Status:
UNKNOWN
Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Gastric NET
Eligibility:
All Genders
18-80 years
Brief Summary
This study evaluates the efficacy of Long-acting Somastostatin analogs as treatment for type I gastric neuroendocrine tumors.
Eligibility Criteria
Inclusion
- Histologic diagnosis of gastric neuroendocrine tumor.
- Clinical diagnosis of Type I gastric NET: neuroendocrine tumor arising from atrophic body gastritis (ABG diagnosis should be based on hypergastrinemia and histological confirmation of gastric body atrophy on multiple biopsies performed in gastric antrum and body).
- Previous esophagogastroduodenoscopy: all visible NETs resected with R0 margin, confirmed no visible gastric NETs left, multiple biopsies taken to evaluate gastric atrophy and ECL status.
- No tumor metastases confirmed by endoscopic ultrasonography, CT scan or somatostatin receptor scintigraphy.
- SSA therapy is recommended by physician for disease management, and has not yet begun.
- Written informed consent obtained prior to treatment to be consistent with local regulatory requirements.
Exclusion
- Pathological grading as G3 NET (Ki-67\>20%).
- Patients with a known hypersensitivity to somatostatin analogs.
- Known gallbladder or bile duct disease, acute or chronic pancreatitis.
- Known medical condition related with prolonged QT interval.
- Pregnant or lactating women.
- Patients with serious complicated infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy.
- Patients with any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. Patients with previous malignancies but without evidence of disease for \> 5 years will be allowed to enter the trial.
- Patients with a history of non-compliance to medical regimens.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03812939
Start Date
January 1 2019
End Date
December 31 2020
Last Update
January 23 2019
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730