ponv: Genetic Polymorphism and Post Operative Nausea and Vomiting (PONV)

• Sponsor: Instituto do Cancer do Estado de São Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT03627780
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
• Enrollment: 300
• Locations: 2
• Actual Duration (Months): 37.9
• Patients Per Site: 150
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Genetic Predisposition to Disease; Postoperative Nausea; Polymorphism, Genetic	Diagnostic Test: DNA extraction

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 300 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Genetic Polymorphism Associated With the Occurrence of Postoperative Vomiting and Vomiting (PONV) in Patients Undergoing Oncological Surgeries
• Actual Study Start Date: Jan 2, 2017
• Actual Primary Completion Date: Mar 1, 2020
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
PONV Patients presenting with postoperative nausea and vomiting	Diagnostic Test: DNA extraction; DNA will be extracted from white cells
no PONV Patients not presenting with postoperative nausea and vomiting	Diagnostic Test: DNA extraction; DNA will be extracted from white cells

Outcome Measures

Primary Outcome Measures

1. PONV (Post operative nausea and vomiting) [24 hours]

   Incidence of early (6 hours) and late (24 h) nausea and vomiting

Secondary Outcome Measures

1. Intensity of Acute Postoperative pain [24 hours]

   Intensity of Postoperative pain measures by numerical rate scale and descriptive scale will be assessed in the first 24 hours in all patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Institute of the State of Sao Paulo - ICESP	Sao Paulo	São Paulo	Brazil	01403010
2	Cancer Institute of the State of Sao Paulo	Sao Paulo	São Paulo	Brazil	01403010

Sponsors and Collaborators

• Instituto do Cancer do Estado de São Paulo
• Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

• Principal Investigator: Angela M Sousa, phd, Instituto do Cancer do Estado de São Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Instituto do Cancer do Estado de São Paulo
• ClinicalTrials.gov Identifier: NCT03627780
• Other Study ID Numbers: NP1127/2017
• First Posted: Aug 13, 2018
• Last Update Posted: May 19, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting; Disease Susceptibility; Genetic Predisposition to Disease

Study Results

No Results Posted as of May 19, 2021