Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
NCT05361668
Adenocarcinoma, Carcinoid
Los Angeles, California, United States
View Trial DetailsNCT Number: NCT07317713
Carcinoid tumors are rare neuroendocrine tumors with slowly progressive course with the sites are small intestine accounting for 45%, rectum (20%), appendix (17%), colon (11%), and stomach (7%). This study focus on the mortality risk analysis for GI carcinoids due to data insufficiency in the literature.
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Observational
Carcinoid tumors are rare neuroendocrine tumors with slowly progressive course with the sites are small intestine accounting for 45%, rectum (20%), appendix (17%), colon (11%), and stomach (7%). This study focus on the mortality risk analysis for GI carcinoids due to data insufficiency in the literature. This is a retrospective cohort study based on the Surveillance, Epidemiology, and End Results (SEER) database using SEER*Stat software covering approximately 28% of the U.S. The inclusion criteria involved all patients with primary malignant GI carcinoid tumor diagnosed between 2000 and 2021 with sequence number 0 or 1. Sequence 0 indicated the patient had only one cancer record while sequence 1 indicated the patient may had developed many cancer records following the first one. In addition, the tumors were restricted to malignant behavior codes (ICD-O-3 Code 3). We used SEER*Stat software (version 9.0.42.0) to conduct data extraction and statistical analysis. We used the MP-SIR session to calculate the SMR as Observed/Expected (O/E) with a 95% confidence interval (CI) and the excess risk (ER) was per 10,000. Statistical significance was achieved at 0.05. With further analysis, we compared cancer as a cause of death (COD) to other non-cancer COD across different time intervals and primary sites among GI carcinoid tumour.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2000-2022
SEER*Stat software (version 9.0.42.0) was used to conduct data extraction and statistical analysis. The MP-SIR session was used to calculate the SMR as Observed/Expected (O/E) with a 95% confidence interval (CI) and the excess risk was per 10,000. Statistical significance was achieved at 0.05. With further analysis, we compared cancer as a cause of death to other non-cancer causes of death across different time intervals and primary sites among GI carcinoid tumour.
Suez Canal University
Other
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