Adherence to the Antiemesis National Comprehensive Cancer... | NCT03740672

Studies
Adherence to the Antiemesis National Comprehensive Cancer Network (NCCN) Guideline

NCT03740672

Sponsor

Lei Li

Status

Unknown status

Last Update Posted

Nov 26, 2018Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Gynecologic Cancer
Chemotherapy-induced Nausea and Vomiting

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 22, 2018Actual

Primary Completion Date

Dec 1, 2019Estimated

Completion Date

Dec 1, 2019Estimated

First Submitted Date

Nov 10, 2018

First Submission Date that Met QC Criteria

Nov 10, 2018

First Posted Date

Nov 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2018

Last Update Posted Date

Nov 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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" (http://www.riskcinv.org/).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Good performance status
Aged 18 years or older
Signed an approved informed consents

Exclusion Criteria:

Not meeting all of the inclusion criteria

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients who are given chemotherapy treatment for gynecologic malignancies are included.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lei Li, M.D.	Contact	8613911988831		lileigh@163.com

Overall Officials

Name	Affiliation	Role
Lei Li, M.D.	Peking Union Medical College Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lei Li	Recruiting	Beijing	Beijing Municipality	100730	China

Condition Browse Module

MeSH Terms

ID	Term
D014839	Vomiting

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided