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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Tine Pinxteren, MSc
- Número de telefone: 32 476014843
- E-mail: tine.pinxteren@uantwerpen.be
Locais de estudo
-
-
Antwerp
-
Edegem, Antwerp, Bélgica, 2650
- Recrutamento
- University Hospital of Antwerp (UZA)
-
Contato:
- Wiebren A.A. Tjalma, MD, PhD
- Número de telefone: +32 03 821 32 50
- E-mail: wiebren.tjalma@uza.be
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number and overview of biomarkers associated with the presence of gynecological (pre-)cancers
Prazo: 48 months
|
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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Comparison of the biomarkers in different sample types
Prazo: 48 months
|
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
|
|
Association of biomarkers and presence of postmenopausal bleeding
Prazo: 72 months
|
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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Wiebren A.A. Tjalma, MD, PhD, University Hospital of Antwerp
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Doenças do Sistema Endócrino
- Neoplasias urogenitais
- Neoplasias por local
- Neoplasias
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doenças uterinas
- Doenças Genitais Femininas
- Neoplasias das Glândulas Endócrinas
- Doenças ovarianas
- Doenças anexiais
- Neoplasias Genitais Femininas
- Distúrbios Gonadais
- Neoplasias uterinas
- Doenças vulvares
- Doenças vaginais
- Neoplasias ovarianas
- Neoplasias endometriais
- Neoplasias vulvares
- Neoplasias Vaginais
Outros números de identificação do estudo
- B3002025000175
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .