Evaluation of biomarkers in the detection of malignant neoplasia in women with adnexal mass

• Grant number: 12/15059-8
• Support Opportunities: Regular Research Grants
• Duration: November 01, 2012 - October 31, 2015
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: Sophie Françoise Mauricette Derchain
• Grantee: Sophie Françoise Mauricette Derchain
• Host Institution: Centro de Atenção Integral à Saúde da Mulher (CAISM). Hospital da Mulher Professor Doutor José Aristodemo Pinotti. Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil

Abstract

This project pertains to a line of research on potential clinical, sonographic and biochemical predictors of malignancy in women with adnexal tumors. The objective of the study is to evaluate the accuracy of CA125, HE4 and mesotelin, standing alone or combined with sonographic findings and symptoms to differentiate ovarian tumors in women who underwent a laparotomy due to an adnexal mass. Subjects and methods: this diagnostic validation study included women who attended consultations at the pelvic oncology - ovary clinics and who were scheduled to undergo a laparoscopy/laparotomy due to an adnexal mass in the Women's Hospital of the Campinas State University (CAISM-Unicamp). The patients group comprised women aged 18 years of above, with an adnexal tumor and an indication to undergo surgery, to be performed in CAISM, and the control group consisted of clinically healthy women with normal pelvic exam and ultrasound. Women undergoing treatments for cancer, those who had undergone an oophorectomy and/or pregnant were excluded. After signing the informed consent form, 312 women with ovarian tumors and 152 controls were included. The sample size was calculated on the basis of the sensitivity of CA125 and HE4 derived from previous studies, with 5% significance levels, 80% statistical power and 12% error limits for the sensitivity, according to the calculations proposed by Flahaul: the minimal size would be n=93(malignant), and based on the prevalence of malignancy, n=149 benignant tumors. The number of controls was estimated at n=149, totaling n=391. We started accrual in 2010 and after enrolling, all women responded to a structured interview concerning 24 symptoms related to ovarian cancer over the 12 months before the consultation. All patients underwent transvaginal sonography (associated or not with abdominal sonography) for the evaluation of the tumor characteristics, which were classified following strict criteria. Women with an indication for surgery for the diagnosis and/or treatment were operated in CAISM. Peripheral blood samples were collected from patients and controls. The 10mL samples were stored in dry tubes and immediately frozen. The blood samples were then left to rest for 30 minutes, allowing clot formation and were next centrifuged in 1200g for 10 minutes. The total volume of serum thereby obtained was separated into 300µl aliquots and stored in -80ºC for future biomarker detection and quantification. Manuscripts derived from the present line of research have already been prepared: the first one (in press) addresses the sonographic findings ((Hartman CA, Juliato CR, Sarian LO, Toledo MC, Jales RM, Morais SS, Pitta DD, Marussi EF, Derchain S. Ultrasound criteria and CA-125 as predictive variables of ovarian cancer in women with adnexal tumors. Ultrasound Obstet Gynecol. 2012 May 30. doi: 10.1002/uog.11201). The second has been submitted in the American Journal of Obstetrics and Gynecology (Barreta A, Bastos J, Sarian L, Toledo MC, Hartman C, Sallum LF, Pitta D, Derchain S. Laparotomy and Laparoscopy for Diagnosis and Treatment of Adnexal Masses at a Brazilian Oncology Center and Factors That Led to Laparoscopy Failure). With the analysis of the tumor markers, we expect to fulfill the main objective of the study, which is to assess the sonographic features, symptoms and biological markers, standing alone or in multiple combinations, as tools for the differentiation of adnexal masses. (AU)

Scientific publications

(17)

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

ARAUJO, K. G.; JALES, R. M.; PEREIRA, P. N.; YOSHIDA, A.; DE ANGELO ANDRADE, L.; SARIAN, L. O.; DERCHAIN, S.. Performance of the IOTA ADNEX model in preoperative discrimination of adnexal masses in a gynecological oncology center. ULTRASOUND IN OBSTETRICS & GYNECOLOGY, v. 49, n. 6, p. 778-783, JUN 2017. (12/15059-8)

