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      ESGO/ISUOG/IOTA/ESGE Consensus Statement on pre-operative diagnosis of ovarian tumors

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          Abstract

          The European Society of Gynaecological Oncology (ESGO), the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG), the International Ovarian Tumour Analysis (IOTA) group, and the European Society for Gynaecological Endoscopy (ESGE) jointly developed clinically relevant and evidence-based statements on the pre-operative diagnosis of ovarian tumors, including imaging techniques, biomarkers, and prediction models. ESGO/ISUOG/IOTA/ESGE nominated a multidisciplinary international group, including expert practising clinicians and researchers who have demonstrated leadership and expertise in the pre-operative diagnosis of ovarian tumors and management of patients with ovarian cancer (19 experts across Europe). A patient representative was also included in the group. To ensure that the statements were evidence-based, the current literature was reviewed and critically appraised. Preliminary statements were drafted based on the review of the relevant literature. During a conference call, the whole group discussed each preliminary statement and a first round of voting was carried out. Statements were removed when a consensus among group members was not obtained. The voters had the opportunity to provide comments/suggestions with their votes. The statements were then revised accordingly. Another round of voting was carried out according to the same rules to allow the whole group to evaluate the revised version of the statements. The group achieved consensus on 18 statements. This Consensus Statement presents these ESGO/ISUOG/IOTA/ESGE statements on the pre-operative diagnosis of ovarian tumors and the assessment of carcinomatosis, together with a summary of the evidence supporting each statement.

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          Direct detection of early-stage cancers using circulating tumor DNA

          Early detection and intervention are likely to be the most effective means for reducing morbidity and mortality of human cancer. However, development of methods for noninvasive detection of early-stage tumors has remained a challenge. We have developed an approach called targeted error correction sequencing (TEC-Seq) that allows ultrasensitive direct evaluation of sequence changes in circulating cell-free DNA using massively parallel sequencing. We have used this approach to examine 58 cancer-related genes encompassing 81 kb. Analysis of plasma from 44 healthy individuals identified genomic changes related to clonal hematopoiesis in 16% of asymptomatic individuals but no alterations in driver genes related to solid cancers. Evaluation of 200 patients with colorectal, breast, lung, or ovarian cancer detected somatic mutations in the plasma of 71, 59, 59, and 68%, respectively, of patients with stage I or II disease. Analyses of mutations in the circulation revealed high concordance with alterations in the tumors of these patients. In patients with resectable colorectal cancers, higher amounts of preoperative circulating tumor DNA were associated with disease recurrence and decreased overall survival. These analyses provide a broadly applicable approach for noninvasive detection of early-stage tumors that may be useful for screening and management of patients with cancer.
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            Terms, definitions and measurements to describe the sonographic features of adnexal tumors: a consensus opinion from the International Ovarian Tumor Analysis (IOTA) Group.

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              Simple ultrasound rules to distinguish between benign and malignant adnexal masses before surgery: prospective validation by IOTA group

              Objectives To prospectively assess the diagnostic performance of simple ultrasound rules to predict benignity/malignancy in an adnexal mass and to test the performance of the risk of malignancy index, two logistic regression models, and subjective assessment of ultrasonic findings by an experienced ultrasound examiner in adnexal masses for which the simple rules yield an inconclusive result. Design Prospective temporal and external validation of simple ultrasound rules to distinguish benign from malignant adnexal masses. The rules comprised five ultrasonic features (including shape, size, solidity, and results of colour Doppler examination) to predict a malignant tumour (M features) and five to predict a benign tumour (B features). If one or more M features were present in the absence of a B feature, the mass was classified as malignant. If one or more B features were present in the absence of an M feature, it was classified as benign. If both M features and B features were present, or if none of the features was present, the simple rules were inconclusive. Setting 19 ultrasound centres in eight countries. Participants 1938 women with an adnexal mass examined with ultrasound by the principal investigator at each centre with a standardised research protocol. Reference standard Histological classification of the excised adnexal mass as benign or malignant. Main outcome measures Diagnostic sensitivity and specificity. Results Of the 1938 patients with an adnexal mass, 1396 (72%) had benign tumours, 373 (19.2%) had primary invasive tumours, 111 (5.7%) had borderline malignant tumours, and 58 (3%) had metastatic tumours in the ovary. The simple rules yielded a conclusive result in 1501 (77%) masses, for which they resulted in a sensitivity of 92% (95% confidence interval 89% to 94%) and a specificity of 96% (94% to 97%). The corresponding sensitivity and specificity of subjective assessment were 91% (88% to 94%) and 96% (94% to 97%). In the 357 masses for which the simple rules yielded an inconclusive result and with available results of CA-125 measurements, the sensitivities were 89% (83% to 93%) for subjective assessment, 50% (42% to 58%) for the risk of malignancy index, 89% (83% to 93%) for logistic regression model 1, and 82% (75% to 87%) for logistic regression model 2; the corresponding specificities were 78% (72% to 83%), 84% (78% to 88%), 44% (38% to 51%), and 48% (42% to 55%). Use of the simple rules as a triage test and subjective assessment for those masses for which the simple rules yielded an inconclusive result gave a sensitivity of 91% (88% to 93%) and a specificity of 93% (91% to 94%), compared with a sensitivity of 90% (88% to 93%) and a specificity of 93% (91% to 94%) when subjective assessment was used in all masses. Conclusions The use of the simple rules has the potential to improve the management of women with adnexal masses. In adnexal masses for which the rules yielded an inconclusive result, subjective assessment of ultrasonic findings by an experienced ultrasound examiner was the most accurate diagnostic test; the risk of malignancy index and the two regression models were not useful.
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                Author and article information

