Clinical trial NCT03812939: Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs
Official title: An Observational Study Investigating Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric NET
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type I gastric NET patients from tertiary medical center

Brief summary: This study evaluates the efficacy of Long-acting Somastostatin analogs as treatment for type I gastric neuroendocrine tumors.


Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence rate
timeFrame: 1 year
Secondary outcomes:
measure: Change in clinical symptoms
timeFrame: 6 months to 1 year
measure: Concentration of serum Gastrin
timeFrame: 6 months to 1 year
measure: Enterochromaffin-like cell (ECL) status
timeFrame: 6 months to 1 year
measure: Presence of side-effects of Octreotide
timeFrame: 6 months to 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
citation: 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. No abstract available.
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.
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. doi: 10.1159/000199786.