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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05974618
Other study ID # S66455
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 5, 2023
Est. completion date July 2026

Study information

Verified date July 2023
Source Universitaire Ziekenhuizen KU Leuven
Contact Dirk Timmerman, Professor
Phone +3216344201
Email dirk.timmerman@uzleuven.be
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Prospective Validation of the ADNEX Model for discrimination between benign and malignant adnexal masses in pregnancy: International Ovarian Tumour Analysis in pregnancy study (p-IOTA)


Description:

1. STUDY SUMMARY TITLE Prospective Validation of the ADNEX Model for discrimination between benign and malignant adnexal masses in pregnancy: the International Ovarian Tumour Analysis in pregnancy study (p-IOTA). DESIGN Multicentre, prospective cohort observational study. BACKGROUND Adnexal masses are a common incidental finding in pregnancy. Whilst the majority are benign and resolve spontaneously, a proportion can exhibit suspicious features during pregnancy raising concern about an underlying malignancy. Correct classification of adnexal masses is particularly important during pregnancy given the potential foetal and maternal risks associated with surgical intervention. International Ovarian Tumour Analysis (IOTA) group have developed robust, ultrasound-based tools, including the ADNEX model to support the classification of adnexal masses. Ultrasound-based tools such the Modified Benign Simple Descriptors and ADNEX have been externally validated to aid in the classification of adnexal masses in non-pregnant women, but their use as a robust diagnostic tool in pregnancy remains to be demonstrated. AIMS The principal objective of this study is to prospectively investigate the ability of the ADNEX Model and a 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) to correctly discriminate between benign and malignant adnexal masses diagnosed in pregnancy. PRIMARY OUTCOME MEASURE False discovery rate (number of benign masses / number of masses classified as malignant) when using the ADNEX Model to discriminate between benign and malignant adnexal masses at 11-14 gestational weeks in pregnancy. ELIGIBILITY All women 18 years old and above with an adnexal mass found on ultrasound scan during pregnancy - irrespective of whether the mass known before pregnancy OR diagnosed for the first time on ultrasound scan during pregnancy. DURATION This study will be conducted over a minimum period of three years. KEYWORDS IOTA, ovarian mass, benign, malignant, ultrasound, pregnancy, post-partum


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date July 2026
Est. primary completion date July 2026
Accepts healthy volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - • Consecutive patients with non-physiological adnexal masses or physiological cysts measuring 5cm or more in largest dimension; - In case of more than one mass seen, only most suspicious mass to be included OR in case of two similar masses, the one with the largest dimension or most easily accessible with ultrasound; - Previously recruited patient presenting with a different mass in subsequent pregnancy; - Age 18 years and above. Exclusion Criteria: - • Cysts deemed to be clearly physiological WHEN smaller than 5 cm (largest diameter); - Non-adnexal masses, e.g. peritoneal inclusion cysts (when diagnosis is certain) and peritoneal carcinomatosis with no adnexal mass; - The denial or withdrawal of written informed consent; - Same cyst already recruited for p-IOTA in a previous pregnancy. - Age < 18 years

Study Design


Intervention

Diagnostic Test:
Ultrasound
A standardised transvaginal (supplemented with transabdominal if transvaginal is not sufficient) examination is performed. When a colour Doppler ultrasound examination is performed, the pulse repetition frequency should be 0.3-0.6 KHz. The colour Doppler gain should be increased until colour Doppler artefacts appear and then lowered until just below the reappearance of colour Doppler artefacts. Ultrasound frequency and "priority" (grey scale or colour/Power Doppler) must also be optimised when using colour/power Doppler. Doppler ultrasound should be used with all masses included, irrespective of gestational age.

