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Genetic Testing

Screening Method for Lynch Syndrome in Endometrial and Ovarian Cancer (LS2 Trial)

N/A
Waitlist Available
Led By Sarah Ferguson, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be 18-70 years old
Patients must have endometrial cancer (all grades, stages and histologic subtypes except stromal sarcoma, carcinosarcoma)
Must not have
Patients must not be under 18 years old or over 70 years old
Patients must not have uterine adenosarcoma, leiomyosarcoma or endometrial stromal sarcoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up short-term assessment at 1 year after diagnosis, long-term assessment for up to 10 years after diagnosis
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new way of identifying women with Lynch Syndrome, a hereditary disease that can lead to cancer. If successful, it could improve screening and surgery options for women at risk.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves questionnaires and educational materials rather than medical treatments, traditional side effects are not expected. However, participants may experience stress or anxiety related to learning about their genetic risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I have endometrial cancer, but it's not stromal sarcoma or carcinosarcoma.
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My cancer tissue is available for a specific protein test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am between 18 and 70 years old.
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My cancer is not uterine adenosarcoma, leiomyosarcoma, or endometrial stromal sarcoma.
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My ovarian cancer is not purely serous or mucinous.
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I cannot or do not want to give informed consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~short-term assessment at 1 year after diagnosis, long-term assessment for up to 10 years after diagnosis
This trial's timeline: 3 weeks for screening, Varies for treatment, and short-term assessment at 1 year after diagnosis, long-term assessment for up to 10 years after diagnosis for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence to screening guidelines (colonoscopy and gynecologic risk-reducing surgery) in participants found to have Lynch Syndrome
Cost-effectiveness of universal enhanced screening strategy to identify women with Lynch Syndrome and their family members via cascade testing
Secondary study objectives
Discovery of novel genetic mutations and molecular events in unexplained MMR loss (Lynch-like Syndrome)
Incidence of Lynch Syndrome in an unselected group of women with endometrial and non-serous ovarian cancer

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Endometrial and Ovarian Cancer ParticipantsExperimental Treatment1 Intervention
All study subjects will be offered the same options for screening and follow-up.

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaOTHER
203 Previous Clinical Trials
68,550 Total Patients Enrolled
Sunnybrook Health Sciences CentreOTHER
673 Previous Clinical Trials
1,564,981 Total Patients Enrolled
University of TorontoOTHER
713 Previous Clinical Trials
1,021,553 Total Patients Enrolled

Media Library

Enhanced Screening Strategy (Genetic Testing) Clinical Trial Eligibility Overview. Trial Name: NCT02494791 — N/A
Lynch Syndrome Research Study Groups: Endometrial and Ovarian Cancer Participants
Lynch Syndrome Clinical Trial 2023: Enhanced Screening Strategy Highlights & Side Effects. Trial Name: NCT02494791 — N/A
Enhanced Screening Strategy (Genetic Testing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02494791 — N/A
~86 spots leftby Oct 2025
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