Role of RPL8 Protein Alterations in High-grade Serous Ovarian Carcinoma

NCT06777082 | Recruiting

• 2 other identifiers: OVCARRC-22000593
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Background and rationale of the study: From our preliminary analyses of a dataset on patients with high-grade serous ovarian carcinoma (HGSOC), available in the online database The Cancer Genome Atlas, we found that the gene encoding ribosomal protein L8 (RPL8) is amplified at a high frequency (\~30%) in HGSOC. Moreover, its mRNA expression is positively correlated with its genetic amplification-an observation not previously reported or studied in the literature. RPL8 is a structural component of the large ribosomal subunit, which is involved in protein synthesis. Based on this, and our preliminary data, we hypothesize that RPL8 amplification may play a role in ovarian cancer development. Understanding the impact of RPL8 amplification in ovarian cancer could provide new insights into the biology of this poorly understood cancer. Study objectives: The main objective of this project is to determine whether RPL8 can be used as a biomarker both for risk assessment and for patient stratification in choosing the most appropriate therapeutic option. Specifically, we aim to study:

• Expression analysis of RPL8, C-MYC, and related genes (RT-PCR, ddPCR, WB, IHC).
• Gene copy number analysis and mutation screening (ddPCR and similar molecular techniques).
• Analysis of possible associations between pathological data, follow-up data, and therapeutic response outcomes in patients. Analysis methodology: Data on the genetic status, expression, and subcellular localization of RPL8 and C-MYC will be correlated with categorical and continuous variables related to the patients' medical history and clinical status. Differences between categorical variables will be analyzed using analysis of variance (ANOVA), the Mann-Whitney test, or the Kruskal-Wallis test, depending on whether data distribution is normal or not (assessed via the Kolmogorov-Smirnov test). Correlations between continuous variables will be evaluated using Pearson or Spearman tests, again based on data distribution.

Conditions

High Grade Serous Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• RPL8 status

  RPL8 gene copy number and expression

  2 years after enrollment

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women affected with high grade serous ovarian cancer matching the inclusion criteria

You may qualify if:

• Age ≥ 18 years.
• Diagnosis of high-grade (3 or 4) serous ovarian carcinoma, either at onset or recurrence.
• Signed informed consent to participate in the study.

You may not qualify if:

• Ovarian tumors of histological types other than serous.
• Other primary tumor types.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azianda Ospedaliero-Universitaria di Bologna

Bologna, BO, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA from post operators tissue specimen will be extracted for RPL8 \& MYC status evaluation

Study Officials

• Lorenzo Montanaro, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Montanaro, MD

CONTACT

+390512144524; lorenzo.montanaro@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: March 20, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 30, 2025
• Last Updated: January 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)