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

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ClinicalTrials.gov Identifier: NCT03627780
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo

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
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.

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Study Type : Observational
Estimated 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 : January 2, 2017
Estimated Primary Completion Date : June 2, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Polymorphism associated to PONV [ Time Frame: 24 hours ]
    Genetic polymorphism of candidate genes associated to PONV or noPONV


Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
300 Patients submitted to cancer surgery, classified as high-risk for PONV according to Apfel Score, 150 cases and 150 controls.
Criteria

Inclusion Criteria:

  • High-risk patients for PONV

Exclusion Criteria:

  • Low risk patients for PONV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627780


Contacts
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Contact: Angela Sousa 5511985588339 angela.sousa@hc.fm.usp.br
Contact: ALEXANDRE SLULLITEL 5511981057525 alexandre.slullitel@gmail.com

Locations
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Brazil
Cancer Institute of the State of Sao Paulo - ICESP Recruiting
Sao Paulo, São Paulo, Brazil, 01403010
Contact: angela sousa, phD    3893-2000 ext 6680    angela.sousa@icesp.org.br   
Sub-Investigator: Leonardo oooooo, MD         
Principal Investigator: angela m sousa, phD         
Sub-Investigator: hazem a ashmawi, phD         
Cancer Institute of the State of Sao Paulo Recruiting
Sao Paulo, São Paulo, Brazil, 01403010
Contact: angela sousa, PhD    2661 ext 6680    angela.sousa@hc.fm.usp.br   
Principal Investigator: angela m sousa, PhD         
Sub-Investigator: alexandre slullitel, MD         
Sub-Investigator: Roger Chammas, PhD         
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Angela M Sousa, phd Instituto do Cancer do Estado de São Paulo

Publications of Results:
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Responsible Party: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT03627780     History of Changes
Other Study ID Numbers: NP1127/2017
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The researchers make a plan to share informations via Red Cap

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Disease Susceptibility
Genetic Predisposition to Disease
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Disease Attributes