NCT06777082Recruiting
Role of RPL8 Protein Alterations in High-grade Serous Ovarian Carcinoma
Ruolo Delle Alterazioni Della Proteina RPL8 Nel Carcinoma Ovarico Sieroso ad Alto Grado
Source: ClinicalTrials.gov · Last updated 15 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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: 1. The relationship between the genetic status of RPL8 and clinical outcomes. 2. The contribution of RPL8 amplification to treatment response. Type of human tissue under study: The analyses will be conducted on tumor tissue samples obtained from ovarian cancer resections. Some samples have already been collected and stored at the IRCCS, while others are yet to be gathered. Type of investigation: * 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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 10 Jan 2025
- Start date
- 20 Mar 2024
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Diseases
- Ovarian cancer
- NCT number
- NCT06777082
What you commit to
- Study type: Observational
- Planned participants: 150
- From 20 Mar 2024 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Ovarian tumors of histological types other than serous.
- Other primary tumor types.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Azianda Ospedaliero-Universitaria di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.