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Pilot Study Evaluating the Feasibility of Digitalised Cytolological Slides for Telecytology, Before Implementation in Cameroon

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Qué se está recopilando

Colección de datos

Recopilados desde hoy en adelante - Prospectivo
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Quiénes están siendo reclutados

Neoplasias del Cuello Uterino+9

+ Enfermedades Urogenitales

+ Enfermedades del cuello uterino

A partir de 18 años
+6 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Otro

Uso de métodos específicos que no están cubiertos por los modelos estándar para abordar preguntas de investigación únicas.
Observacional
Inicio del estudio: abril de 2022
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity Hospital, Geneva
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 25 de abril de 2022

Fecha en la que se inscribió al primer participante.

The study will take place over four months. The consultation where the clinician undertakes the colposcopy and takes the additional cytological sample will be the only visit necessary for the patient in relation to the study. The investigators will require thirty usable cervical samples from the colposcopy clinic of the Maternity of Geneva. The spatula used to take the smear should be immediately transferred to a 10ml sample pot and the head of the spatula should be snapped off and left inside. The investigators will only accept samples that have followed the aformentioned conditions, and it is expected to recruit more than the 30 participants needed if sampling is insufficient. The samples will be prepared by one of 3 laboratory technicians at the same hospital using the manual Surepath® liquid-based preparation method. This includes cell randomization, pipetting and enrichment of diagnostic cervical cells through centrifugation using a settling chamber to create a cellular slide preparation in a circle of 13 mm diameter. The Pap staining procedure is then applied within the chamber. All thirty glass slides will be scanned and digitalized with a compact portable scanner (Ocus, ®40 by Grundium, Finland). The same laboratory technician who prepared the cervical sample will scan the slide. Ocus ®40 has a 1-slide capacity and permits the acquisition of a whole-slide image as well as robotic microscopy. The scanner features a 12-megapixel image sensor with a 40x objective (numerical aperture: 0.75) and can be connected to a laptop computer over a Wireless Local Area Network (WLAN) connection. To avoid areas being out of focus, the Z-stack modality of acquisition will be used at three focal plane levels with a 1 µ interval. In Europe, Ocus®40 is IVDR certified for diagnostic use. The ease of the manual preparation method and scanning of slides will be assessed by asking the laboratory technician to rate the difficulty from very easy to very difficult on a 5-point rating scale (score 1= very difficult, 5=very easy) for each preparation step. The time taken for the manual preparation and scanning of glass slides will also be measured with a stopwatch and recorded by the technician. Quality characteristics of the thirty digitalized slides will be scored as excellent, good, fair, or poor (based on sharpness and visualization through thick cell clusters) by two cytopathologists reading the slides. The time taken to screen digitized slides will be calculated. In addition, cellularity will be assessed in the preparation area of the glass slide. Under a 40× objective and an eyepiece with a field number of 20, the total number of cells will be computed using the following formula: N=n(acd/amf), where N=total cell count, n=mean cell count of 10 adjacent fields of view along the horizontal diameter in the center of the circle, acd=area of cell deposit and amf=area of microscopic field. The following data will be recorded and stored for each patient * the number between 1-30 that has been given to the patient plus previous cytological diagnosis * the easiness rating for each step of the manual preparation of the slide (lab technician) * The easiness rating for the scanning/digitalization of the slides (lab technician) * the quality rating based on sharpness and visualization through thick cell clusters for each slide (cytopathologists) * the cellularity of each slide (cytopathologists) * the time taken to prepare (lab technician), digitalize (lab technician) and read (cytopathologists) the slides There will be a separate form for the laboratory providers and the cytopathologists. The data from the lab technician and the cytopathologists will be subsequently unified.

Título OficialPilot Study Evaluating the Feasibility of Digitalised Cytolological Slides for Telecytology, Before Implementation in Cameroon
NCT05474404
Patrocinador PrincipalUniversity Hospital, Geneva
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 30 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Otro

Algunos estudios utilizan métodos únicos o combinados que no encajan en categorías estándar. Pueden incluir enfoques observacionales innovadores o diseñarse para preguntas de investigación específicas.


Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Mujer

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Condiciones

Patología

Neoplasias del Cuello UterinoEnfermedades UrogenitalesEnfermedades del cuello uterinoEnfermedades GenitalesEnfermedades Genitales FemeninasEnfermedades Urogenitales Femeninas y Complicaciones del EmbarazoNeoplasias Genitales FemeninasNeoplasiasNeoplasias por SitioNeoplasias UrogenitalesEnfermedades del ÚteroNeoplasias uterinas

Criterios

3 criterios de inclusión requeridos para participar
Women aged > 18 who are undergoing colposcopy at the Geneva University Hospitals (HUG)

Women who are able to give informed consent as documented by signature

Availability of an adequate sample for analysis

3 criterios de exclusión impiden participar
Pregnant women

Women who have had a hysterectomy

Women in whom cytology is indicated at time of colposcopy (independently of this study)

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Objetivos del Estudio

Objetivos del Estudio

Objetivos Primarios

Centros del Estudio

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Este estudio tiene una ubicación

Suspendido

University Hospitals Geneva

Geneva, SwitzerlandAbrir University Hospitals Geneva en Google Maps
Completado1 Centros de Estudio