Gastric Cancer Clinical Trial
Official title:
Endoscopic Resection: A Retrospective and Prospective Multicenter Registry
This is a retrospective and prospective multicenter registry to collect long-term data (1
year) on patients who have or will undergo Endoscopic resection such as EMR, ESD, EFTR,
STER, etc. within the gastrointestinal tract for endoscopic treatment of early
gastrointestinal neoplasms involving the resection of the superficial layers, mucosa and
submucosa, of the tract wall.
Subjects will be consented for medical chart review.
The purpose of this retrospective and prospective registry is to assess long term data on
efficacy, safety and clinical outcome of Endoscopic Resection within the gastrointestinal
tract (1 year).
The registry will evaluate efficacy, technical feasibility, clinical outcome, safety profile
and overall clinical management through medical chart review. The procedures the
investigators are evaluating are all clinically indicated and will not be prescribed to
someone to participate in this registry study.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | April 2020 |
Est. primary completion date | March 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Any patient who is considering undergoing endoscopic resection within 6 months, or has undergone clinically indicated endoscopic resection within the past 6 months - Above or equal to 18 years of age. Exclusion Criteria: - Any patient who has not undergone or will undergo endoscopic resection - Below 18 years of age. |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medical College | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of participants with successful completion of treatment | Number of participants with successful completion of treatment | 30 days post procedure | |
Primary | Number of participants with reduction in clinical symptoms | To assess resolution of symptoms of all Endoscopic resection procedures at 6 months | 6 months from procedure | |
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Number of subjects with Adverse Events; Type, frequency and intensity of adverse events within 30 days of procedure | 30 days post procedure |
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