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  • American Society of Clinical Oncology (ASCO)  (4)
  • 1
    Online Resource
    Online Resource
    A sensitive and quantitative multimodal blood test for the detection of colorectal adenomas and cancer: Correlation with size and number of polyps.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 1555-1555
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 1555-1555
    Abstract: 1555 Background: Colonoscopic polypectomy is the primary reason for declining colorectal cancer incidence and mortality. Epidemiological evidence has ordered the timing and risk of pre-cancerous adenomas, localized and invasive cancer along a 7-10 year continuum. The increased size and number of index polyps are correlated with an increased probability of progression to cancer and informs surveillance colonoscopies. Methods: A single-center, IRB-approved, prospective, blinded study was conducted at the VA Palo Alto Health Care System. Results for 354 patients with no prior diagnosis of CRC who were scheduled for colonoscopy are presented. Indications for colonoscopy were 86% asymptomatic and 14% with symptoms or positive-FIT. Patients had blood drawn immediately prior to colonoscopy. The test analyzes three biomarkers: circulating gastrointestinal epithelial cells (CEC), validated somatic mutations, and methylation (SEPTIN9) of cell-free DNA and uses incident risk to calculate a CMx Score, scaled from 0 to 100. Multivariate regression methods were used to assess the degree of association between the pre-defined CMx Scores and polyp sizes and number, adjusting for both DNA mutation and DNA methylation status. Results: There is a significant association between CMx Scores and polyp size (F value = 5.80, p-value = 0.017). DNA mutation (F value = 1.29, p-value = 0.263) and methylation status (F value = 0.34, p-value = 0.560) were non-significant. Similarly, there is a significant association between CMx Scores and number of polyps (F value = 23.71, p-value 〈 0.0001). Again, DNA mutation (F value = 1.57, p-value = 0.210) and methylation status (F value = 1.34, p-value = 0.248) were non-significant. These results suggest that CMx Scores, which incorporate CEC, are providing predictive information of polyp sizes and number above and beyond DNA mutation and methylation status alone. Conclusions: A novel noninvasive multimodal blood-based assay that analyzes cell-free DNA for somatic mutations and methylation, CEC and integrates SEER incidence risk is significantly associated with polyp size and number. The opportunity to track progression and potentially inform colonoscopy interval is notable. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.1555
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 2
    Online Resource
    Online Resource
    Development and clinical validation of a blood test for early detection of colorectal adenomas and cancer.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 3_suppl ( 2021-01-20), p. 50-50
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 3_suppl ( 2021-01-20), p. 50-50
    Abstract: 50 Background: Many of the 50,000 annual colorectal cancer (CRC) deaths can be attributed to 1/3 eligible Americans not following screening guidelines or approximately 1/2 of the population not adherent to the follow-up post-polypectomy guidelines. The new understanding of the natural history and shared etiology of adenomas and CRC inform integration of clinically relevant biomarkers. The two objectives of CRC screening and surveillance are early detection to improve survival and prevention of CRC through removal of adenomas using colonoscopy. Adenomas account for 98% of actionable colonoscopies. Stool tests have low sensitivity for advanced adenomas (AA, 24-42%). Methods: A prospective, blinded study was conducted at the VA Palo Alto Health Care System. Patients had blood drawn prior to colonoscopy. The test analyzes two biomarkers: circulating gastrointestinal epithelial cells and somatic mutations of cell-free DNA. The probability of advanced neoplasia was obtained by ordinal/nominal logistic regression methods together with SEER-incidence rate and prior history of AA on a training set of 346 subjects. The cutpoint for the quantitative score was fixed and the remaining 112 subjects were tested. Results: Interim results for 458 patients with no prior diagnosis of colorectal cancer (CRC) are presented. The cohort included both screening (239) and surveillance (219) subjects. Indications for colonoscopy were 86% asymptomatic and 14% with symptoms or positive-FIT. Balanced distribution of roughly 3/4 th subjects in each disease category were randomly selected for training and algorithm development and the remaining 1/4 th subjects were used for validation. A cutpoint was selected to obtain a test specificity (non-neoplastic finding or negative colonoscopy) of 90% resulting in a sensitivity of 100% and 80.0% for detection of CRC and advanced neoplasia (AN = CRC+AA), respectively, on the training subjects. The area under the ROC curve is 0.91. Validation using the fixed cutpoint and 112 test subjects achieved 91.4% specificity and 100% and 75.0% sensitivity for CRC and AN. Conclusions: This blood test has high sensitivity for colorectal advanced neoplasia while retaining high specificity. The quantitative nature of the score has the potential to enable stratification of patients for screening or post-polypectomy surveillance colonoscopy. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.3_suppl.50
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 3
    Online Resource
    Online Resource
    Perspectives on healthcare providers’ role in health promotion among cancer survivors.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e24037-e24037
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e24037-e24037