Locations

Country Name City State
Belgium UZ Leuven Leuven Vlaams-Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (47)

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Ginath S, Shalev A, Keidar R, Kerner R, Condrea A, Golan A, Sagiv R. Differences between adnexal torsion in pregnant and nonpregnant women. J Minim Invasive Gynecol. 2012 Nov-Dec;19(6):708-14. doi: 10.1016/j.jmig.2012.07.007. — View Citation

Goh WA, Rincon M, Bohrer J, Tolosa JE, Sohaey R, Riano R, Davis J, Zalud I. Persistent ovarian masses and pregnancy outcomes. J Matern Fetal Neonatal Med. 2013 Jul;26(11):1090-3. doi: 10.3109/14767058.2013.768980. Epub 2013 Feb 21. — View Citation

Hasson J, Tsafrir Z, Azem F, Bar-On S, Almog B, Mashiach R, Seidman D, Lessing JB, Grisaru D. Comparison of adnexal torsion between pregnant and nonpregnant women. Am J Obstet Gynecol. 2010 Jun;202(6):536.e1-6. doi: 10.1016/j.ajog.2009.11.028. Epub 2010 Jan 8. — View Citation

Hoo WL, Yazbek J, Holland T, Mavrelos D, Tong EN, Jurkovic D. Expectant management of ultrasonically diagnosed ovarian dermoid cysts: is it possible to predict outcome? Ultrasound Obstet Gynecol. 2010 Aug;36(2):235-40. doi: 10.1002/uog.7610. — View Citation

Hoover K, Jenkins TR. Evaluation and management of adnexal mass in pregnancy. Am J Obstet Gynecol. 2011 Aug;205(2):97-102. doi: 10.1016/j.ajog.2011.01.050. Epub 2011 May 14. — View Citation

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Korenaga TK, Tewari KS. Gynecologic cancer in pregnancy. Gynecol Oncol. 2020 Jun;157(3):799-809. doi: 10.1016/j.ygyno.2020.03.015. Epub 2020 Apr 5. — View Citation

Leiserowitz GS, Xing G, Cress R, Brahmbhatt B, Dalrymple JL, Smith LH. Adnexal masses in pregnancy: how often are they malignant? Gynecol Oncol. 2006 May;101(2):315-21. doi: 10.1016/j.ygyno.2005.10.022. Epub 2005 Nov 28. — View Citation

Mascilini F, Savelli L, Scifo MC, Exacoustos C, Timor-Tritsch IE, De Blasis I, Moruzzi MC, Pasciuto T, Scambia G, Valentin L, Testa AC. Ovarian masses with papillary projections diagnosed and removed during pregnancy: ultrasound features and histological diagnosis. Ultrasound Obstet Gynecol. 2017 Jul;50(1):116-123. doi: 10.1002/uog.17216. — View Citation

Morice P. Borderline tumours of the ovary and fertility. Eur J Cancer. 2006 Jan;42(2):149-58. doi: 10.1016/j.ejca.2005.07.029. Epub 2005 Dec 2. — View Citation

Moro F, Mascilini F, Pasciuto T, Leombroni M, Li Destri M, De Blasis I, Garofalo S, Scambia G, Testa AC. Ultrasound features and clinical outcome of patients with malignant ovarian masses diagnosed during pregnancy: experience of a gynecological oncology ultrasound center. Int J Gynecol Cancer. 2019 Sep;29(7):1182-1194. doi: 10.1136/ijgc-2019-000373. Epub 2019 Jul 19. — View Citation

Mukhopadhyay A, Shinde A, Naik R. Ovarian cysts and cancer in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2016 May;33:58-72. doi: 10.1016/j.bpobgyn.2015.10.015. Epub 2015 Oct 30. — View Citation

Nustad K, Bast RC Jr, Brien TJ, Nilsson O, Seguin P, Suresh MR, Saga T, Nozawa S, Bormer OP, de Bruijn HW, Nap M, Vitali A, Gadnell M, Clark J, Shigemasa K, Karlsson B, Kreutz FT, Jette D, Sakahara H, Endo K, Paus E, Warren D, Hammarstrom S, Kenemans P, Hilgers J. Specificity and affinity of 26 monoclonal antibodies against the CA 125 antigen: first report from the ISOBM TD-1 workshop. International Society for Oncodevelopmental Biology and Medicine. Tumour Biol. 1996;17(4):196-219. doi: 10.1159/000217982. — View Citation

Pateman K, Moro F, Mavrelos D, Foo X, Hoo WL, Jurkovic D. Natural history of ovarian endometrioma in pregnancy. BMC Womens Health. 2014 Oct 15;14:128. doi: 10.1186/1472-6874-14-128. — View Citation

Poder L, Coakley FV, Rabban JT, Goldstein RB, Aziz S, Chen LM. Decidualized endometrioma during pregnancy: recognizing an imaging mimic of ovarian malignancy. J Comput Assist Tomogr. 2008 Jul-Aug;32(4):555-8. doi: 10.1097/RCT.0b013e31814685ca. — View Citation

