- Interventional
- 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
Who may be able to join
- Histologically verified adenocarcinoma of the esophagus According to the UICC definition (TNM7),
- pre-treatment stage cT1N+, M0 or cT2-4aN0/N+, M0 ,
- Age≥18 years,
- scheduled for a multimodal therapeutic concept.
Who cannot join
- Tumors of squamous, adenosquamous or other non-adenocarcinoma histology, patients with advanced inoperable or metastatic esophageal adenocarcinoma.
- Esophageal adenocarcinoma cT1N0 and cT4b,
- Gastric carcinoma.
- Prior chemotherapy for gastrointestinal cancer. Clinically not eligible for surgery
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Freiburg - Medical Center
Freiburg im Breisgau, Baden-Würtemberg, 79106
About this study
Official title: Resectable Esophageal Adenocarcinoma: The Influence of Multimodal Therapy on the Prevalence and Enumeration of Circulating Tumor Cells in Comparison With Conventional Response Evaluation in a Feasibility Study
To investigate the feasibility of evaluation of prevalence and clinical significance and relevance of circulating tumor cells (CTC) in the blood of patients with resectable adenocarcinoma of the esophagus (EAC) treated with multimodal therapy in a pilot study. The primary hypothesis is that the number of CTC correlates with tumor burden and response to treatment. One established and one experimental CTC detection platform will be investigated. Investigators will evaluate the prevalence and enumeration of CTC before neoadjuvant treatment (time point 1), after neoadjuvant treatment \& before operation (time point 2) and after the operation (time point 3). Results will be compared with healthy controls (one time point) and correlated with conventional response to treatment evaluation. The persistent presence of CTC could be a marker for worse response to treatment and predict early recurrence.
Read the detailed description
Little is known of the prevalence and clinical relevance of CTC in EAC, with the available data arising from heterogeneous patient populations using varied detection methods; but they are promising tools to improve staging and prediction of treatment response to perioperative and operative therapy.
The limited reports on resectable EAC use the epithelial-antibody dependent CellSearch method for CTC isolation and report a CTC-positivity rate of only 15-18% in non-pre-treated patients but with clinical relevance. It is thus needed to evaluate the relevance of CTC in the context of multimodal treatment courses.
This pilot study will investigate the CTC in the blood of patients with resectable EAC treated with multimodal therapy. Data on prevalence and enumeration of CTC will be generated. Two CTC isolation methods will be investigated, the established and expensive surface-antibody-dependent CellSearch method, and the antibody-independent and less expensive isolation by size (ISET; ScreenCell) method. The ISET method will additionally be investigated in healthy controls to get data on specificity.
The study can accomplish several goals through the use of two CTC detection platforms: 1) to determine the prevalence and number of CTC in resectable EAC under multimodal treatment, and 2) to investigate the potential role of CTC in predicting response to treatment and prognosis before neoadjuvant treatment, after neoadjuvant treatment and before operation as well as after the operation.
The primary hypothesis is that the enumeration of the CTC correlates with tumor burden and will reflect the response to treatment. To date the response to treatment is assessed with a combination of CT-morphologic, endoscopic, clinical (dysphagia) and finally histology. This assessment is used as control.
- Conditions
- Esophageal Adenocarcinoma
- Being tested
- Blood Test for CTC evaluation
- Keywords
- Circulating Tumor Cells, Response evaluation
- Medical subject headings
- Adenocarcinoma Of Esophagus, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Test for CTC evaluationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental diagnostic test | Experimental | Evaluation and enumeration of circulating Tumor cells from the blood with two different CTC-detection platforms: one established test (CellSearch) and one experimental test (ScreenCell).
Control diagnostic test: CT-Scan of the Chest and the Abdomen, Endoscopy and Endosonography, Clinical response and histo pathologic response. (% Of vital tumor Cells in the histologic specimen). Receives: Procedure: Blood Test for CTC evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of numbers of CTCs in patients with resectable EAC at diagnosis, after neoadjuvant treatment and after surgery.
Measured: 1 year
Secondary outcomes (1)
Number of patients with detectable CTCs at diagnosis, after neoadjuvant treatment and after surgery.
