Solid TumorACC PlatformNCT06339541
The ACC Preclinical Research Platform for Precision Oncology
An observational study of Solid Tumor and Hematologic Neoplasms, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
Trial summary
The ACC Preclinical Research Platform for Precision Oncology is a retrospective and prospective observational study focused on the implementation and validation of the application of PDCM (Patient Derived Cancer Models) generated from tissues or cells of patients with neoplastic disease, as a tool to improve molecular… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Solid Tumor, Hematologic Neoplasms
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jun 2023to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients, including paediatric patients, with solid and haematological malignancies for whom tissue or tumour cell material is available.
Who may be able to join
- Patients, including paediatric patients, with solid and haematological malignancies for whom tissue or tumour cell material is available.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
Candiolo, Turin, 10060
Marco Asioli, BSc, +390119933463, marco.asioli@ircc.it
Enzo Medico, MD
About this study
Official title: La Piattaforma ACC di Ricerca Preclinica Per l'Oncologia di Precisione
The ACC Preclinical Research Platform for Precision Oncology is a retrospective and prospective observational study focused on the implementation and validation of the application of PDCM (Patient Derived Cancer Models) generated from tissues or cells of patients with neoplastic disease, as a tool to improve molecular and biological knowledge of tumours and to test the efficacy and sensitivity of pharmacological treatments.
Read the detailed description
This is a retrospective and prospective observational study, focused on the implementation and validation of the application of PDCM, generated from tissue or cells of patients, including paediatric patients, with solid and haematological malignancies, as a tool to improve molecular and biological knowledge of tumours and to test the efficacy and sensitivity of pharmacological treatments.
An up-to-date database of all PDCMs available at the participating italian hospitals will be generated and enriched with new models generated during the course of the project. The sharing of models and procedures between the different hospitals will facilitate their molecular and phenotypic characterisation, also in parallel with the tumours of origin, as well as their validation as tools for testing the efficacy of drugs for precision medicine. By establishing common workflows and standards and performing cross-validation experiments it is planned to build a network of reference centres as a resource for drug screening on 2D and 3D models.
- Conditions
- Solid Tumor, Hematologic Neoplasms
- Medical subject headings
- Hematologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
number of PDCM (patient derived cancer models)
PDCM will be generated from tissues and cells
Measured: 12 months
number of Whole Exome Sequencing (WES) e RNA-seq performed
WES and RNA seq will be performed on tissues and blood
Measured: 12 months
Secondary outcomes (1)
number of PDCM shared within the network
PDCM will be generated from tissues and cells and shared within the network
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start5 Jun 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Collaborators
- Alleanza Contro il Cancro
- Responsible party
- Principal investigator, Enzo Medico, Fondazione del Piemonte per l'Oncologia
- Investigators
- Enzo Medico, MD, Principal investigator, Fondazione del Piemonte per l'Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339541
- Sponsor's protocol ID
- 029-FPO23
- Acronym
- ACC Platform
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- La Piattaforma ACC di Ricerca Preclinica Per l'Oncologia di Precisione
- ClinicalTrials.gov ID
- NCT06339541
- Acronym / sponsor ID
- ACC Platform / 029-FPO23
- Conditions
- Solid Tumor, Hematologic Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Collaborators
- Alleanza Contro il Cancro
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 1 Apr 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 ACC Preclinical Research Platform for Precision Oncology is a retrospective and prospective observational study focused on the implementation and validation of the application of PDCM (Patient Derived Cancer Models) generated from tissues or cells of patients with neoplastic disease, as a tool to improve molecular and biological knowledge of tumours and to test the efficacy and sensitivity of pharmacological treatments.
Detailed description
This is a retrospective and prospective observational study, focused on the implementation and validation of the application of PDCM, generated from tissue or cells of patients, including paediatric patients, with solid and haematological malignancies, as a tool to improve molecular and biological knowledge of tumours and to test the efficacy and sensitivity of pharmacological treatments.
An up-to-date database of all PDCMs available at the participating italian hospitals will be generated and enriched with new models generated during the course of the project. The sharing of models and procedures between the different hospitals will facilitate their molecular and phenotypic characterisation, also in parallel with the tumours of origin, as well as their validation as tools for testing the efficacy of drugs for precision medicine. By establishing common workflows and standards and performing cross-validation experiments it is planned to build a network of reference centres as a resource for drug screening on 2D and 3D models.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients, including paediatric patients, with solid and haematological malignancies for whom tissue or tumour cell material is available.
Key inclusion criteria (1 listed)
- Patients, including paediatric patients, with solid and haematological malignancies for whom tissue or tumour cell material is available.
Key exclusion criteria (1 listed)
- none
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
number of PDCM (patient derived cancer models)
Time frame: 12 months
PDCM will be generated from tissues and cells
number of Whole Exome Sequencing (WES) e RNA-seq performed
Time frame: 12 months
WES and RNA seq will be performed on tissues and blood
1 secondary outcome
number of PDCM shared within the network
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
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A Study of JNJ-1761981 in Participants With Solid Tumors
Neoplasms
Not yet recruitingPhase 1
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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. This study is not recruiting at the moment.
Enzo Medico, MD principal investigator
Fondazione del Piemonte per l'Oncologia
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 Solid Tumor and Hematologic Neoplasms, run by Fondazione del Piemonte per l'Oncologia 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 1 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: status not confirmed, as of the sponsor's last update on 1 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enzo Medico, MD (+390119933234, enzo.medico@ircc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of PDCM (patient derived cancer models) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 1 Apr 2024.