Confocal DNA Cytometry Prostate Cancer- Age & Ethnicity

描述（由申请方提供）：共聚焦DNA细胞术使用DNA定量染色的细胞核的3D图像;测量细胞核DNA含量、大小、形状和染色质纹理，并用于推导定量细胞核等级（QNG）。 QNG测量癌细胞核的异常，QNG的变化与基因组不稳定性增加和更具侵袭性的肿瘤行为相关。 与已建立的风险标记物（如Gleason评分）相比，QNG提供了重要且独立的预后信息。 关于前列腺腺癌（PCa），该信息可能在描述具有更普遍的中等Gleason评分（6和7）的PCa时最有用。 如果PCa的生物学随年龄、人种和种族而变化，QNG应检测到此类变化。 三个领域可能在受影响个体的年龄或种族/民族群体所特有的不同临床情景中有用：1）检测。分析癌旁正常细胞核的恶性相关变化可能会提高空芯针活检的有用性。2)诊断. QNG可能提供额外的独立信息，以补充Gleason分级和病理分期。3)预后QNG可能允许更高的敏感性预测隐匿性前列腺外的扩展，复发和/或治疗的反应。 肿瘤相关的变化对于理解正常细胞随着肿瘤的发展以及年龄、人种和种族的进行性变化很重要。 更仔细的监测，化学预防研究的高风险队列的划定，以及临床上不显著的癌症的检测可能都是不同的老年人与年轻人和不同的种族/民族群体;这些问题必须彻底探讨。 QNG检测随年龄、人种和种族的生物学变化的能力还应该通过与增殖、凋亡和/或预后相关的所选分子标志物的表型表达来补充。 在所有年龄组中，根据针吸活检结果和/或根治性标本的结果预测肿瘤的生物学侵袭性和分期对于临床决策至关重要。 我们将使用QNG和分子标记物的水平来预测基于年龄/种族和种族的PCa的侵袭性。 我们将检验阴性假设，即在所有其他预后变量相同的情况下，年龄和种族与肿瘤侵袭性无关。

DESCRIPTION (provided by applicant): Confocal DNA cytometry uses 3D images of nuclei stained quantitatively for DNA; nuclear DNA content, size, shape, and chromatin texture are measured and used to derive a quantitative nuclear grade (QNG). QNG measures abnormalities in cancer nuclei, and changes in QNG have been correlated to increasing genomic instability and more aggressive tumor behavior. QNG provides significant and independent prognostic information when compared to established markers of risk such as the Gleason Score. With respect to prostate adenocarcinoma (PCa), this information may be most useful in describing PCa with more prevalent intermediate Gleason scores (6 and 7). If the biology of PCa varies with age, race and ethnicity, QNG should detect such changes. Three areas might be useful in different clinical scenarios unique to the age or racial/ethnic groups of the affected individuals: 1) Detection. Analysis of malignancy associated changes in normal appearing nuclei adjacent to carcinomas might enhance the usefulness of core needle biopsies. 2) Diagnosis. QNG might provide additional independent information to supplement Gleason grades and pathologic stages. 3) Prognosis. QNG might allow greater sensitivity for the prediction of occult extraprostatic extension, recurrence and/or responsiveness to therapy. Malignancy associated changes are important in understanding progressive changes in normal appearing cells with the development of neoplasia and with age, race, and ethnicity. More careful surveillance, delineation of high-risk cohorts for chemoprevention studies, and detection of clinically insignificant cancer might all be different for elderly vs. younger men and in different racial/ethnic groups; these issues must be explored thoroughly. The ability of QNG to detect biological changes with age, race and ethnicity also should be complemented by phenotypic expression of selected molecular markers which correlate with proliferation, apoptosis and/or prognosis. In all age groups, predicting the biological aggressiveness and stage of tumors, based on needle biopsy findings and/or on the results of radical specimens, is critical for clinical decision making. We will use the levels of QNG and molecular markers to predict the aggressiveness of PCa based on age/race and ethnicity. We will test the negative hypothesis that age and ethnic groups, with all other prognostic variables being equal, will have no correlation with tumor aggressiveness.