Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers (MYSSELF)
The goal of the MYSSELF (Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers) study is to investigate which biological markers (i.e., (epi)genetic biomarkers) found in self-collected samples, such as first-void urine and vaginal samples, are linked to the presence of endometrial, ovarian, vulvar, or vaginal (pre-)cancer or to postmenopausal bleeding. Samples collected by clinicians from the cervix or vulva, as well as blood and tissue samples, will be used for comparison. The study will explore whether these markers could help improve earlier and less invasive detection of gynecological cancers in the future.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Gynecological cancers include cancers of the cervix, endometrium, ovaries, vulva, and vagina. Early detection of these cancers is important, because treatment is more effective before the disease has advanced. At the moment, cervical cancer is the only gynecological cancer with a population-based screening program. For the other types (endometrial, ovarian, vulvar, and vaginal cancer), only diagnostic methods are available, but these are often uncomfortable for patients or not sufficiently specific. Hence, this study aims to improve early detection by looking for new biological markers (i.e., (epi)genetic biomarkers) in less-invasive samples that are associated with the presence of gynecological cancers. For this, different sample types are collected from patients with endometrial, ovarian, vulvar, or vaginal (pre-)cancer (n=100/(pre-)cancer) or from individuals with postmenopausal bleeding (n=330). These samples include self-samples collected at home (first-void urine (Colli-Pee 20 mL prefilled with urine conservation medium (UCM)) and vaginal self-sample (Evalyn brush)), clinician-collected cervical/vulvar samples, and blood samples. Only when a tissue sample is already being taken as part of the participant's standard treatment or diagnostic follow-up, it will be used for this study as well. As such, participants do not undergo additional invasive procedures as part of the study. All these samples are collected before any treatment begins (e.g., surgery, chemotherapy, radiotherapy…). For all analyses, current diagnostic results (e.g., dilation & curettage, transvaginal ultrasonography, blood biomarker CA-125, vulvoscopy, echography, imaging (CT, PET, MRI)) and cancer (histology) diagnoses will be used as the final diagnosis. A questionnaire will provide more information about the presence of risk factors and participants' experiences with the self-sampling methods.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Tine Pinxteren, MSc
- Número de teléfono: 32 476014843
- Correo electrónico: tine.pinxteren@uantwerpen.be
Ubicaciones de estudio
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Antwerp
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Edegem, Antwerp, Bélgica, 2650
- Reclutamiento
- University Hospital of Antwerp (UZA)
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Contacto:
- Wiebren A.A. Tjalma, MD, PhD
- Número de teléfono: +32 03 821 32 50
- Correo electrónico: wiebren.tjalma@uza.be
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Individuals having female genital organs, regardless of their gender identity.
- 18 years old or older at the time of signing the informed consent form.
- Diagnosed with either endometrial, ovarian, vulvar, or vaginal cancer irrespective of stage; diagnosed with one of their precursor lesions; or individuals with postmenopausal bleeding.
- Has not started any form of cancer treatment prior to study enrolment.
- Written informed consent must be obtained from each participant.
- The participant is able to understand the information brochure and what the study is about.
Exclusion Criteria:
- Individuals that underwent hysterectomy or ovariectomy.
- Pregnant individuals or 6 weeks post-partum.
- Treatment for endometrial, ovarian, vulvar, or vaginal (pre-)cancer in the last 6 months before participation in the study.
- Participating in another interventional clinical study (where, e.g., a medical device, drug, or vaccine is evaluated) at the same time as participating in this study. Participation in another observational or low-interventional clinical study at the same time is allowed.
- Unable to give informed consent.
- Participants with a history or current evidence of any condition or abnormality that might confound the results of the study, or when it is not in the best interest of the participant to participate, in the opinion of the investigator.
Exclusion criteria related to blood withdrawal:
- The participant has severe anemia.
- The participant received a blood transfusion two weeks before sample collection.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Participants Providing Samples for Biomarker Analysis
Participants will collect one first-void urine sample and one vaginal self-sample at home, the day before or the day of their planned consultation at the hospital or at the hospital itself. During the hospital visit, an additional clinician-collected cervical and/or vulvar sample and a blood sample will be collected for the study. If a tissue sample is already being taken as part of the participant's standard treatment or diagnostic follow-up, it will also be used for this study. Current diagnostic results (e.g., dilation & curettage, transvaginal ultrasonography, blood biomarker CA-125, vulvoscopy, echography, imaging (CT, PET, MRI)) and cancer (histology) diagnoses will be used as the final diagnosis. |
Participants will collect a first-void urine (the initial part of the urine stream) sample with the 20 mL Colli-Pee device prefilled with urine conservation medium (UCM, DNA Genotek, Canada). This sample can be taken at home the day before or the day of the planned consultation at the hospital or at the hospital itself. Participants will collect a vaginal self-sample with the Evalyn Brush (Rovers Medical Devices, The Netherlands) at home the day before or the day of the planned consultation at the hospital or at the hospital itself. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number and overview of biomarkers associated with the presence of gynecological (pre-)cancers
Periodo de tiempo: 48 months
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The primary objective of this study is to determine the feasibility of detecting (epi)genetic biomarkers in participants with (pre-)cancer (endometrial, ovarian, vulvar, or vaginal cancer). This evaluation will be conducted using multiple sample types: self-samples (first-void urine and vaginal samples), clinician-collected cervical/vulvar samples, blood samples, and tissue samples. |
48 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Comparison of the biomarkers in different sample types
Periodo de tiempo: 48 months
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The secondary objective is to compare the presence of biomarkers across different sample types (self-samples (first-void urine and vaginal samples), clinician-collected cervical/vulvar samples, blood samples, and tissue samples). |
48 months
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Association of biomarkers and presence of postmenopausal bleeding
Periodo de tiempo: 72 months
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The third objective is to explore the association of the identified biomarkers with clinical characteristics in individuals with postmenopausal bleeding, a symptom that can arise from a variety of conditions, including but not limited to endometrial cancer. |
72 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Wiebren A.A. Tjalma, MD, PhD, University Hospital of Antwerp
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema endocrino
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades uterinas
- Enfermedades Genitales Femeninas
- Neoplasias de glándulas endocrinas
- Enfermedades Ováricas
- Enfermedades anexiales
- Neoplasias Genitales Femeninas
- Trastornos gonadales
- Neoplasias Uterinas
- Enfermedades Vulvares
- Enfermedades vaginales
- Neoplasias Ováricas
- Neoplasias Endometriales
- Neoplasias Vulvares
- Neoplasias vaginales
Otros números de identificación del estudio
- B3002025000175
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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