NCT05697601

Brief Summary

The goal of this observational study is to explore the possible associated factors of ovarian cancer and endometrial cancer in Indonesia and develop screening tools that could predict the risk of both types of cancer The specific objectives of the study are

  1. 1.Elaborating the situation of ovarian and endometrial cancer in Indonesia
  2. 2.Exploring the possible clinical, demography and laboratory predictors of these diseases
  3. 3.Develop artificial-intelligence-based screening tools for both type of cancer based on possible predictors

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
2,905

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

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

January 14, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

January 14, 2023

Last Update Submit

November 24, 2023

Conditions

Keywords

Ovarian CancerEndometrial CancerEndometrial HyperplasiaArtificial IntelligencePoint of Care TestingStagingGynecological ScreeningPathology

Outcome Measures

Primary Outcomes (2)

  • Number of People developing ovarian cancer

    Number of people developing ovarian cancer diagnosed with gynaecology and pathology assessment

    from baseline to twelve month after entering cohort

  • Number of People developing endometrial cancer

    Number of people developing endometrial cancer diagnosed with gynaecology and pathology assessment

    from baseline to twelve month after entering cohort

Secondary Outcomes (1)

  • Screening Performance of Artificial-Intelligence-based Screening tools

    from baseline assessment up to one year

Study Arms (3)

Suspect of Ovarian Cancer

The participant with high suspicion of ovarian cancer and undergo gynaecology and pathology assessment

Diagnostic Test: Artificial-Intelligence Based Screening ToolsDiagnostic Test: Pathology analysis

Suspect of Endometrial Cancer

The participant with high suspicion of Endometrial cancer (and or endometrial hyperplasia) and undergo gynaecology and pathology assessment

Diagnostic Test: Artificial-Intelligence Based Screening ToolsDiagnostic Test: Pathology analysis

Normal Cohort

The participant with lower suspicion of both types of cancer and undergo gynaecology and pathology assessment

Diagnostic Test: Artificial-Intelligence Based Screening ToolsDiagnostic Test: Pathology analysis

Interventions

Artificial-Intelligence Based Screening Tools build on machine learning models

Normal CohortSuspect of Endometrial CancerSuspect of Ovarian Cancer
Pathology analysisDIAGNOSTIC_TEST

Pathology assessment of cells and tissues from respective organs

Normal CohortSuspect of Endometrial CancerSuspect of Ovarian Cancer

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsas the disease affects natural-born women, therefore, only women will be included
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

As this study is utilizing a patient registry, we will involve all eligible participants who undergo gynaecological and pathology assessment for ovarian and endometrial cancer in study centres, based on suggestive signs and symptoms

You may qualify if:

  • Women with gynaecological symptoms but not limited to
  • Irregular menstruation
  • Heavy bleeding during menstruation
  • pelvic pain
  • vaginal discharge
  • sudden weight loss
  • pain during sexual intercourse
  • Women who underwent routine gynaecological examination

You may not qualify if:

  • unable to undergo serial gynaecological follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasanuddin University Hospital

Makassar, South Sulawesi, 90245, Indonesia

RECRUITING

Related Publications (6)

  • Atallah GA, Abd Aziz NH, Teik CK, Shafiee MN, Kampan NC. New Predictive Biomarkers for Ovarian Cancer. Diagnostics (Basel). 2021 Mar 7;11(3):465. doi: 10.3390/diagnostics11030465.

    PMID: 33800113BACKGROUND
  • Elias KM, Guo J, Bast RC Jr. Early Detection of Ovarian Cancer. Hematol Oncol Clin North Am. 2018 Dec;32(6):903-914. doi: 10.1016/j.hoc.2018.07.003. Epub 2018 Sep 28.

    PMID: 30390764BACKGROUND
  • Tanha K, Mottaghi A, Nojomi M, Moradi M, Rajabzadeh R, Lotfi S, Janani L. Investigation on factors associated with ovarian cancer: an umbrella review of systematic review and meta-analyses. J Ovarian Res. 2021 Nov 11;14(1):153. doi: 10.1186/s13048-021-00911-z.

    PMID: 34758846BACKGROUND
  • Zhao J, Hu Y, Zhao Y, Chen D, Fang T, Ding M. Risk factors of endometrial cancer in patients with endometrial hyperplasia: implication for clinical treatments. BMC Womens Health. 2021 Aug 25;21(1):312. doi: 10.1186/s12905-021-01452-9.

    PMID: 34433451BACKGROUND
  • Felix AS, Weissfeld JL, Stone RA, Bowser R, Chivukula M, Edwards RP, Linkov F. Factors associated with Type I and Type II endometrial cancer. Cancer Causes Control. 2010 Nov;21(11):1851-6. doi: 10.1007/s10552-010-9612-8. Epub 2010 Jul 14.

    PMID: 20628804BACKGROUND
  • Herman B, Sirichokchatchawan W, Pongpanich S, Nantasenamat C. Development and performance of CUHAS-ROBUST application for pulmonary rifampicin-resistance tuberculosis screening in Indonesia. PLoS One. 2021 Mar 25;16(3):e0249243. doi: 10.1371/journal.pone.0249243. eCollection 2021.

    PMID: 33765092BACKGROUND

MeSH Terms

Conditions

Ovarian NeoplasmsEndometrial NeoplasmsEndometrial Hyperplasia

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 DisordersUterine NeoplasmsUterine Diseases

Study Officials

  • Rina Masadah, Ph.D

    Hasanuddin University

    STUDY CHAIR
  • Bumi Herman, Ph.D

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bumi Herman, Ph.D

CONTACT

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

January 14, 2023

First Posted

January 26, 2023

Study Start

February 28, 2023

Primary Completion

February 28, 2024

Study Completion

June 30, 2024

Last Updated

November 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

The individual participant data will be shared after de-identification and the purpose of the data utilization is verified by the investigators

Locations