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Alavancando marcadores de DNA metilado (MDMs) na detecção de câncer de endométrio, câncer de ovário e câncer cervical (ECHO)

4 de novembro de 2026 atualizado por: Mayo Clinic

Alavancando marcadores de DNA metilado (MDMs) na detecção de câncer de endométrio, câncer de ovário e câncer cervical: um estudo clínico de fase II

The overarching objective of this project is to develop a pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and/or plasma.

This proposal defines Phase II MDM-based cancer detection studies in endometrial cancer (EC) and endometrial hyperplasia with atypia (AEH) in vaginal fluid and 2) ovarian cancer (OC) in plasma and vaginal fluid. Additionally, it defines necessary Phase I MDM-based cancer detection and exploratory aims to test novel cervical cancer (CC) MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.er detection and exploratory aims to test novel cervical cancer MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

Detection of endometrial, ovarian, and cervical cancers at an early stage vastly increases the chances of cure and may also avert morbidity secondary to surgical staging, radiation, and/or chemotherapy. Despite the great successes of cervical cancer screening, comparable early detection methods for other gynecologic cancers and their precursors are not available. While nearly 1.5 million women per year in the United States are evaluated for abnormal uterine bleeding (AUB) or postmenopausal bleeding (PMB), the most common symptom of endometrial cancer, most undergo an invasive diagnostic biopsy with the finding of benign etiology.

Vaginal bleeding is often the only presenting symptom of women ultimately diagnosed with endometrial cancer (EC) or its precursor lesion, endometrial hyperplasia(EH). More than 90% of women with EC present with vaginal bleeding. Cervical cancer and cervical dysplasia can present as intermenstrual bleeding, post-coital bleeding, or other abnormal vaginal bleeding. However, most women who present with AUB or PMB have a benign etiology.

There are approximately 70 million women ≥45 years of age in the United States based on the most recent census data. Between 4-11% of women will be worked up for perimenopausal AUB or PMB in their lifetime. As only 5-10% of those women will have an EC or EH, there is a great clinical need for a less invasive clinical diagnostic test that can reliably distinguish between benign uterine bleeding and bleeding associated with an underlying endometrial cancer, cervical cancer, or a precursor lesion.

Tipo de estudo

Observacional

Inscrição (Estimado)