    Abstract: e24037 Background: To further integrate health promotion into cancer survivorship care, we explored multilevel perspectives on potential roles healthcare providers could have in promoting uptake of web-based healthy lifestyle programs among cancer survivors. Methods: In developing the Aim, Plan, and Act on Lifestyles (AMPLIFY) Survivor Health diet and exercise web-based program, we conducted 10 focus groups with 57 cancer survivors and 27 individual semi-structured interviews with stakeholders representing advocacy groups (e.g., cancer survivorship support foundations; n = 8), cancer organizations (e.g., industry, health system; n = 11), and survivors’ supportive partners (n = 8). Verbatim transcripts were analyzed by multiple coders using inductive thematic analysis with NVivo 12. Results: Survivors (49% female; 40% African-American, mean age 63.7 years) and stakeholders (60% female) stated that healthcare provider and health system recommendation and support are vital for ensuring acceptance and use of web-based healthy lifestyle programs by cancer survivors. Survivors expressed that physician’s (e.g., oncologist, other physician) recommendation and support would motivate them to join and participate. Supportive partners also endorsed the importance of provider recommendations and the key role of health system support (e.g., reminders in doctor’s office, hospitals, web-based portal, and endorsement from cancer centers). Advocacy group representatives underscored the importance of data-driven support for the effects of such programs as critical for promotion. Moreover, technology supported continuous cancer care (e.g., physician communication and feedback) were seen as critical for sustained participation. Stakeholders from cancer organizations suggested survivors in need could be identified and referred during assessments in various cancer care clinics. This group also emphasized the need to integrate evidence-based healthy lifestyle recommendations into continuing medical education, medical board certifications, support and referrals into existing standard of cancer care, and to involve other key stakeholders and larger scale health systems in promotion. Conclusions: Healthcare providers and health systems have important roles in promoting and sustaining participation in web-based healthy lifestyle programs among cancer survivors. Further work developing, testing, and refining strategies to enhance their role in promoting the acceptability and uptake of healthy lifestyle programs by cancer survivors are needed.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.e24037
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 4
    Online Resource
    Online Resource
    Evaluation of differential contribution of a circulating epithelial cell signal component in a multimodal colorectal neoplasia assay.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. e15527-e15527
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. e15527-e15527
    Abstract: e15527 Background: Multimodal diagnostic classifiers survey signals from multiple biological compartments and provide iterative, independent and interactive information. Detection of both CRC and AA is critical for noninvasive colorectal screening to improve overall survival and prevent the 2.5-5% annual transition of AA to CRC. FirstSight integrates clinically validated somatic variants from cfDNA and circulating epithelial cells (CECs) adjusting for age and sex. CECs provide information from both intrinsic factors of the adenoma and extrinsic factors such as adenoma microenvironment which facilitates early systemic entry. We sought to assess differential information from CEC signals for the detection of colorectal cancer and/or advanced adenoma (AA). Methods: Blood samples and colonoscopy pathology results were obtained from 438 asymptomatic screening subjects enriched for CRC/AA obtained from 15 US medical centers. The cohort included 18 CRCs and 64 AAs. Somatic variants from cfDNA were identified using NGS and qPCR. CECs were captured by the CellMax biomimetic platform (CMx) using high-avidity EpCAM antibody embedded in the CMx biochip and confirmed with immunostaining (DAPI: nucleus, CK20: epithelial cell and CD45: WBC). CMx platform’s AI/ML analyses of CEC images quantify stain intensities and cellular features. CEC derived signal GM1was evaluated for its predictive capability beyond somatic variants from cfDNA. Results: Genetic or epigenetic variants were not detected in 52% (33/64) of AA cases, limiting the sensitivity of these markers for early disease. However, distinct CEC signals have been identified that aid in the detection of subjects with CRC or AA, or conversely subjects with negative colonoscopies or non-advanced adenomas (nAA). Among them, a novel feature (referred to as GM1) derived from CEC signals was able to differentiate with statistical significance AA from negative/non-neoplastic findings or nAAs in study subjects with negative results in corresponding somatic variants from cfDNA (p 〈 0.0001). While targeted somatic variants from cfDNA performed well on CRC (17/18), they provided no predictive information for detection of AA for the 353 subjects which were negative for variants, GM1 provided 100.0% (33/33) sensitivity at 35.1% (112/319) specificity, showing its ability to rule out AA with high negative predictive value. Conclusions: Somatic variant detection modes of the First Sight multi-modal assay have high sensitivity for CRC and modest sensitivity for AA. We demonstrate that CEC signal GM1 of FirstSight provides significant independent information for the detection of CRC and AA beyond somatic variants from cfDNA. Additional CEC signals may further improve the sensitivity and specificity for detection of early-stage colorectal neoplasia. The GM1 CEC signal marker will need to be validated further in future studies.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.e15527
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
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