Ovarian Cancer Individualized Scoring System Scoring System

Ovarian Cancer Clinical Trial

— OCISS  

Official title:

Ovarian Cancer Individualized Scoring System (OCISS) for Prediction of Ovarian Cancer Prognosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05496517
• Other study ID #: MOGGE-GO03
• Status: Not yet recruiting
• Start date: November 11, 2022
• Est. completion date: November 22, 2023

Study information

• Verified date: August 2022
• Source: Assiut University
• Contact: Sherif Shazly
• Phone: +4407554480388
• Email: sherif.shazly.mogge[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This project aims at creating an individualized prognostic model using patient characteristics and disease features to determine disease prognosis using machine learning technology. The model can be used to determine the optimal management plan per patient in priori and highlight risk and timing of disease recurrence.

Description:

Ovarian cancer (OC) is one of the most common types of malignant tumors and the eighth cause of cancer-related mortality in women.[1] Among gynecological cancers, it is ranked the third following cervical and uterine cancers and is associated with the worst prognosis

[1]. Globally, there are 313,959 new cases and 207,252 deaths of OC annually [1].

Compared to breast cancer, OC is approximately three times more lethal [2]. The high mortality rate of OC is attributed to the capacious anatomical space through which the tumor can grow before it causes significant symptoms, growth of the tumor within abdominal cavity rendering spread of malignant cells widespread and prompt, direct lymphatic drainage to aortic lymph nodes, lack of specific diagnostic symptoms, and unavailability of an efficient screening strategy [3,4]. Symptoms of OC are nonspecific and include vague abdominal pain, abdominal bloating, urinary frequency, early satiety, feeling full, or changes in bowel habits, most of which mimic common gastrointestinal symptoms [5]. Risk factors of OC include obesity, old age, smoking, genetic predisposition, and endometriosis [6,7]. FIGO staging is considered the standard classification system that determines prognosis and management of newly diagnosed OC. However, there are numerous gaps in this staging system that would limit interpretation of clinically relevant data [8]. For instance, the staging system does not consider crucial disease prognostic factors, such as histological type and grade, which are usually considered separately based on available evidence and internal policies. This multi-layer guidance adds to the complexity of decision making. Similarly, personalized management is overlooked since these staging systems do not appreciate individual characteristics such as age, menopausal states, comorbidities, and genetic predisposition. All patients with positive lymph nodes are grouped into a single stage in FIGO staging system, which creates a very diverse group of patients with highly variable survival rates [9]. Management of ovarian cancer is surgical and comprises bilateral sapling-oophorectomy, total abdominal hysterectomy , and infracolic omentectomy. Additional surgical steps and neoadjuvant therapy are potentially determined by disease characteristics. Extent of surgery and neoadjuvant treatment is directly related to postoperative comorbidities and contributes to long term prognosis.

[10]. Therefore, development of an individualized prognostic and decision-making system, based on large multicenter studies, would facilitate accurate prediction of disease prognosis and determination of individualized management strategy.

The study will comprise at least 8 international cancer centers. Data of patients, newly diagnosed with OC between January 2010 and December 2016, will be retrospectively collected. Therefore, a follow-up of at least 5 years would be granted. All women who will be diagnosed with primary ovarian cancer at any stage, of all histological types and grades eligible for the study. All contributing centers should acquire institutional review board (IRB) approval prior to data collection.

Inclusion criteria:

• Women diagnosed with ovarian cancer between January 2010 and December 2016.

• Primary non-recurrent diagnosis of ovarian cancer.

• Women should be diagnosed and managed by the corresponding center.

• Patients with adequate clinical and pathological data

Exclusion criteria:

• Inadequate information and follow-up for at least 5 years.

• Authorization to use anonymous patient data for research purposes. Data will be collected using an excel spreadsheet designed for this study and shared among contributing centers. Data include patients' demographics such as age, parity, body mass index, ethnicity, smoking index, contraception method, menopausal status, medical comorbidities [coronary artery disease, diabetes on insulin, hypertension, chronic renal 3 disease, chronic lung disease, thyroid dysfunction], preoperative imaging [cancer stage, involvement of ovaries, surface involvement, uterine involvement, tubal involvement, inguinal lymph nodes (number, largest diameter), extra abdominal lymph nodes (size and enlargement), abdominal invasion (omental deposits > 2cm, peritoneal carcinomatosis), other pelvic invasion], positive cytology, grade (high/low), pleural effusion and cytology, ascites, performance status, histological type, biomarkers, BRCA I and II (germline or somatic), and serum albumin level. Details of management plan will be collected including treatment approach [Time from diagnosis to surgery, Surgical approach, PA lymphadenectomy (systematic, selective, none)], chemotherapy [systematic or intraperitoneal], and other treatments given.