ELEN SOUZA; ADRIANA YOSHIDA; HELOISA PERES; LILIANA DE ANGELO ANDRADE; LUIS OTÁVIO SARIAN; SOPHIE DERCHAIN. Preservação da fertilidade e dos ovários em mulheres com tumores anexiais benignos. Revista Brasileira de Ginecologia e Obstetrícia, v. 37, n. 1, p. 36-41, 2015-01-00. (12/15059-8)

PITTA, DENISE DA ROCHA; SARIAN, LUIS OTAVIO; BARRETA, AMILCAR; CAMPOS, ELISABETE APARECIDA; DE ANGELO ANDRADE, LILIANA LUCCI; DIAS FACHINI, ANA MARIA; CAMPBELL, LEONARDO MARTINS; DERCHAIN, SOPHIE. Symptoms, CA125 and HE4 for the preoperative prediction of ovarian malignancy in Brazilian women with ovarian masses. BMC CANCER, v. 13, SEP 18 2013. (12/15059-8)

PITTA, DENISE DA ROCHA; SARIAN, LUIS OTAVIO; CAMPOS, ELISABETE APARECIDA; DE ANGELO ANDRADE, LILIANA LUCCI; SALLUM, LUIS FELIPE; BRAGANCA, JOANA FROES; CAMPOS, CAMILA DE MELLO; DERCHAIN, SOPHIE. HE4 can help discriminate women with malignant ovarian tumors only if CA125 levels are elevated. International Journal of Biological Markers, v. 28, n. 4, p. E377-E386, OCT-DEC 2013. (12/15059-8)

DE ARAUJO RESENDE, LEANDRO SANTOS; RABELO-SANTOS, SILVIA HELENA; SARIAN, LUIS OTAVIO; FIGUEIREDO ALVES, ROSANE RIBEIRO; RIBEIRO, ANDREA ALVES; ZEFERINO, LUIZ CARLOS; DERCHAIN, SOPHIE. A portrait of single and multiple HPV type infections in Brazilian women of different age strata with squamous or glandular cervical lesions. BMC INFECTIOUS DISEASES, v. 14, APR 22 2014. (12/15059-8)

BARRETA, AMILCAR; SARIAN, LUIS; FERRACINI, AMANDA CANATO; ELOY, LARISSA; CARVALHO BRITO, ANGELO BORSARELLI; ANDRADE, LILIANA DE ANGELO; DERCHAIN, SOPHIE. Endometriosis-Associated Ovarian Cancer Population Characteristics and Prognosis. International Journal of Gynecological Cancer, v. 28, n. 7, p. 1251-1257, SEP 2018. (12/15059-8, 16/07822-4)

YOSHIDA, ADRIANA; DERCHAIN, SOPHIE F.; PITTA, DENISE R.; CROZATTI, NATHALIA; ANDRADE, LILIANA A. L. A.; DA SILVA, RODRIGO F.; SARIAN, LUIS O.. Preoperative measurement of serum C-reactive protein: is it useful in the differential diagnosis of adnexal masses?. International Journal of Biological Markers, v. 32, n. 1, p. E83-E89, JAN-MAR 2017. (12/15059-8)

PEREIRA, PATRICK NUNES; DERCHAIN, SOPHIE FRANCOISE; YOSHIDA, ADRIANA; BARROS, RICARDO HOELZ DE OLIVEIRA; JALES, RODRIGO MENEZES; SARIAN, LUIS OTAVIO. Diffusion-weighted magnetic resonance sequence and CA125/CEA ratio can be used as add-on tools to ultrasound for the differentiation of ovarian from non-ovarian pelvic masses. PLoS One, v. 18, n. 3, p. 13-pg., 2023-03-16. (12/15059-8)

BARRETA, AMILCAR; SARIAN, LUIS OTAVIO; FERRACINI, AMANDA CANATO; ELOY COSTA, LARISSA BASTOS; MAZZOLA, PRISCILA GAVA; ANDRADE, LILIANA DE ANGELO; DERCHAIN, SOPHIE. Immunohistochemistry expression of targeted therapies biomarkers in ovarian clear cell and endometrioid carcinomas (type I) and endometriosis. HUMAN PATHOLOGY, v. 85, p. 72-81, MAR 2019. (12/15059-8, 16/07822-4)

