Esophageal Neoplasm Clinical Trial
Official title:
Endodrill vs. Conventional Biopsy. Diagnostics and Genetic Analysis in Tumors of the Distal Esophagus and Cardia
NCT number | NCT02601079 |
Other study ID # | Endodrill I |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | June 2019 |
Verified date | March 2020 |
Source | Region Skane |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Endodrill is a new instrument for biopsy sampling in the GI-channel. The purposes of this
study are as follows:
- Compare the Endodrill instrument with conventional biopsy forceps in terms of ability to
establish the correct diagnosis based on collected biopsies of tumors in the upper GI
tract.
- Based on the quality of the collected tissue samples we want to evaluate which
instrument generates the most useful material for genetic studies of the tumor.
Status | Terminated |
Enrollment | 7 |
Est. completion date | June 2019 |
Est. primary completion date | May 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Patients diagnosed with adenocarcinoma of the distal esophagus/cardia or stomach capable of stating a formal consent to participate in the study. Exclusion Criteria: - Mental illness - Extreme co-morbidity (ASA >3) |
Country | Name | City | State |
---|---|---|---|
Sweden | University Hospital of Lund | Lund | Skane |
Lead Sponsor | Collaborator |
---|---|
Region Skane |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Highest proportion (number) of representative biopsies for diagnostic purposes from the tumor tissue. | 12 months | ||
Secondary | Number of genetic point mutations in tissue harvested from esophageal neoplasms prior to neoadjuvant oncological treatment. | 12 months | ||
Secondary | Number of fusion genes in tissue harvested from esophageal neoplasms prior to neoadjuvant oncological treatment. | 12 months |
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