Endometrial sampling with vaginal tampons during gynaecological screening in women with Lynch syndrome

Endometrial sampling with vaginal tampons during gynaecological screening in women with Lynch syndrome - Endometrial sampling with tampons in women with Lynch syndrome

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43351

Enrollment

Registered

2016-10-06

Start date

2017-01-17

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer of the womb endometrial cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women who are carier of Lynch syndrome or first degree relatives at 50% risk of het Lynch syndrome who get annual gynaecological surveillance from the age of 30-35 years. Women who have a uterus

Exclusion criteria

Exclusion criteria: Women without the Lynch syndrome gene mutation or who are not a first degree relative with 50% risk of Lynch syndrome Women without a uterus. Women with Lynch syndrome under age 30

Design outcomes

Primary

Measure	Time frame
Primary outcomes: 1. The quality of the cells obtained with tampons a. Are there enough cells to perform an adequate analysis b. Are the cells of sufficient quality for analysis 2. Are the number and the quality of the cells adequate to analyse if the endometrial cells are normal or abnormal? 3. Is the diagnosis obtained with the cells at the tampons comparable with the tissue obtained by endometrial sampling for every patient 4. Is there an opportunity to perform immunohistochemical detection methods on the cells obtained by tampons for detection of loss of MLH1-, MSH2-, MSH6- of PMS2- proteins. 5. The level of pain with collecting endometrial cells by using tampons will be measured with the VAS score. This will be compared with the VAS score during the standard endometrial sampling 6. The level of discomfort of endometrial sampling by using the tampons will be measured, are women willing to get surveillance with tampons again and is there a preference above standard endometrial sampling?	—

Measure

Time frame

Primary outcomes: 1. The quality of the cells obtained with tampons a. Are there enough cells to perform an adequate analysis b. Are the cells of sufficient quality for analysis 2. Are the number and the quality of the cells adequate to analyse if the endometrial cells are normal or abnormal? 3. Is the diagnosis obtained with the cells at the tampons comparable with the tissue obtained by endometrial sampling for every patient 4. Is there an opportunity to perform immunohistochemical detection methods on the cells obtained by tampons for detection of loss of MLH1-, MSH2-, MSH6- of PMS2- proteins. 5. The level of pain with collecting endometrial cells by using tampons will be measured with the VAS score. This will be compared with the VAS score during the standard endometrial sampling 6. The level of discomfort of endometrial sampling by using the tampons will be measured, are women willing to get surveillance with tampons again and is there a preference above standard endometrial sampling?

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Countries

Netherlands

Outcome results