Number of patients with detectable CTCs isolated with the ISET device compared to the CellSearch method.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AdenocarcinomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Birte Kulemann, University Hospital Freiburg
- Investigators
- Birte Kulemann, Dr. med., Principal investigator, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610764
- Sponsor's protocol ID
- ESO-CTC (Pilot)
- Acronym
- ESO-CTC
- Status last verified
- Apr 2017
- First submitted
- 15 Nov 2015
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resectable Esophageal Adenocarcinoma: The Influence of Multimodal Therapy on the Prevalence and Enumeration of Circulating Tumor Cells in Comparison With Conventional Response Evaluation in a Feasibility Study
- ClinicalTrials.gov ID
- NCT02610764
- Acronym / sponsor ID
- ESO-CTC / ESO-CTC (Pilot)
- Conditions
- Esophageal Adenocarcinoma
- Keywords
- Circulating Tumor Cells, Response evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Nov 2015 (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.
To investigate the feasibility of evaluation of prevalence and clinical significance and relevance of circulating tumor cells (CTC) in the blood of patients with resectable adenocarcinoma of the esophagus (EAC) treated with multimodal therapy in a pilot study. The primary hypothesis is that the number of CTC correlates with tumor burden and response to treatment. One established and one experimental CTC detection platform will be investigated. Investigators will evaluate the prevalence and enumeration of CTC before neoadjuvant treatment (time point 1), after neoadjuvant treatment \& before operation (time point 2) and after the operation (time point 3). Results will be compared with healthy controls (one time point) and correlated with conventional response to treatment evaluation. The persistent presence of CTC could be a marker for worse response to treatment and predict early recurrence.
Detailed description
Little is known of the prevalence and clinical relevance of CTC in EAC, with the available data arising from heterogeneous patient populations using varied detection methods; but they are promising tools to improve staging and prediction of treatment response to perioperative and operative therapy.
The limited reports on resectable EAC use the epithelial-antibody dependent CellSearch method for CTC isolation and report a CTC-positivity rate of only 15-18% in non-pre-treated patients but with clinical relevance. It is thus needed to evaluate the relevance of CTC in the context of multimodal treatment courses.
This pilot study will investigate the CTC in the blood of patients with resectable EAC treated with multimodal therapy. Data on prevalence and enumeration of CTC will be generated. Two CTC isolation methods will be investigated, the established and expensive surface-antibody-dependent CellSearch method, and the antibody-independent and less expensive isolation by size (ISET; ScreenCell) method. The ISET method will additionally be investigated in healthy controls to get data on specificity.
The study can accomplish several goals through the use of two CTC detection platforms: 1) to determine the prevalence and number of CTC in resectable EAC under multimodal treatment, and 2) to investigate the potential role of CTC in predicting response to treatment and prognosis before neoadjuvant treatment, after neoadjuvant treatment and before operation as well as after the operation.
The primary hypothesis is that the enumeration of the CTC correlates with tumor burden and will reflect the response to treatment. To date the response to treatment is assessed with a combination of CT-morphologic, endoscopic, clinical (dysphagia) and finally histology. This assessment is used as control.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental diagnostic test | Experimental | Procedure: Blood Test for CTC evaluationEvaluation and enumeration of circulating Tumor cells from the blood with two different CTC-detection platforms: one established test (CellSearch) and one experimental test (ScreenCell). Control diagnostic test: CT-Scan of the Chest and the Abdomen, Endoscopy and Endosonography, Clinical response and histo pathologic response. (% Of vital tumor Cells in the histologic specimen). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically verified adenocarcinoma of the esophagus According to the UICC definition (TNM7),
- pre-treatment stage cT1N+, M0 or cT2-4aN0/N+, M0 ,
- Age≥18 years,
- scheduled for a multimodal therapeutic concept.
Key exclusion criteria (4 listed)
- Tumors of squamous, adenosquamous or other non-adenocarcinoma histology, patients with advanced inoperable or metastatic esophageal adenocarcinoma.
- Esophageal adenocarcinoma cT1N0 and cT4b,
- Gastric carcinoma.
- Prior chemotherapy for gastrointestinal cancer. Clinically not eligible for surgery
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 |
|---|---|---|
| Blood Test for CTC evaluation | Procedure or surgery | Experimental diagnostic test |
Primary outcome
Change of numbers of CTCs in patients with resectable EAC at diagnosis, after neoadjuvant treatment and after surgery.
Time frame: 1 year
1 secondary outcome
Number of patients with detectable CTCs at diagnosis, after neoadjuvant treatment and after surgery.
Time frame: 1 year
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 13 Apr 2017.
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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.
Birte Kulemann, Dr. med. principal investigator
University Hospital Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Test for CTC evaluation in people with Esophageal Adenocarcinoma, run by University Hospital Freiburg 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 4 inclusion and 4 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 13 Apr 2017. 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?
Change of numbers of CTCs in patients with resectable EAC at diagnosis, after neoadjuvant treatment and after surgery. (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 13 Apr 2017.