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Preditores de recidiva de cânceres de ovário, peritoneal e trompas de falópio

10 de outubro de 2026 atualizado por: National Cancer Institute (NCI)

Um estudo multi-institucional de avaliação proteômica de câncer epitelial de ovário, câncer peritoneal primário e pacientes com câncer de trompas de falópio em primeira remissão clínica: desenvolvimento de um perfil de impressão digital de proteína de recaída

This study will develop a blood test that can be used to predict a relapse of ovarian, peritoneal, or fallopian tube cancer. The type of testing is called proteomics, or the study of proteins in living cells. The test will identify certain proteins that might represent a pattern, or "fingerprint," indicating increased risk of disease relapse.

Women with Stage III or IV epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that is in remission may be eligible for this study. Candidates are screened with a medical history and physical examination, blood tests, review of pathology report from surgery, and computed tomography (CT) or magnetic resonance imaging (MRI) scans of the abdomen and pelvis (and chest if the cancer spread to the chest).

Participants have a clinic visit every 3 months for a physical examination (including a pelvic examination), blood draw for routine and research tests, and review of how they have been feeling. Every 6 months they have CT scans of the abdomen, pelvis, and possibly the chest. When a patient has been in remission for 4 years, blood draws are done every 6 months and CT scans are done yearly. Patients whose cancer returns (based on a CA-125 blood test, CT scans, or physical examination) end their participation in the study. Patients with an abnormal CT scan or physical examination may be asked to undergo a tumor biopsy (surgical removal of a piece of tumor tissue) for research purposes.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

Background:

Over 80% of patients with advanced stage epithelial ovarian cancer will relapse

Serum biomarkers are needed for predictors of persistent disease and relapse

CA-125 is a less than satisfactory clinical tool for detecting relapse

A serum repository of samples from women with ovarian cancer is needed to develop and validate the multiple tests being created for ovarian cancer recurrence and screening.

Objectives:

To create a multi-institutional repository from which investigations of serum proteomic signature profiles of epithelial ovarian cancer and relapse will be developed and validated

To determine the sensitivity and specificity of the proteomic signature profiles for relapse

To compare the accuracy of proteomic evaluation and CA125 in classifying patient disease progression

To identify the temporal relationship between a rise in CA125 value versus the development of proteomic signature profiles of relapse.

To detect the impact of study participation on quality of life.

To collect epidemiological data for patients in the target population

Eligibility:

Patients in first remission from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma as defined by normal CA125, no evidence of disease on abdominopelvic CT scan, and normal post-hysterectomy physical exam.

Entry within 12 weeks of last administration of chemotherapy.

S/P surgical debulking and completion of primary therapy with platinum/taxane-containing chemotherapy of no more than a total of 8 cycles.

Laboratory evidence of good end organ function.

Design:

Phase of Trial: Biomarker/Laboratory Analysis.

Number of patients to be enrolled: 400

Planned statistical analysis for primary endpoint: Training set to include 100 women, half of whom are in remission and half of whom have recurrent disease. Validation set will include 200 women, half of whom are in remission and half of whom have recurrent disease.

Tipo de estudo

Observacional

Inscrição (Real)

119

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.

Locais de estudo

  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, Estados Unidos, 90048-1804
        • Cedars Sinai Medical Center
    • Illinois
      • Evanston, Illinois, Estados Unidos
        • Evanston Northwestern University Hospital
    • Maryland
      • Bethesda, Maryland, Estados Unidos, 20892
        • National Institutes of Health Clinical Center
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Massachusetts General Hospital, Dana Farber
    • New York
      • New York, New York, Estados Unidos, 10016
        • New York University School of Medicine
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
        • Duke University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19111
        • Fox Chase Cancer Center
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • University of Texas MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, Estados Unidos, 28104
        • University of Washington/Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Estados Unidos
        • Pacific Ovarian Cancer Research Consortium at FHCRC

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 in first remission from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma as defined by normal CA125, no evidence of disease on abdominopelvic CT scan, and normal post-hysterectomy physical exam.