Treatment outcomes such as complications, debulking success, spill, nodal metastasis, microscopic peritoneal metastasis, microscopic omental metastasis, response to chemotherapy, and CA 125 changes will be included. Data will not include any identifiable information.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: November 22, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Women diagnosed with ovarian cancer between January 2010 and December 2016.

• Primary non-recurrent diagnosis of ovarian cancer.

• Women should be diagnosed and managed by the corresponding center.

• Patients with adequate clinical and pathological data

Exclusion Criteria:

• • Inadequate information and follow-up for at least 5 years.

• Authorization to use anonymous patient data for research purposes.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
Egypt	Alexandria University Main Hospital	Alexandria
Egypt	Assiut Hospitals university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

Caan BJ, Thomson CA. Breast and ovarian cancer. Optim Women's Heal through Nutr. Published online 2007:229-263. doi:10.1369/0022155411428469

Goff BA, Mandel LS, Melancon CH, Muntz HG. Frequency of symptoms of ovarian cancer in women presenting to primary care clinics. JAMA. 2004 Jun 9;291(22):2705-12. — View Citation

Jacobs IJ, Menon U. Progress and challenges in screening for early detection of ovarian cancer. Mol Cell Proteomics. 2004 Apr;3(4):355-66. Epub 2004 Feb 5. Review. — View Citation

Jordan SJ, Green AC, Whiteman DC, Webb PM; Australian Ovarian Cancer Study Group. Risk factors for benign, borderline and invasive mucinous ovarian tumors: epidemiological evidence of a neoplastic continuum? Gynecol Oncol. 2007 Nov;107(2):223-30. Epub 2007 Jul 27. — View Citation

McCorkle R, Pasacreta J, Tang ST. The silent killer: psychological issues in ovarian cancer. Holist Nurs Pract. 2003 Nov-Dec;17(6):300-8. Review. — View Citation

Momenimovahed Z, Tiznobaik A, Taheri S, Salehiniya H. Ovarian cancer in the world: epidemiology and risk factors. Int J Womens Health. 2019 Apr 30;11:287-299. doi: 10.2147/IJWH.S197604. eCollection 2019. — View Citation

Salvo G, Odetto D, Pareja R, Frumovitz M, Ramirez PT. Revised 2018 International Federation of Gynecology and Obstetrics (FIGO) cervical cancer staging: A review of gaps and questions that remain. Int J Gynecol Cancer. 2020 Jun;30(6):873-878. doi: 10.1136/ijgc-2020-001257. Epub 2020 Apr 1. Review. — View Citation

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. — View Citation

Urban N. Early detection of ovarian cancer: Methodological considerations. Int J Gynecol Obstet. 2000;70:D9-D9. doi:10.1016/s0020-7292(00)82512-6

Wright JD, Matsuo K, Huang Y, Tergas AI, Hou JY, Khoury-Collado F, St Clair CM, Ananth CV, Neugut AI, Hershman DL. Prognostic Performance of the 2018 International Federation of Gynecology and Obstetrics Cervical Cancer Staging Guidelines. Obstet Gynecol. 2019 Jul;134(1):49-57. doi: 10.1097/AOG.0000000000003311. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer-specific survival (CSS) rate at 5 years	Percentage of women newly diagnosed with ovarian cancer who do not die from ovarian cancer after 5 years	Within 5 years after diagnosis of ovarian cancer
Primary	Cancer-specific survival (CSS) rate at 3 years	Percentage of women newly diagnosed with ovarian cancer who do not die from ovarian cancer after 3 years	Within 3 years after diagnosis of ovarian cancer
Secondary	Recurrence-free survival (RFS) rate at 5 years	Percentage of newly diagnosed women who do not experience disease recurrence during follow-up	Within 5 years of diagnosis of ovarian cancer
Secondary	Recurrence-free survival (RFS) rate at 3 years	Percentage of newly diagnosed women who do not experience disease recurrence during follow-up	Within 3 years of diagnosis of ovarian cancer