Who is sponsoring NCT04312737?

NCT04312737 is sponsored by Hiantis Srl.

What drugs are being tested in NCT04312737?

Interventions in NCT04312737: Self-Collecting Devices, In Vitro Diagnostic Assays.

What condition does NCT04312737 study?

NCT04312737 studies Cervical Intraepithelial Neoplasia Grade 2/3, Neoplasm Cervix, Carcinoma in Situ, Carcinoma Cervix Uterine, Neoplasms, Neoplasms by Histologic Type.

Is NCT04312737 still recruiting?

NCT04312737 is currently completed. Last updated 6 January 2023.

Last reviewed 2023-01-06 · How we verify

NCT04312737: EU-VALHUDES

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of in Vitro Devices on Self-collected Vaginal Swab and Urine Sample for Testing of Human Papilloma Virus

Completed Last updated 6 January 2023

What this trial tests

trial testing Self-Collecting Devices in Cervical Intraepithelial Neoplasia Grade 2/3 in 600 participants. Completed in 15 March 2022.

Timeline

16 July 2020

Primary endpoint
23 February 2022

15 March 2022

Quick facts

Lead sponsor	Hiantis Srl
Status	Completed
Study type	OBSERVATIONAL
Enrollment	600
Start date	16 July 2020
Primary completion	23 February 2022
Estimated completion	15 March 2022
Sites	6 locations across Italy, Ireland, United Kingdom

Drugs / interventions tested

Self-Collecting Devices
In Vitro Diagnostic Assays

Conditions studied

Cervical Intraepithelial Neoplasia Grade 2/3 — all drugs for Cervical Intraepithelial Neoplasia Grade 2/3 →
Neoplasm Cervix — all drugs for Neoplasm Cervix →
Carcinoma in Situ — all drugs for Carcinoma in Situ →
Carcinoma Cervix Uterine — all drugs for Carcinoma Cervix Uterine →

Sponsor

Hiantis Srl

Who can join

Adults 25 to 65, female only, with Cervical Intraepithelial Neoplasia Grade 2/3 or Neoplasm Cervix. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The European VALHUDES study is a Clinical Performance /Diagnostic Test Accuracy Study that aims to evaluate whether HPV testing with new assays performed on self-samples, collected by means of a vaginal and a urine collection device is as accurate to detect cervical pre-cancer as on cliniciantaken cervical samples.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Clinical Performance of OncoPredict HPV Screening Assay on Self-Collected Vaginal and Urine Specimens Within the VALHUDES Framework.
Giubbi C, Martinelli M, Latsuzbaia A, Cuschieri K, et al · · 2024 · cited 6× · PMID 39588720 · DOI 10.1002/jmv.70079

Verify or expand the search:

Other recruiting trials for Cervical Intraepithelial Neoplasia Grade 2/3

Currently open trials in the same condition.

NCT03064087 — Validation of Human Papillomavirus Assays and Collection Devices for Self-samples and Urine Samples · active not recruiting

Other Hiantis Srl trials

Trials by the same sponsor.

NCT05193669 — Clinical Validation of Molecular Triage in HR-HPV Positive Women · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04312737 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hiantis Srl
Last refreshed: 6 January 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/NCT04312737.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing