Development of in vitro diagnostic multivariate index assay using liquid-based cervical cytology specimen and/or serum/plasma biomarkers for the detection of early stage or low-volume ovarian cancer

使用液基宫颈细胞学标本和/或血清/血浆生物标志物开发体外诊断多变量指数测定法，用于检测早期或低体积卵巢癌

• 批准号: 10376915
• 负责人: IE-MING SHIH
• 金额: $ 30.91万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10376915
• 关键词: Affect; Algorithms; Benign; Bioinformatics; Biological; Biological Assay; Biological Markers; Biometry; Cancer Etiology; Cancer Patient; Carcinoma in Situ; Cervical; Cessation of life; Clinical; Collaborations; Collection; Cytology; DNA; Data; Databases; Detection; Development; Diagnosis; Disease; Early Detection Research Network; Early Diagnosis; Elements; Ensure; Epidemiology; Etiology; Evaluation; Future; Gynecologic Oncologist; High Risk Woman; Individual; Knowledge; Laboratories; Liquid substance; Literature; Low Prevalence; Malignant Female Reproductive System Neoplasm; Malignant Neoplasms; Malignant neoplasm of ovary; Mass Spectrum Analysis; Measures; Operative Surgical Procedures; Ovarian; Ovary; Pathologist; Patients; Pelvis; Performance; Phase; Plasma; Predictive Value; Prevalence; Procedures; Process; Prognosis; Proteomics; Protocols documentation; Reproducibility; Research Personnel; Research Project Grants; Residual Tumors; Risk; Sample Size; Sampling; Screening for Ovarian Cancer; Serous; Specificity; Specimen; Symptoms; Target Populations; Test Result; Testing; Tube; Tumor Debulking; Tumor Volume; United States; Woman; Work; algorithm development; assay development; base; biomarker panel; burden of illness; case control; clinically relevant; cohort; cost; cost effective; design; detection assay; detection test; early detection biomarkers; experience; experimental study; follow-up; high risk population; in vitro Assay; in-vitro diagnostics; indexing; industry partner; member; multidisciplinary; mutant; neoplastic cell; novel marker; performance tests; prediction algorithm; prospective; public health relevance; risk prediction; screening; sound; specific biomarkers; tumor; tumor DNA; validation studies

 DESCRIPTION (provided by applicant): We have assembled a multidisciplinary team including biomarker researchers, cancer biologist, pathologist, gynecologic oncologist, proteomic technologists, and experts in biostatistics, epidemiology, and bioinformatics to establish a Biomarker Developmental Laboratory for the NCI's Early Detection Research Network with the objective to develop an in vitro diagnostic multivariate index assay (IVDMIA) to detect ovarian cancer at low tumor volume. The intended use of such a test is to further enrich ovarian cancer prevalence in high-risk populations to allow for cost-effective additional workup tests. The rationale is based on 1) prognosis of ovarian cancer patients, in addition to stage/grade at diagnosis, is affected by the initial size of the metastatic disease and the size of residual disease after cytoreductive surgery; and 2) newly developed cancer-specific biomarkers detecting mutant DNAs in liquid-based cervical cytology specimens and circulating tumor DNA (ctDNA) in plasma have demonstrated a remarkable specificity. We hypothesize that combining such biomarkers with additional sensitive and disease burden-associated biomarkers in an IVDMIA will allow us to detect ovarian cancer at low volume which currently represents an unmet clinical need.



项目成果

Sub-millimeter endoscope demonstrates feasibility of in vivo reflectance imaging, fluorescence imaging, and cell collection in the fallopian tubes.

• DOI: 10.1117/1.jbo.26.7.076001
• 发表时间: 2021-07
• 期刊: Journal of biomedical optics
• 影响因子: 3.5
• 作者: Cordova R;Kiekens K;Burrell S;Drake W;Kmeid Z;Rice P;Rocha A;Diaz S;Yamada S;Yozwiak M;Nelson OL;Rodriguez GC;Heusinkveld J;Shih IM;Alberts DS;Barton JK
• 通讯作者: Barton JK