Screening Method for Lynch Syndrome in Endometrial and Ovarian Cancer

(LS2 Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Uterine adenosarcoma, Leiomyosarcoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

886 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{1 2 3 4 9}

Research Team

Sarah Ferguson, MD

Principal Investigator

Princess Margaret Cancer Centre

Eligibility Criteria

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 am between 18 and 70 years old.

I was diagnosed with cancer less than 6 months ago.

My first-degree relatives are at least 18 years old.

Exclusion Criteria

First-degree Relatives must not reside outside of Canada

I am between 18 and 70 years old.

My cancer is not uterine adenosarcoma, leiomyosarcoma, or endometrial stromal sarcoma.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Endometrial and Ovarian Cancer Participants Experimental Treatment 1 Intervention

All study subjects will be offered the same options for screening and follow-up.

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of an immunohistochemistry-based universal screening protocol for Lynch syndrome in endometrial cancer on genetic counseling and testing. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of two Lynch screening strategies in endometrial cancer in a California health system. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Lynch Syndrome Screening in the Gynecologic Tract: Current State of the Art. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Genetic screening in young women diagnosed with endometrial cancer. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Testing for lynch syndrome in people with endometrial cancer using immunohistochemistry and microsatellite instability-based testing strategies - A systematic review of test accuracy. [2021]

6. England pubmed.ncbi.nlm.nih.gov

UK colorectal cancer patients are inadequately assessed for Lynch syndrome. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Implementation of a Systematic Tumor Screening Program for Lynch Syndrome in an Integrated Health Care Setting. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Current Lynch syndrome tumor screening practices: a survey of genetic counselors. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Lynch Syndrome: Female Genital Tract Cancer Diagnosis and Screening. [2017]