NCT06320418

Brief Summary

Ovarian cancer (OC) has one of the highest mortality rates for female malignant tumors, attributed to advanced cancer stages upon diagnosis as well as a high recurrence rate. Piwi-interacting RNA-823 (piR-823) is a single-stranded non-protein coding RNA (ncRNA) star molecule in epigenetics research. Extensive cellular regulatory functions and aberrant expression of piR-823 have been implicated in carcinogenesis. Therefore, the findings of piwi-ncRNA dysregulated-expression in OC Egyptian female patients' cohort could be employed as a potential novel mechanism for OC precision, a step toward ncRNA-precision

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

June 15, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

1.5 years

First QC Date

February 22, 2024

Last Update Submit

March 17, 2024

Conditions

Keywords

piR-823, Ovarian cancer, DNA methylation

Outcome Measures

Primary Outcomes (1)

  • Association of piR-823 expression with ovarian cancer progression

    Investigating the expression of piR-823 in ovarian cancer tissue samples using qRT-PCR.

    18 months

Study Arms (2)

Patients group

A total of 39 female patients in their age range (13-75 years) diagnosed with primary malignant ovarian tumors were enrolled in the study. OC patients were a treatment-naïve Egyptian patients' cohort admitted to the Gynecology and Obstetrics Department or the Oncology Dept., Ain Shams University Hospitals, Cairo, Egypt. Ovarian cancer tissue samples were collected during surgical resection and confirmed by postoperative pathological examinations.

Control group

A total of 17 normal ovarian tissue samples were collected from patients with benign uterine diseases, such as myoma, who underwent uterine and ovarian resection. The control's age range is 45-62 years

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsstudy of ovarian cancer
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patient enrolled in the study if they met the inclusion criteria and, after giving their approval for participation in the study, signed the informed consent.

You may qualify if:

  • Newly diagnosed patients
  • Untreated cases of patients
  • Histopathologically confirmed OC patients

You may not qualify if:

  • Individuals receiving chemotherapy, and radiation
  • Patients with a history of other cancers other than ovarian cancer
  • Individuals with inadequate data or missing histopathological diagnoses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab

Cairo, 11566, Egypt

Location

Related Publications (1)

  • References [1] R. Jiang et al., "Inhibition of long non-coding RNA XIST upregulates microRNA-149-3p to repress OC cell progression," Cell Death Dis., vol. 12, no. 2, p. 145, Feb. 2021, doi: 10.1038/s41419-020-03358-0. [3] E. Lee, N. A. Lokman, et al. "A Comprehensive Molecular and Clinical Analysis of the piRNA Pathway Genes in OC," Cancers (Basel)., vol. 13, no. 1, p. 4, Dec. 2020, doi: 10.3390/cancers13010004. [4] K. Wang, T. Wang, X. Gao, X. Chen, F. Wang, and L. Zhou, "Emerging functions of piwi-interacting RNAs in diseases," J. Cell. Mol. Med., vol. 25, no. 11, pp. 4893-4901, Jun. 2021, doi: 10.1111/jcmm.16466. [5] G. Singh, J. Roy, P. Rout, and B. Mallick, "Genome-wide profiling of the PIWI-interacting RNA-mRNA regulatory networks in epithelial OCs," PLoS One, vol. 13, no. 1, p. e0190485, Jan. 2018, doi: 10.1371/journal.pone.0190485. [6] N. A. Sabbah et al., "piRNA-823 Is a Unique Potential Diagnostic Non-Invasive Biomarker in Colorectal Cancer Patients," Genes (Basel)., vol. 12, no. 4, p. 598, Apr. 2021, doi: 10.3390/genes12040598. [7] J.-F. Su et al., "piR-823 demonstrates tumor oncogenic activity in esophageal squamous cell carcinoma through DNA methylation induction via DNA methyltransferase 3B," Pathol. - Res. Pract., vol. 216, no. 4, p. 152848, Apr. 2020, doi: 10.1016/j.prp.2020.152848.

    BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Ovarian fresh tissue samples were collected from the controls, and OC patients underwent surgical resection at the Department of Obstetrics and Gynecology, Ain Shams University. All resected tissue samples were stored at -20°C after adding RNA Stabilization Reagent

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

Study Officials

  • Nadia Hamdy, PhD

    faculty of pharmacy Ain Shams university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of Biochemistry and molecular biology

Study Record Dates

First Submitted

February 22, 2024

First Posted

March 20, 2024

Study Start

June 15, 2022

Primary Completion

December 10, 2023

Study Completion

June 1, 2024

Last Updated

March 20, 2024

Record last verified: 2024-03

Locations