Riley RD, Debray TPA, Collins GS, Archer L, Ensor J, van Smeden M, Snell KIE. Minimum sample size for external validation of a clinical prediction model with a binary outcome. Stat Med. 2021 Aug 30;40(19):4230-4251. doi: 10.1002/sim.9025. Epub 2021 May 24. — View Citation

Sarandakou A, Protonotariou E, Rizos D. Tumor markers in biological fluids associated with pregnancy. Crit Rev Clin Lab Sci. 2007;44(2):151-78. doi: 10.1080/10408360601003143. — View Citation

Sayasneh A, Ferrara L, De Cock B, Saso S, Al-Memar M, Johnson S, Kaijser J, Carvalho J, Husicka R, Smith A, Stalder C, Blanco MC, Ettore G, Van Calster B, Timmerman D, Bourne T. Evaluating the risk of ovarian cancer before surgery using the ADNEX model: a multicentre external validation study. Br J Cancer. 2016 Aug 23;115(5):542-8. doi: 10.1038/bjc.2016.227. Epub 2016 Aug 2. — View Citation

Sayasneh A, Kaijser J, Preisler J, Johnson S, Stalder C, Husicka R, Guha S, Naji O, Abdallah Y, Raslan F, Drought A, Smith AA, Fotopoulou C, Ghaem-Maghami S, Van Calster B, Timmerman D, Bourne T. A multicenter prospective external validation of the diagnostic performance of IOTA simple descriptors and rules to characterize ovarian masses. Gynecol Oncol. 2013 Jul;130(1):140-6. doi: 10.1016/j.ygyno.2013.04.003. Epub 2013 Apr 8. — View Citation

Schmeler KM, Mayo-Smith WW, Peipert JF, Weitzen S, Manuel MD, Gordinier ME. Adnexal masses in pregnancy: surgery compared with observation. Obstet Gynecol. 2005 May;105(5 Pt 1):1098-103. doi: 10.1097/01.AOG.0000157465.99639.e5. — View Citation

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Testa AC, Mascilini F, Quagliozzi L, Moro F, Bolomini G, Mirandola MT, Moruzzi MC, Scambia G, Fagotti A. Management of ovarian masses in pregnancy: patient selection for interventional treatment. Int J Gynecol Cancer. 2021 Jun;31(6):899-906. doi: 10.1136/ijgc-2020-001996. Epub 2020 Nov 10. — View Citation

Timmerman D, Ameye L, Fischerova D, Epstein E, Melis GB, Guerriero S, Van Holsbeke C, Savelli L, Fruscio R, Lissoni AA, Testa AC, Veldman J, Vergote I, Van Huffel S, Bourne T, Valentin L. Simple ultrasound rules to distinguish between benign and malignant adnexal masses before surgery: prospective validation by IOTA group. BMJ. 2010 Dec 14;341:c6839. doi: 10.1136/bmj.c6839. — View Citation

Timmerman D, Testa AC, Bourne T, Ameye L, Jurkovic D, Van Holsbeke C, Paladini D, Van Calster B, Vergote I, Van Huffel S, Valentin L. Simple ultrasound-based rules for the diagnosis of ovarian cancer. Ultrasound Obstet Gynecol. 2008 Jun;31(6):681-90. doi: 10.1002/uog.5365. — View Citation

Timmerman D, Testa AC, Bourne T, Ferrazzi E, Ameye L, Konstantinovic ML, Van Calster B, Collins WP, Vergote I, Van Huffel S, Valentin L; International Ovarian Tumor Analysis Group. Logistic regression model to distinguish between the benign and malignant adnexal mass before surgery: a multicenter study by the International Ovarian Tumor Analysis Group. J Clin Oncol. 2005 Dec 1;23(34):8794-801. doi: 10.1200/JCO.2005.01.7632. — View Citation

Timmerman D, Van Calster B, Jurkovic D, Valentin L, Testa AC, Bernard JP, Van Holsbeke C, Van Huffel S, Vergote I, Bourne T. Inclusion of CA-125 does not improve mathematical models developed to distinguish between benign and malignant adnexal tumors. J Clin Oncol. 2007 Sep 20;25(27):4194-200. doi: 10.1200/JCO.2006.09.5943. Epub 2007 Aug 13. — View Citation