BAPTISTA, MAURICIO Z.; SARIAN, LUIS OTAVIO; DERCHAIN, SOPHIE F. M.; PINTO, GLAUCE A.; VASSAL, JOSE. Prognostic significance of PD-L1 and PD-L2 in breast cancer. HUMAN PATHOLOGY, v. 47, n. 1, p. 78-84, JAN 2016. (12/15059-8, 13/25683-3, 08/02469-8)

BARRETA, AMILCAR; SALLUM, LUIS FELIPE; SARIAN, LUIS OTAVIO; BRAGANCA BASTOS, JOANA FROES; DERCHAIN, SOPHIE. Criteria for Selection of Laparoscopy for Women with Adnexal Mass. JSLS-JOURNAL OF THE SOCIETY OF LAPAROENDOSCOPIC SURGEONS, v. 18, n. 3, JUL-SEP 2014. (12/15059-8)

SALLUM, LUIS FELIPE; ANDRADE, LILIANA; ELOY DA COSTA, LARISSA BASTOS; RAMALHO, SUSANA; FERRACINI, AMANDA CANATO; NATAL, RODRIGO DE ANDRADE; CARVALHO BRITO, ANGELO BORSARELLI; SARIAN, LUIS OTAVIO; DERCHAIN, SOPHIE. BRCA1, Ki67, and -Catenin Immunoexpression Is Not Related to Differentiation, Platinum Response, or Prognosis in Women With Low- and High-Grade Serous Ovarian Carcinoma. International Journal of Gynecological Cancer, v. 28, n. 3, p. 437-447, MAR 2018. (12/15059-8)

TIAGO AUGUSTO GOMES; ELIZABETH APARECIDA CAMPOS; ADRIANA YOSHIDA; LUÍS OTAVIO SARIAN; LILIANA APARECIDA LUCCI DE ANGELO ANDRADE; SOPHIE FRANÇOISE DERCHAIN. Diferenciação pré-operatória de tumores ovarianos não epiteliais benignos e malignos: características clínicas e marcadores tumorais. Revista Brasileira de Ginecologia e Obstetrícia, v. 42, n. 9, p. 555-561, 2020-10-23. (12/15059-8)

JALES, RODRIGO MENEZES; ARAUJO, KARLA GALVAO; ZANATA SARIAN, LUIS OTAVIO; SERRA, KATIA PITON; KEPPKE, HELENA; FRANCISCO, JULIANA; MAURICETTE DERCHAIN, SOPHIE FRANCOISE. Cistos no interior de nódulo mamários benignos: risco de malignidade. Revista Brasileira de Ginecologia e Obstetrícia, v. 38, n. 4, p. 170-176, APR 2016. (12/15059-8)

YOSHIDA, ADRIANA; DERCHAIN, SOPHIE FRANCOISE; PITTA, DENISE ROCHA; LUCCI DE ANGELO ANDRADE, LILIANA APARECIDA; SARIAN, LUIS OTAVIO. Comparing the Copenhagen Index (CPH-I) and Risk of Ovarian Malignancy Algorithm (ROMA): Two equivalent ways to differentiate malignant from benign ovarian tumors before surgery?. GYNECOLOGIC ONCOLOGY, v. 140, n. 3, p. 481-485, MAR 2016. (12/15059-8)

YOSHIDA, ADRIANA; SARIAN, LUIS OTAVIO; MARANGONI JUNIOR, MARCOS; FIRMANO, ISIS CAROLINE; DERCHAIN, SOPHIE FRANCOISE. Diagnostic Value of the Neutrophil/Lymphocyte Ratio, Platelet/Lymphocyte Ratio, and Thrombocytosis in the Preoperative Investigation of Ovarian Masses. Revista Brasileira de Ginecologia e Obstetrícia, v. 42, n. 7, p. 397-403, JUL 2020. (12/15059-8)

PEREIRA, PATRICK NUNES; SARIAN, LUIS OTAVIO; YOSHIDA, ADRIANA; ARAUJO, KARLA GALVAO; BAIAO SILVA, ANA CAROLINA; DE OLIVEIRA BARROS, RICARDO HOELZ; JALES, RODRIGO MENEZES; DERCHAIN, SOPHIE. Improving the performance of IOTA simple rules: sonographic assessment of adnexal masses with resource-effective use of a magnetic resonance scoring (ADNEX MR scoring system). ABDOMINAL RADIOLOGY, v. 45, n. 10, p. 3218-3229, OCT 2020. (12/15059-8)