                Journal
                Int J Gynecol Cancer
                Int J Gynecol Cancer
                ijgc
                ijgc
                International Journal of Gynecological Cancer
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                1048-891X
                1525-1438
                July 2021
                10 June 2021
                : 31
                : 7
                : 961-982
                Affiliations
                [1 ] departmentGynecology and Obstetrics , University Hospitals KU Leuven , Leuven, Belgium
                [2 ] departmentDevelopment and Regeneration , KU Leuven , Leuven, Belgium
                [3 ] departmentClinical Research Unit , Institut Bergonie , Bordeaux, France
                [4 ] departmentMetabolism Digestion and Reproduction , Queen Charlotte’s & Chelsea Hospital, Imperial College , London, UK
                [5 ] departmentWoman, Child and Public Health , Fondazione Policlinico Universitario A Gemelli IRCCS , Rome, Italy
                [6 ] departmentGynaecology and Gynaecological Oncology , Evangelische Kliniken Essen-Mitte , Essen, Germany
                [7 ] departmentGynaecology and Obstetrics , University Clinic of Navarra , Madrid, Spain
                [8 ] departmentObstetrics and Gynaecology, First Faculty of Medicine , Charles University and General University Hospital in Prague , Prague, Czech Republic
                [9 ] departmentObstetrics and Gynecology , Medical University of Innsbruck , Innsbruck, Austria
                [10 ] departmentRadiology , University Clinic of Navarra , Madrid, Spain
                [11 ] European Network of Gynaecological Cancers Advocacy Groups (ENGAGe) Executive Group , Prague, Czech Republic
                [12 ] KIU - Patient Organisation for Women with Gynaecological Cancer , Copenhagen, Denmark
                [13 ] departmentClinical Physiology, Nuclear Medicine & PET , Rigshospitalet, Copenhagen University Hospital , Copenhagen, Denmark
                [14 ] departmentGynecology and Obstetrics, Gynecologic Oncology Unit , Santa Chiara Hospital , Trento, Italy
                [15 ] departmentGynaecological Surgery , Institut Gustave Roussy , Villejuif, France
                [16 ] departmentGynecologic Oncology , Fondazione Policlinico Universitario A Gemelli IRCCS , Rome, Italy
                [17 ] departmentObstetrics and Gynecologic Oncology , University Hospital , Strasbourg, France
                [18 ] departmentObstetrics and Gynecology , Università Cattolica del Sacro Cuore , Rome, Italy
                [19 ] departmentObstetrics and Gynaecology and Gynaecologic Oncology , University Hospital Leuven, Leuven Cancer Institute , Leuven, Belgium
                [20 ] departmentRadiology , University Hospitals Leuven , Leuven, Belgium
                [21 ] departmentDivision of Translational MRI, Department of Imaging and Pathology , KU Leuven , Leuven, Belgium
                [22 ] departmentGynaecologic Oncology , Hammersmith Hospital, Imperial College , London, UK
                Author notes
                [Correspondence to ] Professor Dirk Timmerman, Gynecology and Obstetrics, University Hospitals KU Leuven, Leuven, Belgium; Dirk.timmerman@ 123456uzleuven.be
                Author information
                http://orcid.org/0000-0002-3707-6645
                http://orcid.org/0000-0003-1421-6059
                http://orcid.org/0000-0001-9808-7957
                http://orcid.org/0000-0002-1908-3251
                http://orcid.org/0000-0001-6387-9356
                http://orcid.org/0000-0002-9795-2643
                http://orcid.org/0000-0002-7224-3218
                http://orcid.org/0000-0002-1398-9124
                http://orcid.org/0000-0002-7502-3544
                http://orcid.org/0000-0002-3984-4812
                http://orcid.org/0000-0003-2217-8726
                http://orcid.org/0000-0002-0800-3279
                http://orcid.org/0000-0001-6375-9645
                Article
                ijgc-2021-002565
                10.1136/ijgc-2021-002565
                8273689
                34112736
                21953018-ab23-4907-b4fc-0e4330155a9b
                © IGCS and ESGO 2021. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, an indication of whether changes were made, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 25 February 2021
                : 08 March 2021
                Categories
                Joint Statement
                1506
                1507
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                ovarian neoplasms,ovary
                ovarian neoplasms, ovary

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