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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)
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
LS2 Trial 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.Check my eligibility
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.See study design
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.
LS2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
Select...
I have endometrial cancer, but it's not stromal sarcoma or carcinosarcoma.
Select...
My cancer tissue is available for a specific protein test.
LS2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ short-term assessment at 1 year after diagnosis, long-term assessment for up to 10 years after diagnosis
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
LS2 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?
Sunnybrook Health Sciences CentreOTHER
656 Previous Clinical Trials
1,549,736 Total Patients Enrolled
University of TorontoOTHER
689 Previous Clinical Trials
1,017,757 Total Patients Enrolled
Mount Sinai Hospital, CanadaOTHER
196 Previous Clinical Trials
66,722 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 70 years old.I am between 18 and 70 years old.My cancer is not uterine adenosarcoma, leiomyosarcoma, or endometrial stromal sarcoma.My ovarian cancer is not purely serous or mucinous.I was diagnosed with cancer less than 6 months ago.My first-degree relatives are at least 18 years old.I cannot or do not want to give informed consent.I have endometrial cancer, but it's not stromal sarcoma or carcinosarcoma.My cancer tissue is available for a specific protein test.All my first-degree relatives are 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Endometrial and Ovarian Cancer Participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still open for this research project?
"This trial, which was initially posted on July 1st 2015 and last updated 16th May 2022, is no longer accepting patients. Nevertheless, there are 5139 other medical studies currently seeking participants."
Answered by AI
Are individuals aged 35 years or older being included in this research?
"This medical trial is seeking participants aged 18 and upwards, with a maximum age of 70."
Answered by AI
What types of individuals would be most suitable for this research initiative?
"Researchers are looking for 886 individuals with lynch syndrome who range from 18 to 70 years old, and possess tumour tissue available for MMR IHC."
Answered by AI
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