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Patient's Experience and Choice Between Investigations for Endometrial Cancer in Postmenopausal Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330015
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Fung Wen Ying Linda, Chinese University of Hong Kong

Brief Summary:
Endometrial cancer is the most common malignancy of the female genital tract in Hong Kong. The aim in the evaluation of PMB is to exclude underlying malignancy. Endometrial thickness (ET) measured by transvaginal ultrasound scanning (TVS) and endometrial biopsy or sampling (ES) has been recommended as the first-line investigation. From a study between 2002-2013 in the One-stop PMB clinic, investigators found that ET was able to identify women with endometrial cancer with the sensitivity at 3mm, 4mm, and 5mm, the current levels recommended in professional guidelines, being 97.0%, 94.1%, and 93.5% respectively. However, little is known about the level of patient's acceptance of the false negative rate and how patient would trade residual risk with more invasive test. There is also a lack of study on the experience of women during the management pathway especially the level of anxiety before and after investigations and the pain experienced from the investigations offered. The current study aim to study the level of false negative rate accepted by women for the investigation of PMB and the level of anxiety and pain experienced during the investigation pathway.

Condition or disease
Endometrial Cancer Postmenopausal Bleeding

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Study Type : Observational
Actual Enrollment : 206 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient's Experience and Choice Between Investigations for Endometrial Cancer in Postmenopausal Bleeding
Actual Study Start Date : June 3, 2016
Actual Primary Completion Date : June 26, 2017
Actual Study Completion Date : September 26, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. The level of acceptance of false negative rate using TVS ET [ Time Frame: Baseline ]
    The level of acceptance of false negative rate using endometrial thickness assessed by transvaginal ultrasound scanning to identify endometrial cancer.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Our center provides a dedicated Postmenopausal Bleeding Clinic for the one-stop evaluation for PMB in Hong Kong and we receive referrals from other centers in Hong Kong. Our center is a tertiary-care university institution with two affiliated hospitals.All patients who are new referrals for the symptom of PMB will be invited to participate in the study. A woman is considered to have PMB if there is occurrence of bleeding after one completed year of amenorrhoea.
Criteria

Inclusion Criteria:

  • postmenopausal woman
  • referrals for the symptom of PMB

Exclusion Criteria:

  • dementia
  • mental retardation

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): NCT03330015


Locations
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Hong Kong
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Wen Ying Fung Chinese University of Hong Kong
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Responsible Party: Fung Wen Ying Linda, Associate Consultant, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03330015    
Other Study ID Numbers: CREC 2015.437
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fung Wen Ying Linda, Chinese University of Hong Kong:
postmenopausal bleeding
endometrial cancer
Patient's experience
Patient's choice
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Hemorrhage
Hemorrhage
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases