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NCT04952961
Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study
NA trial testing Training in Vulval Self-Examination in Self-Examination in 25 participants. Completed in 6 March 2023.
30 July 2022
Quick facts
| Lead sponsor | University of Manchester |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 25 |
| Start date | 4 November 2021 |
| Primary completion | 30 July 2022 |
| Estimated completion | 6 March 2023 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Training in Vulval Self-Examination
Conditions studied
- Self-Examination — all drugs for Self-Examination →
- Vulvar Cancer — all drugs for Vulvar Cancer →
- Vulvar Lichen Sclerosus — all drugs for Vulvar Lichen Sclerosus →
- Vulval Intraepithelial Neoplasia — all drugs for Vulval Intraepithelial Neoplasia →
Sponsor
University of Manchester
Who can join
18 and older, female only, with Self-Examination or Vulvar Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Vulval cancer, while rare, has increased in incidence by 17% since the 1990s. It is strongly associated with age, thus this increasing trend is likely to continue with extended life expectancy. Vulval cancer is highly treatable when detected early. Women with chronic vulval conditions including lichen sclerosus, lichen planus and vulval intraepithelial neoplasia are at increased risk of developing vulval cancer. Most patients are in hospital follow-up, however regular vulval self-examination can pick up lesions earlier. There are no formalised methods of teaching self-examination and no evidence that it is acceptable to women. The main objective of this study is to pilot an intervention to promote and support vulval self-examination for women at increased risk of vulval cancer including those with lichen sclerosus, lichen planus and vulval intraepithelial neoplasia. Findings from this feasibility study will inform the design of a randomised trial comparing the interventions versus control with an embedded cost-effectiveness analysis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04952961
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04952961 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Manchester
- Last refreshed: 22 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04952961.
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