BiologicNCT05818020
Multidisciplinary Integrated Platform for a Technological Innvovative Approach to Oncotherapies
An observational study of Biologic, run by National Cancer Institute, Naples at 3 sites in Italy.
Trial summary
This is multicentric, observational, and retro- prospective study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biologic
- How many people
- 269 participants
- Where
- 3 sitesItaly
- Study dates
- 2 Mar 2020to 30 Jun 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects participating in the study were diagnosed with a tumor pathology between the following: Breast cancers, melanomas (cutaneous and non-cutaneous), liver tumors, bile duct tumors, colorectal tumors, lung tumors, sarcomas, pancreatic tumors, tumors of the endocrine glands (thyroid), digestive system tumors (classifying rare ones), urological and male genital tumors (classifying rare ones), female genital tumors (classifying rare ones); rare skin tumors.
Who may be able to join
- Diagnosis of any of the following diseases:
- breast cancer;
- melanoma;
- hepatocarcinoma;
- gynecological cancer;
- colorectal cancer;
Show all 18Show fewer
- lung cancer.
- sarcoma;
- pancreatic tumor;
- tumor of endocrine glands (thyroid);
- digestive system tumor (classifying rare ones);
- urological and/or male genital tumor (classifying rare ones);
- female genital tumor (classifying rare ones);
- rare skin tumor;
- Signature of the informed consent for the study.
- Age 18 years
- Biological material leftover from biopsy or surgery, and the residual to the activities of clinical assistance analysis.
- No ongoing treatment for oncological diseases at the time of collection.
Who cannot join
- Patients meeting any of the following criteria are not eligible for the present study:
- Patients aged < 18 years;
- Patients who have not signed the informed consent;
- Positive history of previous neoplasms (only for "naive" patients);
- Positive history of synchronous/metachronous oncological pathologies different from those specified for recruitment (only for "naive" patients);
- Ongoing immunosuppressive therapy (only for "naive" patients).
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Pineta Grande Hospital
Castel Volturno, Napoli, 80130
Clinica Padre Pio srl
Mondragone, CE, 81034
Istituto Nazionale Tumori | "Fondazione Pascale"
Naples, 810131
About this study
Official title: Fighting Cancer Resistance: Multidisciplinary Integrated Platform for a Technological Innvovative Approach to Oncotherapies
This is multicentric, observational, and retro- prospective study.
Read the detailed description
The project aims to develop a regional platform for innovative disease treatment oncology. In particular, an integrated platform will be created with several complementary skills among them, which have as their common objective to increase knowledge and the possibilities of surgery for certain types of cancer.
The actions implemented in this project will be as follows:
- Improvement of primary and secondary prevention strategies with precocious diagnostic devices;
- Optimization of therapeutic treatments by custom drawing of the scheme therapeutic;
- Improved therapeutic efficacy for high social impact resistant neoplasms development of innovative treatments such as personalized therapeutic vaccines and small molecules;
- Improving patient compliance and quality of life accompanied by less need of hospitalization of the patient himself with consequent decongestion of hospital admissions;
- Reduction of health costs as a result of early diagnosis and new therapies more effective and less invasive;
- Increasing regional health and technological attractiveness in a high bio-medical sector social and health impact.
- Conditions
- Biologic
- Keywords
- Realization of a regional "Technology platform"
What is being measured
The primary outcome is the main question the study is designed to answer.
Sampling of biological material from cancer patients.
Sampling size and type of biomaterials, residues in diagnosis and/or clinical activities care, collected by cancer patients and properly stored will include:
- cells and/or tissue fragments during surgical excision (with "open" approach/ laparoscopic/ robotic) of the tumor or parts of the same tissue
Measured: 3 years
Sampling of biological material from cancer patients.
Sampling size and type of biomaterials, residues in diagnosis and/or clinical activities care, collected by cancer patients and properly stored will include:- blood, cell samples, urine/other biological liquids (saliva, excreted, ascites, pleural fluids, etc.) and faeces,
Measured: 3 years
Sampling of biological material from cancer patients.
Sampling size and type of biomaterials, residues in diagnosis and/or clinical activities care, collected by cancer patients and properly stored will include:- samples fixed in formalin and included in paraffin (Formalin-fixed paraffin-embedded, FFPE).
Measured: 3 years
Identification of biomarkers to be used for the development of early diagnostic systems
The alteration of the levels of biomarkers, measured by the use of analytical techniques based on mass spectrometry, and the correlation of such levels measured against control samples will allow the development and training of advanced statistics models to identify and define the type and the status of the oncological pathology.
Measured: 3 years
Monitoring the progress of drug therapies
The identification of biomarkers used to monitor the drug therapie defined as "pharmacometabolomics" will allow to calibrate finely and optimize the selection of therapeutic protocols allowing to reduce the costs of prescription and assistance, while improving the patient's health.
