886 Participants Needed

Screening Method for Lynch Syndrome in Endometrial and Ovarian Cancer

(LS2 Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will maximize identification of women with Lynch Syndrome using an enhanced screening strategy to identify those at risk. These women will be referred to genetic counselling for testing and those found to have Lynch Syndrome will be asked to invite first degree relatives to participate and undergo genetic testing for Lynch Syndrome. Screening guidelines and risk reducing surgery options for participants found to have Lynch Syndrome will be reinforced by the study and adherence to these guidelines will be assessed annually for ten years following Lynch Syndrome diagnosis to assess the impact and cost-effectiveness of this enhanced screening approach.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is the screening method for Lynch syndrome in endometrial and ovarian cancer safe for humans?

The research articles do not provide specific safety data for the screening method, but they discuss its implementation and use in clinical practice, suggesting it is generally considered safe for use in humans.12345

How does the Enhanced Screening Strategy and Genetic Counselling treatment for Lynch Syndrome in endometrial and ovarian cancer differ from other treatments?

This treatment is unique because it focuses on early detection of Lynch Syndrome through enhanced screening methods, such as immunohistochemistry and genetic testing, which can identify DNA repair defects. It also includes genetic counseling to help patients understand their risk and manage their health, unlike standard treatments that may not emphasize early genetic risk identification and counseling.34678

What data supports the effectiveness of the treatment for Lynch Syndrome screening in endometrial and ovarian cancer?

Research shows that using a universal screening protocol for Lynch syndrome in endometrial cancer improves the rates of genetic counseling and testing, which are crucial for identifying patients and their families who may benefit from further surveillance and preventive measures.34689

Who Is on the Research Team?

SF

Sarah Ferguson, MD

Principal Investigator

Princess Margaret Cancer Centre

Are You a Good Fit for This Trial?

This trial is for women aged 18-70 in Canada with endometrial cancer (excluding certain types) diagnosed within the last 6 months. Participants must have tumor tissue available and be able to consent. Their adult first-degree relatives can join if they give consent and live in Canada.

Inclusion Criteria

I was diagnosed with cancer less than 6 months ago.
First-degree Relatives must be willing and able to give informed consent for participation in the study
First-degree Relatives must reside in Canada
See 3 more

Exclusion Criteria

First-degree Relatives must not reside outside of Canada
My cancer is not uterine adenosarcoma, leiomyosarcoma, or endometrial stromal sarcoma.
My ovarian cancer is not purely serous or mucinous.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Genetic Counselling and Testing

Participants at risk for Lynch Syndrome are referred to genetic counselling and undergo genetic testing

4-6 weeks
2 visits (in-person)

Follow-up

Participants found to have Lynch Syndrome are monitored for adherence to screening guidelines and risk-reducing strategies

10 years
Annual updates (virtual or in-person)

Research and Sequencing Studies

Consenting participants provide blood and tumor tissue samples for sequencing studies to investigate genetic basis for Lynch Syndrome

3-5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Educational Material
  • Enhanced Screening Strategy
  • Genetic Counselling
  • Questionnaire
Trial Overview The study tests an enhanced screening strategy for Lynch Syndrome among women with specific cancers, offering genetic counseling and testing. It also evaluates adherence to recommended guidelines over ten years after a Lynch Syndrome diagnosis.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Endometrial and Ovarian Cancer ParticipantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Mount Sinai Hospital, Canada

Collaborator

Trials
210
Recruited
70,700+

Sunnybrook Health Sciences Centre

Collaborator

Trials
693
Recruited
1,569,000+

University of Toronto

Collaborator

Trials
739
Recruited
1,125,000+

Toronto Metropolitan University

Collaborator

Trials
95
Recruited
19,300+

Ryerson University

Collaborator

Trials
77
Recruited
7,800+

Hamilton Health Sciences Corporation

Collaborator

Trials
380
Recruited
345,000+

Citations

Impact of an immunohistochemistry-based universal screening protocol for Lynch syndrome in endometrial cancer on genetic counseling and testing. [2018]
Comparison of two Lynch screening strategies in endometrial cancer in a California health system. [2021]
Lynch Syndrome Screening in the Gynecologic Tract: Current State of the Art. [2022]
Genetic screening in young women diagnosed with endometrial cancer. [2018]
Testing for lynch syndrome in people with endometrial cancer using immunohistochemistry and microsatellite instability-based testing strategies - A systematic review of test accuracy. [2021]
UK colorectal cancer patients are inadequately assessed for Lynch syndrome. [2020]
Implementation of a Systematic Tumor Screening Program for Lynch Syndrome in an Integrated Health Care Setting. [2020]
Current Lynch syndrome tumor screening practices: a survey of genetic counselors. [2022]
Lynch Syndrome: Female Genital Tract Cancer Diagnosis and Screening. [2017]
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