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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02610764 |
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Date of registration:
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15/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pilot Sudy: Resectable Esophageal Adenocarcinoma and the Relevance of CTC
ESO-CTC |
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Scientific title:
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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 |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02610764 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Birte Kulemann, Dr. med. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Freiburg |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Esophageal Adenocarcinoma
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Intervention(s)
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Procedure: Blood Test for CTC evaluation
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Primary Outcome(s)
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Change of numbers of CTCs in patients with resectable EAC at diagnosis, after neoadjuvant treatment and after surgery.
[Time Frame: 1 year]
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Secondary Outcome(s)
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Number of patients with detectable CTCs at diagnosis, after neoadjuvant treatment and after surgery.
[Time Frame: 1 year]
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Secondary ID(s)
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ESO-CTC (Pilot)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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