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NCT03627780 Clinical Trial

Genetic Polymorphism and Post Operative Nausea and Vomiting (PONV)

Genetic Predisposition to Disease Clinical Trial

— ponv  

Official title:
Genetic Polymorphism Associated With the Occurrence of Postoperative Vomiting and Vomiting (PONV) in Patients Undergoing Oncological Surgeries

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03627780
Other study ID # NP1127/2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2017
Est. completion date March 1, 2020

Study information
Verified date May 2021
Source Instituto do Cancer do Estado de São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Nausea and vomiting affects 25-30% of individuals in the post-operative period and can reach more than 70-80% in high-risk patients. inherited factors may play a significant role in individual susceptibility and clinical research on hereditary factors involved in the pathogenesis of Postoperative nausea and vomiting (PONV) and chemotherapy nausea and vomiting (CINV) is relatively new. The aim of this study is to investigate whether inter-individual differences related to PONV are associated with genetic factors. 300 patients will be evaluated in postoperative oncological surgeries. The peripheral leukocyte DNA will be extracted by the Salting Out Procedure method and processed to genotyping for 48 SNPs from 15 candidate genes by real-time PCR by the Taqman method. The possible associations with demographic data and factors related to surgery will be analyzed by univariate and multivariate analysis.

Description:

The aim of this study is to investigate whether inter-individual differences related to PONV are associated with genetic factors. 300 patients will be evaluated in postoperative oncological surgeries. The peripheral leukocyte DNA will be extracted by the Salting Out Procedure method and processed to genotyping for 48 single nucleotide polymorphisms (SNPs) from 15 candidate genes by real-time PCR by the Taqman method. The possible associations with demographic data and factors related to surgery will be analyzed by univariate and multivariate analysis.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - High and intermediate-risk patients for PONV (Apfel score 2, 3 and 4) Exclusion Criteria: - Low risk patients for PONV (Apfel score 0 and 1)

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• DNA extraction
DNA will be extracted from white cells

Locations
Country Name City State
Brazil Cancer Institute of the State of Sao Paulo Sao Paulo São Paulo
Brazil Cancer Institute of the State of Sao Paulo - ICESP Sao Paulo São Paulo

Sponsors (2)
Lead Sponsor Collaborator
Instituto do Cancer do Estado de São Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Hayase T, Sugino S, Moriya H, Yamakage M. TACR1 gene polymorphism and sex differences in postoperative nausea and vomiting. Anaesthesia. 2015 Oct;70(10):1148-59. doi: 10.1111/anae.13082. Epub 2015 May 27. — View Citation

Wesmiller SW, Bender CM, Sereika SM, Ahrendt G, Bonaventura M, Bovbjerg DH, Conley Y. Association between serotonin transport polymorphisms and postdischarge nausea and vomiting in women following breast cancer surgery. Oncol Nurs Forum. 2014 Mar 1;41(2): — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary PONV (Post operative nausea and vomiting) Incidence of early (6 hours) and late (24 h) nausea and vomiting 24 hours
Secondary Intensity of Acute Postoperative pain Intensity of Postoperative pain measures by numerical rate scale and descriptive scale will be assessed in the first 24 hours in all patients 24 hours
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