High Grade Serous Ovarian CancerOVCARNCT06777082
Role of RPL8 Protein Alterations in High-grade Serous Ovarian Carcinoma
An observational study of High Grade Serous Ovarian Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Grade Serous Ovarian Cancer
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2024to 30 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women affected with high grade serous ovarian cancer matching the inclusion criteria
Who may be able to join
- 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.
Who cannot join
- Ovarian tumors of histological types other than serous.
- Other primary tumor types.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azianda Ospedaliero-Universitaria di Bologna
Bologna, BO, 40138
Lorenzo Montanaro, MD, +390512144524, lorenzo.montanaro@aosp.bo.it
About this study
Official title: Ruolo Delle Alterazioni Della Proteina RPL8 Nel Carcinoma Ovarico Sieroso ad Alto Grado
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.
Read more
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:
- The relationship between the genetic status of RPL8 and clinical outcomes.
- 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.
Read the detailed description
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:
- The relationship between the genetic status of RPL8 and clinical outcomes.
- 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.
General characteristics of the study population:
Inclusion criteria:
- 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.
Exclusion criteria:
- Ovarian tumors of histological types other than serous.
- Other primary tumor types.
Study Design retrospective (on archival material) + prospective
- Conditions
- High Grade Serous Ovarian Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
RPL8 status
RPL8 gene copy number and expression
Measured: 2 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start20 Mar 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade Serous Ovarian CancerStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenzo Montanaro, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777082
- Sponsor's protocol ID
- OVCAR
- Other IDs
- RC-22000593
- Acronym
- OVCAR
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ruolo Delle Alterazioni Della Proteina RPL8 Nel Carcinoma Ovarico Sieroso ad Alto Grado
- ClinicalTrials.gov ID
- NCT06777082
- Acronym / sponsor ID
- OVCAR / OVCAR
- Conditions
- High Grade Serous Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The relationship between the genetic status of RPL8 and clinical outcomes.
- 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.
Detailed description
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:
- The relationship between the genetic status of RPL8 and clinical outcomes.
- 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.
General characteristics of the study population:
Inclusion criteria:
- 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.
Exclusion criteria:
- Ovarian tumors of histological types other than serous.
- Other primary tumor types.
Study Design retrospective (on archival material) + prospective
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women affected with high grade serous ovarian cancer matching the inclusion criteria
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Ovarian tumors of histological types other than serous.
- Other primary tumor types.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RPL8 status
Time frame: 2 years after enrollment
RPL8 gene copy number and expression
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma
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RecruitingPhase 1
Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorenzo Montanaro, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Grade Serous Ovarian Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Montanaro, MD (+390512144524, lorenzo.montanaro@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RPL8 status (time frame: 2 years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.