Study on the Ultrasound and Biological Characteristics of Atypical Endometriosis. (ENDOAT)
Endometriosis "Atypical" and Cancerized: Anatomopathological and Clinical-instrumental Characterization on the Ultrasound and Biological Characteristics of Atypical Endometriosis.
This study hypothesizes that the histological, immunophenotypic, and molecular characterization of atypical endometriotic lesions may be related to specific clinical and ultrasound features.Identifying potentially atypical lesions would allow for more accurate stratification of patients, distinguishing definitely benign from potentially atypical endometriosis.
The targeted study of endometriosis, both typical and atypical, also with reference to the inflammatory microenvironment, as well as immunophenotypic and molecular characteristics, could allow the formulation of pathogenic hypotheses on the development and progression of atypia towards malignant neoplasms.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Observational, retrospective-prospective, cross-sectional, single-center study conducted on patients undergoing laparoscopic surgery for benign or malignant pathology (endometrial or ovarian). The study does not include changes to the standard care pathway and all procedures are in normal clinical practice. The indication for surgical treatment is formulated on the basis of the most up-to-date guidelines on the subject. The study includes two phases:
- Single-center observational retrospective study with case collection starting June 2024
- Single-center prospective observational study with recruitment of new cases for 30 months after the start of the project.
At the time of the pre-hospitalization visit, the patient will be clearly and understandably illustrated with the rationale and objective of the study, the planned procedures (which do not deviate from normal clinical practice) and the data that are intended to be collected for each patient. There are four groups under comparison: patients with endometriosis without atypia and patients with neoplasia not associated with endometriosis represent the "controls", while patients with atypical endometriosis and patients with cancerized endometriosis or neoplasia associated with endometriosis represent the "cases". Patients with ovarian / endometrial neoplasia not associated with endometriosis will serve as a control for both the ultrasound appearance of the lesions and for anatomopathological analysis (including immunohistochemical and molecular investigations).
Patients included in the study will undergo a level II gynecological ultrasound with transvaginal technique by experienced operators, the images will be reviewed by two experienced operators.
Patients will be operated on by operators experienced in endometriosis surgery. The anatomopathological diagnostic report will be structured sec. International Collaboration on Cancer Reporting (ICCR) (Annexes 1 and 2), which includes essential elements ("core"), and optional elements ("non-core") (https://www.iccr-cancer.org/).
Each case will be evaluated individually and then in doubles by two anatomopathologists experienced in gynecological pathology.
The immunohistochemical and molecular panel are routinely performed in patients with atypical endometriosis, cancerized endometriosis, or endometriosis-associated neoplasia and in neoplasms not associated with endometriosis, therefore the performance of these procedures does not deviate from such clinical practice. In patients with endometriosis "typical", a reduced panel will be performed, if deemed necessary by the pathologist, particularly if there are dubious morphological pictures.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Verona
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Peschiera del Garda, Verona, Itália, 37019
- Recrutamento
- Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
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Contato:
- Daniele Mautone, MD
- Número de telefone: +39 0456444193
- E-mail: urc@ospedalepederzoli.it
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Age > 18 years
- Candidate patients for endometriosis surgery with deep endometriosis (intestine, LUS) and/or endometrioma localizations.
- Patients who are candidates for surgery for established or suspected endometrial and/or ovarian neoplasm
- Patients who have performed a level II gynecological ultrasound with an experienced operator in the preoperative process.
- Patients where there is the technical possibility of performing a transvaginal and/or transrectal ultrasound and the patient's willingness to undergo such an investigation.
- Signing of informed consent.
Exclusion Criteria:
- Technical impossibility of performing a transvaginal ultrasound (patient virgo, patient refusal).
- Previous neoplasms
- Patient who does not provide their informed consent.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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prospective observational group
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Single-center prospective observational study with recruitment of new cases for 30 months from the start of the project.
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retrospective observational group
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Single-center observational retrospective study with case collection starting June 2024
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Identification of specific histopathological, immunohistochemical and molecular biology features for definable "atypical", "preneoplastic" or "cancerized-neoplastic" lesions and the surrounding microenvironment
Prazo: through study completion, an average of 1 year
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through study completion, an average of 1 year
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Identification of specific ultrasound features of lesions described in histological examination as "atypical", "preneoplastic", or "cancerized-neoplastic"
Prazo: through study completion, an average of 1 year
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through study completion, an average of 1 year
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 982CET
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