Trial · NCT07877779
Protocol for Non-invasive Gynaecological Surveillance in Lynch Syndrome
NCT07877779, Not yet recruiting, University of Edinburgh
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Protocol for Non-invasive Gynaecological Surveillance in Lynch Syndrome. Trials, record NCT07877779. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07877779
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Protocol for Non-invasive Gynaecological Surveillance in Lynch Syndrome
- NCT number
- NCT07877779
- Status
- Not yet recruiting
- Enrollment
- 1,450 participants, estimated
- Lead sponsor
- University of Edinburgh
- Conditions
- Lynch Syndrome
- First posted
- 2026-10-16
- Last updated
- 2026-10-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To define the diagnostic accuracy of non-invasive surveillance approaches for EC detection and assess non-inferiority to standard surveillance using invasive modalities. | 36 months | Non-inferiority of the diagnostic accuracy of non-invasive surveillance approaches for EC detection in individuals with LS compared to standard practice invasive modalities. |
| Secondary | To define diagnostic sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and yield of each screening test. | 36 months | Diagnostic sensitivity, specificity, PPV, NPV, and yield of each screening test. |
| Secondary | To assess the association between screening and clinicopathological features of the tumours, to understand the biology or clinical features of interval cancers missed by screening as well as the impact of screening on tumour stage. | 36 months | Clinicopathological features of interval (detected between screening tests) and incident (detected by screening) EC, including tumour MMR status, tumour location in the endometrium, tumour stage and grade, etc. |
| Secondary | To determine the feasibility, acceptability, and referral outcomes of annual non-invasive surveillance | 36 months | Number and type of follow-up interventions triggered by surveillance. |
| Secondary | To identify barriers to and ways of optimising surveillance compliance, including integration of at-home self-sampling into surveillance protocols. | 36 months | Changes in QoL questionnaires and symptom checklist over time. |
| Secondary | To model the cost-effectiveness of the non-invasive approach and invasive approach. | 36 months | Incremental cost per case detected and QALY gains. |
| Secondary | To validate an extended MSI-Plus panel for EC early detection from uDNA or vsDNA analysis. | 36 months | Diagnostic sensitivity of MSI-Plus enhanced for EC detection from uDNA and vsDNA. |
| Secondary | To develop and validate molecular classifiers for EC using multi-omic data from Ellele samples. This will include assessment of tumour shedding patterns and identification of novel molecular biomarkers predictive of disease (50 participants. | 12 months | Multi-omic molecular classifier for EC detection from Ellele samples (50 participants). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07877779
GET https://conductscience.org/api/trials/v1/NCT07877779/registered