Ovarian CancerNCT06553742
High Definition Profiling of Ovarian Cancer Ascites
An observational study of Ovarian Cancer and High Grade Ovarian Serous Adenocarcinoma, run by European Institute of Oncology at 1 site in Italy.
Trial summary
This project entails the collection of a prospective cohort of ascites (AS) samples from High Grade Serous Ovarian Cancer (HGSOC) patients. High Grade Serous Ovarian Cancer (HGSOC) is a major cause of cancer-related mortality, due to the late-stage diagnosis and failure of surgery and chemotherapy (CHT) to eradicate… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, High Grade Ovarian Serous Adenocarcinoma, Ascites
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2024to Dec 2033
- 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
- Adult, Older adult
Study population: HGSOC samples are provided by the European Institute of Oncology biobank. All patients will be provided written informed consent. Patients with suspicious or confirmed ovarian cancer pathology undergoing debulking surgery will be included in the protocol. Only samples diagnosed as high grade serous ovarian cancer confirmed by histopathology assessment will be included in the following analyses.
Who may be able to join
- Patients with suspicious or confirmed ovarian cancer pathology undergoing debulking surgery
- Diagnosis of high grade serous ovarian cancer confirmed by histopathology assessment
- Patients who provided written informed consent
Who cannot join
- HIV-positive patients
- HBV-positive patients
- HCV-positive patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pietro Lo Riso contact
About this study
Official title: High Definition Profiling of Ovarian Cancer Ascites for the Identification of Prognostic Biomarkers and Immunotherapeutic Targets: an Integrative Cell of Origin-guided Approach
This project entails the collection of a prospective cohort of ascites (AS) samples from High Grade Serous Ovarian Cancer (HGSOC) patients.
High Grade Serous Ovarian Cancer (HGSOC) is a major cause of cancer-related mortality, due to the late-stage diagnosis and failure of surgery and chemotherapy (CHT) to eradicate the disease with no significant improvement in overall survival.
The primary objective of the project is to generate a comprehensive map of ascites cell components, detailing both their intrinsic features and the landscape of cellular interactions mediated by soluble factors in ascitic fluid.
Read the detailed description
HGSOC is a major cause of cancer-related mortality, due to the late-stage diagnosis and failure of surgery and chemotherapy (CHT) to eradicate the disease with no significant improvement in overall survival.
In recent years, new therapeutic regimens are being tested to improve the care of HGSOC patients. These approaches include the use of poly-ADP-ribose polymerase inhibitors (PARPi) targeting Homology Directed Repair deficiency, anti-angiogenic drugs, such as anti-VEGF monoclonal antibodies, and immune checkpoint inhibitors, that target immune modulation induced by tumor and tumor-associated cells and inflammatory signals. Unfortunately, the outcome of such therapies has been to date either erratic or dismal.
This points to the acute need to identify new biomarkers predictive of treatment response, effectively geared to the clinical setting.
The primary objective of the project is to generate a comprehensive map of ascites cell components, detailing both their intrinsic features and the landscape of cellular interactions mediated by soluble factors in ascitic fluid. This will allow to define tumoral archetypes, reflecting HGSOC's endophenotypes, associated with prognosis in patients, possibly guiding future refined therapeutical paradigms for ovarian cancer patients and endowing researchers with a well-characterized multilayered dataset for future reference in the context of molecular dissection and target discovery paradigms.
Indeed, the combination of origin- and archetype-based stratification of HGSOC patients, will allow to better identify patients for which existing therapeutical regimens could be beneficial, such as the use of checkpoint inhibitors and anti-angiogenic drugs, that have been so far erratic in ameliorating patient's survival.
- Medical subject headings
- Ovarian Neoplasms, Ascites
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation of a comprehensive map of ascites cell components
The samples will be stratified according to a DNA-methylation based signature specific for the tissue of origin of HGSOC.
The cellular fraction derived from ascites samples will be profiled by single cell multiomics to define the cell populations associated to either the fallopian tube or ovarian surface epithelium origin. In parallel, ascitic fluid will be profiled by ELISA to define the soluble components present in the two HGSOC subtypes. These data will be used to generate a map of ascites cell components and biomarkers specific for the two tissues of origin of this disease. This map will be exploited to highlight possible therapeutic avenues for HGSOC patients.