Descrição

  • INCLUSION CRITERIA:

2.1.1<TAB>All patients in first complete response from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma as defined by: normal CA-125, normal post-hysterectomy physical exam, no evidence of disease on abdominopelvic CT scan (or other noninvasive reassessment, e.g. MRI). PET scans are not acceptable for confirmation of complete response.

2.1.2<TAB>Pathology of the primary tumor must be confirmed by the registering center prior to protocol entry.

2.1.3<TAB>Entry within 9 weeks of completion of final cycle of chemotherapy (within 12 weeks of last administration of chemotherapy).

2.1.4<TAB>S/P surgical debulking and completion of primary therapy with platinum/taxane -containing chemotherapy of no more than 8 total cycles.

2.1.5<TAB>Patients who undergo second look laparotomy or laparoscopy and have microscopic residual disease but who elect not to have treatment will be eligible to enroll.

2.1.6<TAB>Histology slides adequate to confirm the pathology and staging must be submitted to the coordinating center within 3 months of enrollment. (If available, a sample of frozen primary tumor should also be forwarded).

2.1.7<TAB>Patients must be able and willing to provide informed consent to participate in the trial.

2.1.8<TAB>Patients must have laboratory evidence of good end organ function by criteria in Table 1 below. The upper limit of normal is based upon each registering center's laboratory normal ranges.

Laboratory based inclusion criteria:

Laboratory Test: AST(SGOT) and ALT(SGPT)

Required value: less than or equal to 2.5 times the institutional upper limit of normal creatinine

OR

Laboratory Test: Creatinine

Required value: Less than or equal to 2.0

Laboratory Test: Creatinine clearance

Required Value: Greater than or equal to 45 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal.

EXCLUSION CRITERIA:

2.2.1<TAB>Patients with nonepithelial ovarian cancer, mixed epithelial/nonepithelial ovarian cancer (i.e., Mixed Malignant Mullerian Tumors), or tumors of low malignant potential. Patients with stage I or II epithelial ovarian, fallopian tube, or primary peritoneal cancer.

2.2.2<TAB>Patients may not be receiving chemotherapy (therapeutic or consolidation), maintenance, alternative therapy, or radiation therapy. No anti-cancer therapy of any kind is allowed while the patient is on-study. Replacement hormonal therapy is allowed but must be clearly indicated on the case report forms submitted. Hormonal anti-cancer therapies such as tamoxifen and raloxifene will not be permitted while on study.

2.2.3<TAB>Patients with a life expectancy of less than 6 months for any reason.

2.2.4 <TAB>Patients with a history of other invasive malignancies within the past five years prior to enrollment except for curatively treated carcinoma in situ of the cervix, ductal or lobular carcinoma in situ of the breast, concomitant stage I endometrial cancer, or basal or squamous cell skin cancers.

2.2.5 <TAB>Complementary and alternative agent use is discouraged on this study due to the possibility that the use of these agents may alter the serum protein pattern. The Institutional Principal Investigator will have discretion as to whether complementary or alternative agent usage will prevent eligibility on a case by case basis.

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: CASE_ONLY
  • Perspectivas de Tempo: PROSPECTIVE

Coortes e Intervenções

Grupo / Coorte
patients

Patients in first remission from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Create a multi-institutional repository from which investigations of serum proteomic signature profiles of epithelial ovarian cancer and relapse will be developed and validated
Prazo: End of specimen collection

Multi-institutional repository from which investigations of serum proteomic signature profiles of epithelial ovarian cancer and relapse will be developed and validated
End of specimen collection

Colaboradores e Investigadores

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

Patrocinador

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Elise C Kohn, M.D., National Cancer Institute (NCI)

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.

Publicações Gerais

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)

12 de dezembro de 2005

Datas de inscrição no estudo

Enviado pela primeira vez

2 de julho de 2004

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de julho de 2004

Primeira postagem (Estimado)

5 de julho de 2004

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de outubro de 2026

Última verificação

6 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 040232
  • 04-C-0232

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

Prazo de Compartilhamento de IPD

Clinical data are available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.

Critérios de acesso de compartilhamento IPD

Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

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

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