3110

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85054
        • Recrutamento
        • Mayo Clinic
        • Investigador principal:
          • Kristina A. Butler, M.D.
        • Contato:
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32224
        • Recrutamento
        • Mayo Clinic
        • Contato:
        • Investigador principal:
          • Tri A. Dinh, M.D.
      • Miami, Florida, Estados Unidos, 33173
        • Recrutamento
        • Genoma Research, Inc.
        • Contato:
        • Investigador principal:
          • Guillermo Lievano, D.O.
        • Subinvestigador:
          • Itsel Cardenas, PhD, APRN
      • Miami, Florida, Estados Unidos, 33156
        • Ativo, não recrutando
        • My GYN Care
      • Orlando, Florida, Estados Unidos, 32806
      • Pembroke Pines, Florida, Estados Unidos, 33029
        • Ativo, não recrutando
        • Signature Women's Healthcare, LLC
      • Sarasota, Florida, Estados Unidos, 34239
        • Recrutamento
        • Sarasota Memorial Health Care System
        • Investigador principal:
          • Toni P Kilts, D.O.
        • Contato:
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30318
        • Recrutamento
        • Piedmont Healthcare
        • Contato:
        • Investigador principal:
          • Leda Portia A. Gattoc, M.D.
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
      • Evergreen Park, Illinois, Estados Unidos, 60805
        • Ativo, não recrutando
        • Providea Health Partners, LLC
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70121
        • Recrutamento
        • Ochsner Clinic Foundation
        • Investigador principal:
          • Diogo Torres, M.D.
        • Contato:
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48202
        • Recrutamento
        • Henry Ford Health
        • Contato:
        • Contato:
        • Investigador principal:
          • Ilinca Lupea, M.D.
      • Saginaw, Michigan, Estados Unidos, 48602
        • Recrutamento
        • Valley OB-GYN Clinic
        • Contato:
        • Investigador principal:
          • Olivia A. Phifer-Combs, M.D.
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Recrutamento
        • Mayo Clinic
        • Contato:
        • Investigador principal:
          • Jamie N. Bakkum-Gamez, MD
    • Mississippi
      • Jackson, Mississippi, Estados Unidos, 39213
        • Recrutamento
        • University of Mississippi Medical Center
        • Investigador principal:
          • Rodney Rocconi, M.D.
        • Contato:
        • Contato:
    • New York
      • Howard Beach, New York, Estados Unidos, 11414
        • Recrutamento
        • The Woman's Health Pavilion
        • Contato:
        • Investigador principal:
          • Andre H. Saad, M.D.
      • Westbury, New York, Estados Unidos, 11590
        • Recrutamento
        • The Woman's Health Pavilion
        • Contato:
        • Investigador principal:
          • Andre H. Saad, M.D.
    • North Dakota
      • Grand Forks, North Dakota, Estados Unidos, 58206
        • Recrutamento
        • Altru Health System
        • Investigador principal:
          • Collette Lessard, M.D.
        • Contato:
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
        • Recrutamento
        • Cleveland Clinic Foundation
        • Contato:
        • Contato:
        • Investigador principal:
          • Michelle L. Kuznicki, M.D.
    • Texas
      • Houston, Texas, Estados Unidos, 77018
        • Recrutamento
        • Total Women's Care of the Heights
        • Investigador principal:
          • Vonne Jones, M.D.
        • Contato:
      • Katy, Texas, Estados Unidos, 77450
        • Recrutamento
        • Medical Colleagues of Texas, LLP
        • Contato:
        • Investigador principal:
          • Kelly A. McCullagh, M.D.
    • Virginia
      • Richmond, Virginia, Estados Unidos, 23219
        • Recrutamento
        • Virginia Commonwealth University/ Massey Cancer Center
        • Investigador principal:
          • Chelsea Salyer, M.D.
        • Contato:
        • Contato:
          • Morgan DeHart, CRC
          • Número de telefone: 804-827-1266
          • E-mail: dehart2@vcu.edu
    • Wisconsin
      • Eau Claire, Wisconsin, Estados Unidos, 54703
        • Recrutamento
        • Mayo Clinic Health System - Northwest Wisconsin
        • Contato:
        • Contato:
        • Investigador principal:
          • Blenda Yun, M.D.
      • La Crosse, Wisconsin, Estados Unidos, 54601
        • Recrutamento
        • Mayo Clinic Health System - Southwest Wisconsin
        • Contato:
        • Contato:
        • Investigador principal:
          • Rebecca A. Scarseth, D.O.
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Ativo, não recrutando
        • Medical College of Wisconsin

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients presenting to a GYN or GYN Surgery Clinic for evaluation of symptoms or for consultation and planned procedures as outlined in the seven study cohort descriptions.

Descrição

Inclusion Criteria for Cohort 1:

Patients will be ≥45 years of age and meet one of the following criteria:

  • Abnormal uterine bleeding
  • Postmenopausal bleeding

OR

Patients ages 18 - 44 years of age and meet these criteria

  • Abnormal uterine bleeding
  • One risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use)

Exclusion Criteria for Cohort 1:

  • Prior hysterectomy
  • Current known pregnancy diagnosis
  • Any prior pelvic or vaginal radiotherapy
  • Any prior cancer (except basal cell skin cancer) within the past 5 years
  • Chemotherapy within the past 5 years
  • Current biopsy-proven cervical, vaginal, or vulvar cancer or lower genital tract dysplasia
  • Current biopsy-proven endometrial cancer or endometrial hyperplasia
  • Current biopsy-proven benign endometrial polyp
  • Endometrial biopsy/sampling within the preceding 1 month showing benign endometrium

Inclusion Criteria for Cohort 2:

Patients will be ≥18 years of age and meet at least one of the following criteria:

  • Presence of biopsy-proven EC (any histology, including uterine carcinosarcoma) and surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D&C, hysteroscopic resection
  • Biopsy showing AEH or EIN with surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D&C, hysteroscopic resection, etc)

Exclusion Criteria for Cohort 2:

