Genetic Predisposition to DiseaseponvNCT03627780
Genetic Polymorphism and Post Operative Nausea and Vomiting (PONV)
An observational study of Genetic Predisposition to Disease and Postoperative Nausea, run by Instituto do Cancer do Estado de São Paulo at 2 sites in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genetic Predisposition to Disease, Postoperative Nausea, Polymorphism, Genetic
- What is being tested?
- DNA extraction
- How many people
- 300 participants
- Where
- 2 sitesBrazil
- Study dates
- 2 Jan 2017to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 300 Patients submitted to cancer surgery, classified as high- and intermediate-risk for PONV according to Apfel Score, 150 cases and 150 controls.
Who may be able to join
- High and intermediate-risk patients for PONV (Apfel score 2, 3 and 4)
Who cannot join
- Low risk patients for PONV (Apfel score 0 and 1)
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Cancer Institute of the State of Sao Paulo - ICESP
São Paulo, São Paulo, 01403010
Cancer Institute of the State of Sao Paulo
São Paulo, São Paulo, 01403010
About this study
Official title: Genetic Polymorphism Associated With the Occurrence of Postoperative Vomiting and Vomiting (PONV) in Patients Undergoing Oncological Surgeries
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.
Read the 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.
- Being tested
- DNA extraction
- Medical subject headings
- Genetic Predisposition to Disease, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA extractionDiagnostic test
DNA will be extracted from white cells
| Study group | Role | What they receive |
|---|---|---|
| PONV | Patients presenting with postoperative nausea and vomiting Receives: Diagnostic Test: DNA extraction | |
| no PONV | Patients not presenting with postoperative nausea and vomiting Receives: Diagnostic Test: DNA extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
PONV (Post operative nausea and vomiting)
Incidence of early (6 hours) and late (24 h) nausea and vomiting
Measured: 24 hours
Secondary outcomes (1)
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start2 Jan 2017
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Genetic Predisposition to DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Angela M Sousa, phd, Principal investigator, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627780
- Sponsor's protocol ID
- NP1127/2017
- Acronym
- ponv
- Status last verified
- May 2021
- First submitted
- 9 Aug 2018
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The researchers make a plan to share informations via Red Cap
Publications
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.
PubMed 26012530Wesmiller 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.
PubMed 24578078Grigio 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.
PubMed 40385041
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Polymorphism Associated With the Occurrence of Postoperative Vomiting and Vomiting (PONV) in Patients Undergoing Oncological Surgeries
- ClinicalTrials.gov ID
- NCT03627780
- Acronym / sponsor ID
- ponv / NP1127/2017
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PONV | – | Diagnostic Test: DNA extractionPatients presenting with postoperative nausea and vomiting |
| no PONV | – | Diagnostic Test: DNA extractionPatients not presenting with postoperative nausea and vomiting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 Patients submitted to cancer surgery, classified as high- and intermediate-risk for PONV according to Apfel Score, 150 cases and 150 controls.
Key inclusion criteria (1 listed)
- High and intermediate-risk patients for PONV (Apfel score 2, 3 and 4)
Key exclusion criteria (1 listed)
- Low risk patients for PONV (Apfel score 0 and 1)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA extractionDNA will be extracted from white cells | Diagnostic test | PONV, no PONV |
Primary outcome
PONV (Post operative nausea and vomiting)
Time frame: 24 hours
Incidence of early (6 hours) and late (24 h) nausea and vomiting
1 secondary outcome
Intensity of Acute Postoperative pain
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Results publication: PubMed 26012530Hayase 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.
- Results publication: PubMed 24578078Wesmiller 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.
- Derived from this study: PubMed 40385041Grigio 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.
- Individual participant dataSharing planned: Undecided. The researchers make a plan to share informations via Red Cap
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela M Sousa, phd principal investigator
Instituto do Cancer do Estado de São Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Predisposition to Disease and Postoperative Nausea, run by Instituto do Cancer do Estado de São Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PONV (Post operative nausea and vomiting) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03627780, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.