Genetic Polymorphism and Post Operative Nausea and Vomiting (PONV)

NCT ID: NCT03627780

Last Updated: 2021-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-02

Study Completion Date

2020-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Genetic Predisposition to Disease Postoperative Nausea Polymorphism, Genetic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PONV

Patients presenting with postoperative nausea and vomiting

DNA extraction

Intervention Type DIAGNOSTIC_TEST

DNA will be extracted from white cells

no PONV

Patients not presenting with postoperative nausea and vomiting

DNA extraction

Intervention Type DIAGNOSTIC_TEST

DNA will be extracted from white cells

Interventions

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DNA extraction

DNA will be extracted from white cells

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela M Sousa, phd

Role: PRINCIPAL_INVESTIGATOR

Instituto do Cancer do Estado de São Paulo

Locations

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Cancer Institute of the State of Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

Site Status

Cancer Institute of the State of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 26012530 (View on PubMed)

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):195-202. doi: 10.1188/14.ONF.195-202.

Reference Type RESULT
PMID: 24578078 (View on PubMed)

Grigio TR, Furuya TK, Slullitel A, Murillo Carrasco AG, Uno M, Alves MJF, Carmona MJC, Sugino S, Chammas R, Sousa AM. Clinical, ethnic and genetic risk factors associated with postoperative nausea and vomiting in patients undergoing cancer surgery: a case-control study. Am J Transl Res. 2025 Apr 15;17(4):3235-3246. doi: 10.62347/DGRM3907. eCollection 2025.

Reference Type DERIVED
PMID: 40385041 (View on PubMed)

Other Identifiers

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NP1127/2017

Identifier Type: -

Identifier Source: org_study_id

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