NCT05496517

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 11, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2023

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

9 months

First QC Date

August 9, 2022

Last Update Submit

August 9, 2022

Conditions

Keywords

ovarian neoplasm

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Recurrence-free survival (RFS) rate at 5 years

    Within 5 years of diagnosis of ovarian cancer

  • Recurrence-free survival (RFS) rate at 3 years

    Within 3 years of diagnosis of ovarian cancer

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All women who will be diagnosed with primary ovarian cancer at any stage, of all histological types and grades eligible for the study

You may qualify if:

  • 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

You may not qualify if:

  • Inadequate information and follow-up for at least 5 years.
  • Authorization to use anonymous patient data for research purposes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alexandria University Main Hospital

Alexandria, 21516, Egypt

Location

Assiut Hospitals university

Asyut, 71511, Egypt

Location

Related Publications (10)

  • 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.

    PMID: 33538338BACKGROUND
  • Caan BJ, Thomson CA. Breast and ovarian cancer. Optim Women's Heal through Nutr. Published online 2007:229-263. doi:10.1369/0022155411428469

    BACKGROUND
  • 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

    BACKGROUND
  • Jacobs IJ, Menon U. Progress and challenges in screening for early detection of ovarian cancer. Mol Cell Proteomics. 2004 Apr;3(4):355-66. doi: 10.1074/mcp.R400006-MCP200. Epub 2004 Feb 5.

    PMID: 14764655BACKGROUND
  • 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. doi: 10.1001/jama.291.22.2705.

    PMID: 15187051BACKGROUND
  • 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. doi: 10.1016/j.ygyno.2007.06.006. Epub 2007 Jul 27.

    PMID: 17662378BACKGROUND
  • 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.

    PMID: 31118829BACKGROUND
  • 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.

    PMID: 32241876BACKGROUND
  • 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.

    PMID: 31188324BACKGROUND
  • McCorkle R, Pasacreta J, Tang ST. The silent killer: psychological issues in ovarian cancer. Holist Nurs Pract. 2003 Nov-Dec;17(6):300-8. doi: 10.1097/00004650-200311000-00005.

    PMID: 14650572BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 11, 2022

Study Start

November 11, 2022

Primary Completion

August 11, 2023

Study Completion

November 22, 2023

Last Updated

August 11, 2022

Record last verified: 2022-08

Locations