Clinical trial · Interventional
Universal Screening for Lynch Syndrome in Women With Endometrial and Non-Serous Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Lynch Syndrome | — | UNRESOLVED | — |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire, Educational Material | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Endometrial and Ovarian Cancer Participants
- description
- All study subjects will be offered the same options for screening and follow-up.
- interventionNames
- Behavioral: Questionnaire, Educational Material
Primary outcomes (2)
- measure
- Adherence to screening guidelines (colonoscopy and gynecologic risk-reducing surgery) in participants found to have Lynch Syndrome
- timeFrame
- short-term assessment at 1 year after diagnosis, long-term assessment for up to 10 years after diagnosis
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria (Patients): * 18-70 years old * endometrial cancer (all grades, stages and histologic subtypes except stromal sarcoma, carcinosarcoma) * cancer diagnosed within 6 months of consent * tumour tissue available for MMR IHC * willing and able to give informed consent for participation in study Exclusion Criteria (Patients): * patients under 18 years old or over 70 years old * patients with uterine adenosarcoma, leiomyosarcoma or endometrial stromal sarcoma * patients with pure serous or pure mucinous ovarian carcinoma * patients unwilling or unable to participate in the informed consent process Inclusion Criteria (First-degree Relatives) * minimum 18 years old * reside in Canada * willing and able to give informed consent for participation in study Exclusion Criteria (First-degree Relatives): * under 18 years old * reside outside of Canada * unwilling or unable to participate in the informed consent process
References
Publications (0)
Data not yet available