Gynecologic CancerNCT03740672
Adherence to the Antiemesis National Comprehensive Cancer Network (NCCN) Guideline
An observational study of Gynecologic Cancer and Chemotherapy-induced Nausea and Vomiting, run by Lei Li at 1 site in China.
Trial summary
This study aims to investigate the adherence to the antiemesis NCCN guideline in Chinese patients of gynecologic malignancies, who are given chemotherapy treatment. The risk of chemotherapy induced nausea and vomiting (CINV) is calculated by the questionnaire supported by the website "CINV Risk Assessment"… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Chemotherapy-induced Nausea and Vomiting
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2018to 1 Dec 2019
- 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
- Women only
- Adult, Older adult
Study population: All patients who are given chemotherapy treatment for gynecologic malignancies are included.
Who may be able to join
- Good performance status
- Aged 18 years or older
- Signed an approved informed consents
Who cannot join
- Not meeting all of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 008613911988831, lileigh@163.com
About this study
Official title: Adherence to the Antiemesis National Comprehensive Cancer Network (NCCN) Guideline in Chinese Patients of Gynecologic Malignancies
This study aims to investigate the adherence to the antiemesis NCCN guideline in Chinese patients of gynecologic malignancies, who are given chemotherapy treatment. The risk of chemotherapy induced nausea and vomiting (CINV) is calculated by the questionnaire supported by the website "CINV Risk Assessment" (http://www.riskcinv.org/).
- Medical subject headings
- Vomiting
What is being measured
The primary outcome is the main question the study is designed to answer.
risk of chemotherapy induced nausea and vomiting
The risk of chemotherapy induced nausea and vomiting is calculated by the questionnaire supported by the website "CINV Risk Assessment" (http://www.riskcinv.org/). The difference of patients adhered to and not to NCCN guideline is compared.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start22 Nov 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740672
- Sponsor's protocol ID
- GO-CINV
- Status last verified
- Nov 2018
- First submitted
- 10 Nov 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to the Antiemesis National Comprehensive Cancer Network (NCCN) Guideline in Chinese Patients of Gynecologic Malignancies
- ClinicalTrials.gov ID
- NCT03740672
- Acronym / sponsor ID
- GO-CINV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 14 Nov 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.
This study aims to investigate the adherence to the antiemesis NCCN guideline in Chinese patients of gynecologic malignancies, who are given chemotherapy treatment. The risk of chemotherapy induced nausea and vomiting (CINV) is calculated by the questionnaire supported by the website "CINV Risk Assessment" (http://www.riskcinv.org/).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- All patients who are given chemotherapy treatment for gynecologic malignancies are included.
Key inclusion criteria (3 listed)
- Good performance status
- Aged 18 years or older
- Signed an approved informed consents
Key exclusion criteria (1 listed)
- Not meeting all of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
risk of chemotherapy induced nausea and vomiting
Time frame: One year
The risk of chemotherapy induced nausea and vomiting is calculated by the questionnaire supported by the website "CINV Risk Assessment" (http://www.riskcinv.org/). The difference of patients adhered to and not to NCCN guideline is compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
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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.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer and Chemotherapy-induced Nausea and Vomiting, run by Lei Li at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Li, M.D. (8613911988831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risk of chemotherapy induced nausea and vomiting (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2018.