Measured: 48 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study startNov 2024 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Testa, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553742
- Sponsor's protocol ID
- L2-016
- Status last verified
- Jul 2024
- First submitted
- 12 Aug 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Definition Profiling of Ovarian Cancer Ascites for the Identification of Prognostic Biomarkers and Immunotherapeutic Targets: an Integrative Cell of Origin-guided Approach
- ClinicalTrials.gov ID
- NCT06553742
- Acronym / sponsor ID
- L2-016
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 14 Aug 2024 (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.
This project entails the collection of a prospective cohort of ascites (AS) samples from High Grade Serous Ovarian Cancer (HGSOC) patients.
High Grade Serous Ovarian Cancer (HGSOC) is a major cause of cancer-related mortality, due to the late-stage diagnosis and failure of surgery and chemotherapy (CHT) to eradicate the disease with no significant improvement in overall survival.
The primary objective of the project is to generate a comprehensive map of ascites cell components, detailing both their intrinsic features and the landscape of cellular interactions mediated by soluble factors in ascitic fluid.
Detailed description
HGSOC is a major cause of cancer-related mortality, due to the late-stage diagnosis and failure of surgery and chemotherapy (CHT) to eradicate the disease with no significant improvement in overall survival.
In recent years, new therapeutic regimens are being tested to improve the care of HGSOC patients. These approaches include the use of poly-ADP-ribose polymerase inhibitors (PARPi) targeting Homology Directed Repair deficiency, anti-angiogenic drugs, such as anti-VEGF monoclonal antibodies, and immune checkpoint inhibitors, that target immune modulation induced by tumor and tumor-associated cells and inflammatory signals. Unfortunately, the outcome of such therapies has been to date either erratic or dismal.
This points to the acute need to identify new biomarkers predictive of treatment response, effectively geared to the clinical setting.
The primary objective of the project is to generate a comprehensive map of ascites cell components, detailing both their intrinsic features and the landscape of cellular interactions mediated by soluble factors in ascitic fluid. This will allow to define tumoral archetypes, reflecting HGSOC's endophenotypes, associated with prognosis in patients, possibly guiding future refined therapeutical paradigms for ovarian cancer patients and endowing researchers with a well-characterized multilayered dataset for future reference in the context of molecular dissection and target discovery paradigms.
Indeed, the combination of origin- and archetype-based stratification of HGSOC patients, will allow to better identify patients for which existing therapeutical regimens could be beneficial, such as the use of checkpoint inhibitors and anti-angiogenic drugs, that have been so far erratic in ameliorating patient's survival.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- HGSOC samples are provided by the European Institute of Oncology biobank. All patients will be provided written informed consent. Patients with suspicious or confirmed ovarian cancer pathology undergoing debulking surgery will be included in the protocol. Only samples diagnosed as high grade serous ovarian cancer confirmed by histopathology assessment will be included in the following analyses.
Key inclusion criteria (3 listed)
- Patients with suspicious or confirmed ovarian cancer pathology undergoing debulking surgery
- Diagnosis of high grade serous ovarian cancer confirmed by histopathology assessment
- Patients who provided written informed consent
Key exclusion criteria (3 listed)
- HIV-positive patients
- HBV-positive patients
- HCV-positive patients
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
Generation of a comprehensive map of ascites cell components
Time frame: 48 month
The samples will be stratified according to a DNA-methylation based signature specific for the tissue of origin of HGSOC. The cellular fraction derived from ascites samples will be profiled by single cell multiomics to define the cell populations associated to either the fallopian tube or ovarian surface epithelium origin. In parallel, ascitic fluid will be profiled by ELISA to define the soluble components present in the two HGSOC subtypes. These data will be used to generate a map of ascites cell components and biomarkers specific for the two tissues of origin of this disease. This map will be exploited to highlight possible therapeutic avenues for HGSOC patients.
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 20 Nov 2024.
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
Pietro Lo Riso contact
Giuseppe Testa principal investigator
European Institute of Oncology
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 Ovarian Cancer and High Grade Ovarian Serous Adenocarcinoma, run by European Institute of Oncology 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 3 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: opening soon, as of the sponsor's last update on 20 Nov 2024. 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 Giuseppe Testa (+39 02 9437 5105, giuseppe.testa@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generation of a comprehensive map of ascites cell components (time frame: 48 month). 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 20 Nov 2024.