  • Undergoing surgical procedure for recurrent or metastatic EC
  • Received preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis
  • Prior hysterectomy
  • Current known pregnancy diagnosis
  • Prior or current biopsy-proven cervical cancer
  • Presence of concomitant biopsy-proven cervical dysplasia
  • Any prior pelvic or vaginal radiotherapy
  • Any prior cancer (except basal cell skin cancer) within the past 5 years
  • Chemotherapy within the past 5 years
  • Prior intervention or surgery with intent to completely remove the target pathology

Inclusion Criteria for Cohort 3:

Patients will be ≥18 years of age, have a cervix and meet at least one of the following criteria:

  • History of current abnormal cervical/endocervical Pap test for which the patient is presenting for colposcopy
  • Cervical mass identified on physical exam and patient referred for cervical biopsy, even if colposcopy not recommended or indicated
  • Planned clinically indicated surgical excisional biopsy or removal of the cervix (cold knife cone, LEEP, hysterectomy) for abnormal Pap test, cervical dysplasia, cervical mass, or biopsy-proven invasive cervical cancer (adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or less common primary cervical carcinomas all eligible)

Exclusion Criteria for Cohort 3:

  • History of pelvic or vaginal radiotherapy
  • Prior total hysterectomy (cervix removed) for any indication
  • Current known pregnancy diagnosis
  • Cervical mass biopsy-proven to be EC or a cancer metastatic from a non-cervical origin
  • Any prior cancer (except basal cell skin cancer) within the past 5 years
  • Chemotherapy within the past 5 years
  • Patients presenting for colposcopy as part of lower genital tract dysplasia or cancer surveillance after prior curative intent treatment and no current Pap abnormality or cervical mass
  • Prior intervention or surgery with intent to completely remove the target pathology for the current lesion / diagnosis during the current episode

Inclusion Criteria for Cohort 4:

Patients will be ≥45 years of age and should meet at least one of the following criteria:

  • Undergoing hysterectomy with biopsy-proven or clinically presumed (based on imaging and/or clinical symptoms) benign gynecologic or uterine pathology of fibroids, endometriosis, adenomyosis, or benign endometrial polyps.
  • Undergoing any gynecologic surgery in which a benign pathologic tissue diagnosis of fibroids, endometriosis, adenomyosis, or benign endometrial polyp is anticipated to be confirmed.

Exclusion Criteria for Cohort 4:

  • Endometrial biopsy or office hysteroscopy within 2 weeks preceding the planned gynecologic surgery procedure for fibroids, endometriosis, benign endometrial polyps, or adenomyosis
  • Any surgery within the past 3 months
  • Prior hysterectomy
  • Current known pregnancy diagnosis
  • Prior or current biopsy-proven gynecologic cancer
  • Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia
  • Prior pelvic or vaginal radiotherapy
  • Any prior cancer (except basal cell skin cancer) within the past 5 years
  • Chemotherapy within the past 5 years
  • Undergoing hysterectomy for prolapse without a coexisting known or presumed benign uterine pathologic diagnosis of fibroids, endometriosis, benign endometrial polyps, or adenomyosis
  • Prior intervention or surgery with intent to completely remove the target pathology for the current lesion / diagnosis during the current episode

Inclusion Criteria for Cohort 5:

Patients with a uterus will be ≥45 years of age and should meet the following criteria:

  • Presenting for GYN wellness exam, ± Pap test
  • No change in medical conditions, new diagnoses, or new medications within the past 6 months

Exclusion Criteria for Cohort 5:

  • Pap test or cervical biopsy within the past 1 month
  • Endometrial biopsy or office hysteroscopy within the past 1 month
  • Any surgery within the past 3 months
  • Prior hysterectomy
  • Current known pregnancy diagnosis
  • Prior or current biopsy-proven gynecologic cancer
  • Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia
  • Prior pelvic or vaginal radiotherapy
  • Any prior cancer (except basal cell skin cancer) within the past 5 years
  • Chemotherapy within the past 5 years
  • Criteria met for inclusion in any of the other study cohorts

Inclusion Criteria for Cohort 6:

Patients ≥50 years of age and:

