Gastric NET Clinical Trial
Official title:
An Observational Study Investigating Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs
| NCT number | NCT03812939 |
| Other study ID # | ZS-1788 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 1, 2019 |
| Est. completion date | December 31, 2020 |
This study evaluates the efficacy of Long-acting Somastostatin analogs as treatment for type I gastric neuroendocrine tumors.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | December 31, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Peking Union Medical College Hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Peking Union Medical College Hospital |
China,
Delle Fave G, O'Toole D, Sundin A, Taal B, Ferolla P, Ramage JK, Ferone D, Ito T, Weber W, Zheng-Pei Z, De Herder WW, Pascher A, Ruszniewski P; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for Gastroduodenal Neuroendocrine Neoplasms. Neuroendocrinology. 2016;103(2):119-24. doi: 10.1159/000443168. Epub 2016 Jan 19. — View Citation
Merola E, Sbrozzi-Vanni A, Panzuto F, D'Ambra G, Di Giulio E, Pilozzi E, Capurso G, Lahner E, Bordi C, Annibale B, Delle Fave G. Type I gastric carcinoids: a prospective study on endoscopic management and recurrence rate. Neuroendocrinology. 2012;95(3):207-13. doi: 10.1159/000329043. Epub 2011 Jul 30. — View Citation
Solcia E, Bordi C, Creutzfeldt W, Dayal Y, Dayan AD, Falkmer S, Grimelius L, Havu N. Histopathological classification of nonantral gastric endocrine growths in man. Digestion. 1988;41(4):185-200. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recurrence rate | 1 year | ||
| Secondary | Change in clinical symptoms | Measured by a questionnaire, including whether the patient presents with dyspepsia, abdominal pain, cramps, bloating, nausea, vomiting, lack of appetite, facial flushing. | 6 months to 1 year | |
| Secondary | Concentration of serum Gastrin | Concentration of serum Gastrin after 12 hours of fasting | 6 months to 1 year | |
| Secondary | Enterochromaffin-like cell (ECL) status | Normal Hyperplasia: ECL cell proliferation with a diameter <150 µm, distinguished in: normal pattern/simple hyperplasia, linear, micronodular and adenomatoid hyperplasia. Dysplasia: ECL cell proliferation >150 but <500 µm. Type I gastric carcinoid: ECL proliferation >500 µm. |
6 months to 1 year | |
| Secondary | Presence of side-effects of Octreotide | Measured by a questionnaire for patients and clinician's report. Including: hypersensitivity, endocrine disorders (abnormal thyroid functions), metabolism and nutrition disorders (abnormal blood glucose), headache, bradycardia or tachycardia, dyspnea, gastrointestinal disorders (diarrhea, abdominal pain, nausea, constipation, flatulence), hepatobiliary disorders, skin disorders, injection site reaction. | 6 months to 1 year |