Timmerman D, Van Calster B, Testa A, Savelli L, Fischerova D, Froyman W, Wynants L, Van Holsbeke C, Epstein E, Franchi D, Kaijser J, Czekierdowski A, Guerriero S, Fruscio R, Leone FPG, Rossi A, Landolfo C, Vergote I, Bourne T, Valentin L. Predicting the risk of malignancy in adnexal masses based on the Simple Rules from the International Ovarian Tumor Analysis group. Am J Obstet Gynecol. 2016 Apr;214(4):424-437. doi: 10.1016/j.ajog.2016.01.007. Epub 2016 Jan 19. — View Citation

Timmerman D, Van Calster B, Testa AC, Guerriero S, Fischerova D, Lissoni AA, Van Holsbeke C, Fruscio R, Czekierdowski A, Jurkovic D, Savelli L, Vergote I, Bourne T, Van Huffel S, Valentin L. Ovarian cancer prediction in adnexal masses using ultrasound-based logistic regression models: a temporal and external validation study by the IOTA group. Ultrasound Obstet Gynecol. 2010 Aug;36(2):226-34. doi: 10.1002/uog.7636. — View Citation

Van Calster B, Timmerman D, Bourne T, Testa AC, Van Holsbeke C, Domali E, Jurkovic D, Neven P, Van Huffel S, Valentin L. Discrimination between benign and malignant adnexal masses by specialist ultrasound examination versus serum CA-125. J Natl Cancer Inst. 2007 Nov 21;99(22):1706-14. doi: 10.1093/jnci/djm199. Epub 2007 Nov 13. — View Citation

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* Note: There are 47 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Change in the ultrasound appearance of endometriomas during gestation; Change in the ultrasound appearance of endometriomas during gestation; outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
Other - Occurrence of complications such as rupture, torsion, or malignancy during pregnancy in patients with conservatively treated masses (cumulative incidence illustrated by 'reverse' Kaplan-Meier curves). - Occurrence of complications such as rupture, torsion, or malignancy during pregnancy in patients with conservatively treated masses (cumulative incidence illustrated by 'reverse' Kaplan-Meier curves). outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
Other - Comparison of the performance of ADNEX with CA125 and that of ADNEX without CA125. (Specificity, Sensitivity, C-index, Calibration, Clinical Utility) outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
Primary - Estimation of the false discovery rate when the ADNEX Model is applied at 11-14 weeks. - Estimation of the false discovery rate when the ADNEX Model is applied at 11-14 weeks. outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
Secondary - Estimation of the false discovery rate when the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) is applied at 11-14 weeks. - Estimation of the false discovery rate when the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) is applied at 11-14 weeks. outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
Secondary - Estimation of the false discovery rate when the ADNEX Model and the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) are applied at any time point during pregnancy; - Estimation of the false discovery rate when the ADNEX Model and the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) are applied at any time point during pregnancy; outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
Secondary Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at 11-14 weeks gestation. C-index outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
Secondary Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at 11-14 weeks gestation. (Sensitivity, Specificity) outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
Secondary Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at 11-14 weeks gestation. (Calibration) outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
Secondary Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at 11-14 weeks gestation. (Clinical utility) Net benefit. outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
Secondary Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at any time point in pregnancy. (C-index) outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
Secondary Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at any time point in pregnancy. (Sensitivity, Specificity) outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
Secondary Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at any time point in pregnancy. (Calibration) outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
Secondary Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at any time point in pregnancy. (Clinical utility) Net benefit. outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
Secondary - Estimation of the ability of the ADNEX model and the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at any time po - Estimation of the ability of the ADNEX model and the 2-step strategy (sensitivity, specificity, C-index, calibration intercept, calibration slope, clinical utility) to discriminate between benign and malignant adnexal masses when detected at any time point in pregnancy; outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
Secondary Evaluation of change in morphology of ovarian masses throughout pregnancy based on subjective assessment; Evaluation of change in morphology of ovarian masses throughout pregnancy based on subjective assessment; outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
Secondary Evaluation of change throughout pregnancy and postpartum in papillations based on subjective assessment. Number, size (mm), colour score (1-4), and morphology. outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
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