  • Postmenopausal
  • At least 1 intact ovary
  • Diagnosis of an adnexal mass or a clinical suspicion of early-stage ovarian cancer (including fallopian tube cancer)
  • Planned surgery for the adnexal mass
  • For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube* (without prior tubal ligation/occlusion)

Exclusion criteria for Cohort 6:

  • Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn)
  • Chemotherapy for cancer treatment within the past 5 years prior to collection
  • Clinically suspected advanced stage ovarian cancer (Stage III or IV) on presentation, if known prior to specimen collection
  • Surgical candidates for recurrent ovarian cancer
  • History of pelvic or vaginal radiation therapy
  • Known current synchronous endometrial cancer or hyperplasia
  • Known current cervical, vaginal, or vulvar dysplasia

Inclusion criteria for Cohort 7:

Women will be ≥18 years of age and meet the following criteria:

  • Presence of clinically probable ovarian, fallopian tube, or primary peritoneal cancer (all under the umbrella of OC) based on clinical findings of any/all of the following: imaging showing adnexal and/or abdominal masses consistent with probable ovarian cancer, omental caking, elevated CA125, ascites, imaging-guided biopsy consistent with OC pathology
  • Newly diagnosed with ovarian, fallopian tube or primary peritoneal cancer without neoadjuvant therapy
  • At least one intact ovary
  • For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube* (without prior tubal ligation/occlusion)

Exclusion criteria for Cohort 7:

  • Patients with recurrent OC
  • Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years
  • Chemotherapy for cancer treatment within the past 5 years prior to collection
  • History of pelvic or vaginal radiation therapy
  • Known current synchronous endometrial cancer or hyperplasia
  • Known current cervical, vaginal, or vulvar dysplasia
  • Current known pregnancy diagnosis

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Modelos de observação: COHORT
  • Perspectivas de Tempo: PROSPECTIVE

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Cohort 1 - AUB / PMB

Patients ≥45 years of age, presenting with abnormal uterine bleeding (AUB) or post-menopausal bleeding (PMB). Patients ages 18 - 44 years of age, presenting with abnormal uterine bleeding (AUB) and a risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use). These presenting symptoms clinically warrant evaluation such as an endometrial biopsy to assess for underlying endometrial cancer, endometrial hyperplasia or other endometrial pathology.
Teste de diagnostico: Vaginal Fluid Collection

A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.

Outros nomes:
  • Fluido vaginal
Teste de diagnostico: Blood Collection

A blood sample will be collected from each participant prior to undergoing any exams or procedures.
Cohort 2 - Biopsy-proven EC or AEH or EIN

Patients ≥18 years of age with biopsy-proven endometrial cancer (EC), atypical endometrial hyperplasia (AEH), or endometrial intraepithelial neoplasia (EIN) presenting for surgical management of their endometrial pathology.
Teste de diagnostico: Vaginal Fluid Collection

A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.

Outros nomes:
  • Fluido vaginal
Teste de diagnostico: Blood Collection

A blood sample will be collected from each participant prior to undergoing any exams or procedures.
Cohort 3 - Cervix pathology

Patients ≥18 years of age presenting for a clinically indicated colposcopy, cervical biopsy, or surgical excision, as follow-up for an abnormal Pap test or cervical mass identified on physical exam. Final clinical diagnoses within this cohort may include mild cervical intraepithelial neoplasia (CIN 1), moderate and/or severe CIN (CIN 2/3), adenocarcinoma in situ (AIS), invasive cervical cancers (adenocarcinoma or squamous cell carcinoma), or possibly benign findings.
Teste de diagnostico: Vaginal Fluid Collection

A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.

Outros nomes:
  • Fluido vaginal
Teste de diagnostico: Blood Collection

A blood sample will be collected from each participant prior to undergoing any exams or procedures.
Cohort 4 - Benign Uterine Pathology

Patients with any of four benign gynecologic conditions including: uterine fibroids, benign endometrial polyps, adenomyosis and endometriosis. All patients enrolled in this cohort will be undergoing clinically indicated gynecologic surgery (hysterectomy, myomectomy, polypectomy, or laparoscopic tissue excision) for the specific benign gynecologic condition. Verification of the final benign diagnosis will be based on pathology diagnosis of clinically-indicated tissue removed during surgery.
Teste de diagnostico: Vaginal Fluid Collection

A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.

