Ovarian CancerCO-MOULDNCT06324175
Spatial Radiogenomics of Ovarian Cancer
An observational study of Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The biological spatial and temporal heterogeneity of High Grade Serous Ovarian Carcinoma (HGSOC) severely impacts the effectiveness of therapies and is a determinant of poor outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2024to 31 Dec 2026
- 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 over 18 years old affected by HGSOC, not pregnant and not affected by other tumours
Who may be able to join
- Patients with suspected HGSOC scheduled to undergo primary debulking surgery (PDS) or interval debulking surgery (IDS) will be recruited in the study. Prior histopathological confirmation of HGSOC will be required for IDS. The PDS cases without prior histological diagnosis will be selected on the basis of clinical suspicion (elevated serum CA125 and CT imaging).
Who cannot join
- Patients less than 18 Years old
- Pregnancy
- Non-serous high grade epithelial ovarian cancer (serous low grade, mucinous, clear cell carcinoma, endometrioid or non-epithelial ovarian cancer)
- Early stage disease (I and II stage)
- CT or MRI scan not available
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
Advanced Radiology Center
Roma, 00168
Camilla Panico, MD, +390630158637
About this study
Official title: Spatial Radiogenomics of Ovarian Cancer: Implementation of a Lesion-specific 3D-printed Mould Pipeline in the Clinical Workflow for Image-guided Tissue Multi-sampling of Ovarian Tumours
The biological spatial and temporal heterogeneity of High Grade Serous Ovarian Carcinoma (HGSOC) severely impacts the effectiveness of therapies and is a determinant of poor outcomes.
Current histological evaluation is made on a single tumour sample from a single disease site per patient thus ignoring molecular heterogeneity at the whole-tumour level, key for understanding and overcoming chemotherapy resistance. Imaging can play a crucial role in the development of personalised treatments by fully capturing the disease's heterogeneity.
Read more
Radiomics quantify the image information by capturing complex patterns related to the tissue microstructure. This information can be complemented with clinical data, liquid biopsies, histological markers and genomics ("radiogenomics") potentially leading to a better prediction of treatment response and outcome. However, the extracted quantitative features usually represent the entire tumour, ignoring the spatial context.
On the other hand, radiomics-derived imaging habitats characterize morphologically distinct tumour areas and are more appropriate for monitoring the changes in the tumour microenvironment over the course of therapy. In order to successfully incorporate the habitat-imaging approach to the clinic, histological and biological validation are crucial. However, histological validation of imaging is not a trivial task, due to issues such as unmatched spatial resolution, tissue deformations, lack of landmarks and imprecise cutting. Patient-specific three-dimensional (3D) moulds are an innovative tool for accurate co-registration between imaging and histology. The aim of this study is to optimize and integrate such an automated computational 3D-mould co-registration approach in the clinical work-flow in patients with HGSOC. The validated radiomics-based tumour habitats will also be used to guide tissue sampling to decipher their underlying biology using genomics analysis and explore novel prediction markers.
- Conditions
- Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational Prospective Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation of the 3D printing pipeline in the clinical setting for recurrent HGSOC
Tumour will be segmented on the preoperative CT/MRI scan and 3D printed mould will be created from 2D images using a 3D printed machine. The 3D printed mould will be used to better oriented and analized the tumour in the surgery theatre in order to correlate anatomophathological features with Radiomics features that will be analyzed from the CT/MRI scans afterwords.
Measured: 3 years
Secondary outcomes (1)
Biological validation of spatial radiomics in HGSOC
Radiomic spatial texture analysis, such as the one shown in Figure 1B, will be used. The produced radiomics maps will then guide us in identifying the best biopsy sites, by recognizing phenotypically-distinct locations within complex tumours that are most likely to contain crucial information about diagnosis and treatment prognosis. The imaging information will then be linked to the genomic information of each distinct tumour habitat thus shedding more light on the underlying genomic heterogeneity of ovarian cancer and how it is phenotypically presented.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (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 Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camilla Panico, Dr, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324175
- Sponsor's protocol ID
- 6353
- Acronym
- CO-MOULD
- Status last verified
- Mar 2025
- First submitted
- 5 Feb 2024
- Last updated
- 13 Mar 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 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Radiogenomics of Ovarian Cancer: Implementation of a Lesion-specific 3D-printed Mould Pipeline in the Clinical Workflow for Image-guided Tissue Multi-sampling of Ovarian Tumours
- ClinicalTrials.gov ID
- NCT06324175
- Acronym / sponsor ID
- CO-MOULD / 6353
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Mar 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.
The biological spatial and temporal heterogeneity of High Grade Serous Ovarian Carcinoma (HGSOC) severely impacts the effectiveness of therapies and is a determinant of poor outcomes.
Current histological evaluation is made on a single tumour sample from a single disease site per patient thus ignoring molecular heterogeneity at the whole-tumour level, key for understanding and overcoming chemotherapy resistance. Imaging can play a crucial role in the development of personalised treatments by fully capturing the disease's heterogeneity.
Radiomics quantify the image information by capturing complex patterns related to the tissue microstructure. This information can be complemented with clinical data, liquid biopsies, histological markers and genomics ("radiogenomics") potentially leading to a better prediction of treatment response and outcome. However, the extracted quantitative features usually represent the entire tumour, ignoring the spatial context.
On the other hand, radiomics-derived imaging habitats characterize morphologically distinct tumour areas and are more appropriate for monitoring the changes in the tumour microenvironment over the course of therapy. In order to successfully incorporate the habitat-imaging approach to the clinic, histological and biological validation are crucial. However, histological validation of imaging is not a trivial task, due to issues such as unmatched spatial resolution, tissue deformations, lack of landmarks and imprecise cutting. Patient-specific three-dimensional (3D) moulds are an innovative tool for accurate co-registration between imaging and histology. The aim of this study is to optimize and integrate such an automated computational 3D-mould co-registration approach in the clinical work-flow in patients with HGSOC. The validated radiomics-based tumour habitats will also be used to guide tissue sampling to decipher their underlying biology using genomics analysis and explore novel prediction markers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Prospective Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women over 18 years old affected by HGSOC, not pregnant and not affected by other tumours
Key inclusion criteria (1 listed)
- Patients with suspected HGSOC scheduled to undergo primary debulking surgery (PDS) or interval debulking surgery (IDS) will be recruited in the study. Prior histopathological confirmation of HGSOC will be required for IDS. The PDS cases without prior histological diagnosis will be selected on the basis of clinical suspicion (elevated serum CA125 and CT imaging).
Key exclusion criteria (5 listed)
- Patients less than 18 Years old
- Pregnancy
- Non-serous high grade epithelial ovarian cancer (serous low grade, mucinous, clear cell carcinoma, endometrioid or non-epithelial ovarian cancer)
- Early stage disease (I and II stage)
- CT or MRI scan not available
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
Implementation of the 3D printing pipeline in the clinical setting for recurrent HGSOC
Time frame: 3 years
Tumour will be segmented on the preoperative CT/MRI scan and 3D printed mould will be created from 2D images using a 3D printed machine. The 3D printed mould will be used to better oriented and analized the tumour in the surgery theatre in order to correlate anatomophathological features with Radiomics features that will be analyzed from the CT/MRI scans afterwords.
1 secondary outcome
Biological validation of spatial radiomics in HGSOC
Time frame: 3 years
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 13 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Camilla Panico, Dr principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 1 inclusion and 5 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 13 Mar 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 Camilla Panico, Dr. (+390630158637, camilla.panico@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation of the 3D printing pipeline in the clinical setting for recurrent HGSOC (time frame: 3 years). 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 13 Mar 2025.