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 posted18 Apr 2023
- Study start2 Mar 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiologicStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicola Normanno, Principal investigator, IRCCS I.N.T. "G. Pascale"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818020
- Sponsor's protocol ID
- Campania Oncoterapie
- Other IDs
- 40/19oss
- Status last verified
- Jun 2024
- First submitted
- 22 Mar 2023
- Last updated
- 26 Jun 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 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fighting Cancer Resistance: Multidisciplinary Integrated Platform for a Technological Innvovative Approach to Oncotherapies
- ClinicalTrials.gov ID
- NCT05818020
- Acronym / sponsor ID
- Campania Oncoterapie
- Conditions
- Biologic
- Keywords
- Realization of a regional "Technology platform"
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 18 Apr 2023 (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 is multicentric, observational, and retro- prospective study.
Detailed description
The project aims to develop a regional platform for innovative disease treatment oncology. In particular, an integrated platform will be created with several complementary skills among them, which have as their common objective to increase knowledge and the possibilities of surgery for certain types of cancer.
The actions implemented in this project will be as follows:
- Improvement of primary and secondary prevention strategies with precocious diagnostic devices;
- Optimization of therapeutic treatments by custom drawing of the scheme therapeutic;
- Improved therapeutic efficacy for high social impact resistant neoplasms development of innovative treatments such as personalized therapeutic vaccines and small molecules;
- Improving patient compliance and quality of life accompanied by less need of hospitalization of the patient himself with consequent decongestion of hospital admissions;
- Reduction of health costs as a result of early diagnosis and new therapies more effective and less invasive;
- Increasing regional health and technological attractiveness in a high bio-medical sector social and health impact.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects participating in the study were diagnosed with a tumor pathology between the following: Breast cancers, melanomas (cutaneous and non-cutaneous), liver tumors, bile duct tumors, colorectal tumors, lung tumors, sarcomas, pancreatic tumors, tumors of the endocrine glands (thyroid), digestive system tumors (classifying rare ones), urological and male genital tumors (classifying rare ones), female genital tumors (classifying rare ones); rare skin tumors.
Key inclusion criteria (18 listed)
- Diagnosis of any of the following diseases:
- Signature of the informed consent for the study.
- Age 18 years
- Biological material leftover from biopsy or surgery, and the residual to the activities of clinical assistance analysis.
- No ongoing treatment for oncological diseases at the time of collection.
Key exclusion criteria (6 listed)
- Patients aged < 18 years;
- Patients who have not signed the informed consent;
- Positive history of previous neoplasms (only for "naive" patients);
- Positive history of synchronous/metachronous oncological pathologies different from those specified for recruitment (only for "naive" patients);
- Ongoing immunosuppressive therapy (only for "naive" 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
Sampling of biological material from cancer patients.
Time frame: 3 years
Sampling size and type of biomaterials, residues in diagnosis and/or clinical activities care, collected by cancer patients and properly stored will include: - cells and/or tissue fragments during surgical excision (with "open" approach/ laparoscopic/ robotic) of the tumor or parts of the same tissue
Sampling of biological material from cancer patients.
Time frame: 3 years
Sampling size and type of biomaterials, residues in diagnosis and/or clinical activities care, collected by cancer patients and properly stored will include:- blood, cell samples, urine/other biological liquids (saliva, excreted, ascites, pleural fluids, etc.) and faeces,
Sampling of biological material from cancer patients.
Time frame: 3 years
Sampling size and type of biomaterials, residues in diagnosis and/or clinical activities care, collected by cancer patients and properly stored will include:- samples fixed in formalin and included in paraffin (Formalin-fixed paraffin-embedded, FFPE).
Identification of biomarkers to be used for the development of early diagnostic systems
Time frame: 3 years
The alteration of the levels of biomarkers, measured by the use of analytical techniques based on mass spectrometry, and the correlation of such levels measured against control samples will allow the development and training of advanced statistics models to identify and define the type and the status of the oncological pathology.
Monitoring the progress of drug therapies
Time frame: 3 years
The identification of biomarkers used to monitor the drug therapie defined as "pharmacometabolomics" will allow to calibrate finely and optimize the selection of therapeutic protocols allowing to reduce the costs of prescription and assistance, while improving the patient's health.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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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.
Nicola Normanno principal investigator
IRCCS I.N.T. "G. Pascale"
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biologic, run by National Cancer Institute, Naples at 3 sites 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 18 inclusion and 6 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: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sampling of biological material from cancer patients. (time frame: 3 years). The study lists 5 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 26 Jun 2024; AzTrials last refreshed its copy on 31 Oct 2026.