Outros nomes:
  • Fluido vaginal
Teste de diagnostico: Blood Collection

A blood sample will be collected from each participant prior to undergoing any exams or procedures.
Cohort 5 - Healthy Control Women

Healthy patients with a uterus, ≥45 years of age presenting for GYN wellness exam to serve as a control group. These patients will have no clinically evident gynecologic precancers, gynecologic cancers, or clinically evident or symptomatic benign gynecologic conditions. These patients will not have known or clinically suspected AUB, PMB, fibroids, endometriosis, benign endometrial polyps, or adenomyosis, nor will they have any active gynecologic or non-gynecologic acute medical conditions.
Teste de diagnostico: Vaginal Fluid Collection

A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.

Outros nomes:
  • Fluido vaginal
Teste de diagnostico: Blood Collection

A blood sample will be collected from each participant prior to undergoing any exams or procedures.
Cohort 6- Isolated Adnexal Mass Cohort (ovarian or fallopian mass)

Patients ≥50 years of age and postmenopausal (12 months since LMP or available blood hormone levels confirming postmenopausal status) and an isolated adnexal mass or isolated bilateral adnexal masses being surgically removed. These patients may have a final diagnosis of any of the following: benign ovarian neoplasm, borderline tumor of the ovary, or clinically early-stage OC.
Teste de diagnostico: Vaginal Fluid Collection

A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.

Outros nomes:
  • Fluido vaginal
Teste de diagnostico: Blood Collection

A blood sample will be collected from each participant prior to undergoing any exams or procedures.
Cohort 7 - OC Cohort - Biopsy proven or clinically suspected ovarian cancer (OC)

Patients ≥18 years of age with ovarian cancer (OC) (clinically probable based on distribution of pelvic/abdominal masses on imaging, elevated CA-125, ascites, and/or imaging-guided biopsy proven) presenting for neoadjuvant chemotherapy or primary surgical management (debulking or staging) of their OC. The umbrella of OC also includes fallopian tube cancer and primary peritoneal cancer. All histologies are eligible for enrollment.
Teste de diagnostico: Vaginal Fluid Collection

A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.

Outros nomes:
  • Fluido vaginal
Teste de diagnostico: Blood Collection

A blood sample will be collected from each participant prior to undergoing any exams or procedures.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Develop predictive models from a panel of EC-specific MDMs and validate their performance in identifying underlying EC and AEH within vaginal fluid in a larger, more diverse cohort.
Prazo: 18 months

Complete a phase II biomarker development study of a methylated DNA marker (MDM)-based endometrial cancer detection test performed on vaginal fluid. The phase II aspect of this biomarker development study will narrow the number of endometrial cancer MDMs within the biomarker panel in order to optimize the next phase of test development.
18 months
Develop predictive models from a panel of OC-specific MDMs and validate their performance in identifying underlying OC within vaginal fluid and plasma in a larger, more diverse cohort.
Prazo: 18 months

Complete a phase II biomarker development study of a methylated DNA marker (MDM)-based ovarian cancer detection test performed on vaginal fluid. The phase II aspect of this biomarker development study will narrow the number of ovarian cancer MDMs within the biomarker panel in order to optimize the next phase of test development.
18 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Using 95% specificity cutoffs of the final MDM EC panel, determine the false positive rate among women undergoing surgical removal of common benign gynecologic pathology
Prazo: 18 months

As part of this biomarker test development, understanding whether common non-cancerous uterine or gynecologic conditions may also lead to the finding of currently apparent endometrial cancer-specific MDMs in vaginal fluid is critical in determining specificity, positive predictive value, and negative predictive value of the test.
18 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Mayo Clinic

Investigadores

  • Investigador principal: Jamie N. Bakkum-Gamez, M.D., Mayo Clinic

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

3 de agosto de 2021

Conclusão Primária (Estimado)

30 de julho de 2027

Conclusão do estudo (Estimado)

30 de setembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

11 de setembro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de setembro de 2021

Primeira postagem (Real)

21 de setembro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 20-012833

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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 .

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