Universal Screening for Lynch Syndrome in Women With Endometrial and Non-Serous Ovarian Cancer (LS2)
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|ClinicalTrials.gov Identifier: NCT02494791|
Recruitment Status : Active, not recruiting
First Posted : July 10, 2015
Last Update Posted : May 17, 2022
|Condition or disease||Intervention/treatment||Phase|
|Lynch Syndrome Endometrial Neoplasms Ovarian Neoplasms Colorectal Neoplasms||Behavioral: Questionnaire, Educational Material||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||886 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Universal Screening for Lynch Syndrome in Women With Endometrial and Non-Serous Ovarian Cancer|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2025|
Endometrial and Ovarian Cancer Participants
All study subjects will be offered the same options for screening and follow-up.
Behavioral: Questionnaire, Educational Material
Participants in this study will be given educational material about Lynch Syndrome and genetic testing for this condition. They will be asked to complete questionnaires about their family cancer history, personal health history and attitudes toward genetic testing.
- Adherence to screening guidelines (colonoscopy and gynecologic risk-reducing surgery) in participants found to have Lynch Syndrome [ Time Frame: short-term assessment at 1 year after diagnosis, long-term assessment for up to 10 years after diagnosis ]Participants found to have Lynch Syndrome will be followed after diagnosis and asked to update the study annually with information about any colorectal cancer screening (colonoscopy) and/or gynecologic risk-reducing surgery they've undergone. This information will be used to assess the success of the enhanced universal screening protocol in helping treat pre-cancerous lesions and therefore prevent a possible cancer as well as aid in detection of early malignancies that otherwise may have gone undetected.
- Cost-effectiveness of universal enhanced screening strategy to identify women with Lynch Syndrome and their family members via cascade testing [ Time Frame: short-term assessment at 1 year after diagnosis, long-term assessment for up to 10 years after diagnosis ]Data about adherence to screening guidelines and the outcome of screening procedures will be used to inform cost-effectiveness models assessing the feasibility of implementing this enhanced universal screening strategy for Lynch Syndrome in institutions across Canada.
- Incidence of Lynch Syndrome in an unselected group of women with endometrial and non-serous ovarian cancer [ Time Frame: 3 years ]This study will add data about the number of Lynch Syndrome cases among a large cohort of endometrial cancer patients in Canada, adding to previous work. This will be the first prospective study to assess Lynch Syndrome incidence in non-serous, non-mucinous ovarian cancer patients in Canada.
- Discovery of novel genetic mutations and molecular events in unexplained MMR loss (Lynch-like Syndrome) [ Time Frame: 3-5 years ]This study will investigate tumour samples from women with unexplained MMR loss (MMR IHC deficient without a germline mutation) to probe what other factors may contribute to Lynch-like Syndrome. Currently these patients are believed to have an intermediate risk for Lynch-associated cancers and are counselled accordingly. Further investigation into the biology of this condition may yield more effective strategies for stratifying and managing risk for Lynch-like Syndrome patients.
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): NCT02494791
|University Health Network - Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5T 2M9|
|Principal Investigator:||Sarah Ferguson, MD||Princess Margaret Cancer Centre|