Clinical trial NCT05818020: Multidisciplinary Integrated Platform for a Technological Innvovative Approach to Oncotherapies
Official title: Fighting Cancer Resistance: Multidisciplinary Integrated Platform for a Technological Innvovative Approach to Oncotherapies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biologic
Keywords: Realization of a regional "Technology platform"
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of any of the following diseases:

  1. breast cancer;
  2. melanoma;
  3. hepatocarcinoma;
  4. gynecological cancer;
  5. colorectal cancer;
  6. lung cancer.
  7. sarcoma;
  8. pancreatic tumor;
  9. tumor of endocrine glands (thyroid);
  10. digestive system tumor (classifying rare ones);
  11. urological and/or male genital tumor (classifying rare ones);
  12. female genital tumor (classifying rare ones);
  13. 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.

Exclusion Criteria:

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).

Primary outcomes:
measure: Sampling of biological material from cancer patients.
timeFrame: 3 years
measure: Sampling of biological material from cancer patients.
timeFrame: 3 years
measure: Sampling of biological material from cancer patients.
timeFrame: 3 years
measure: Identification of biomarkers to be used for the development of early diagnostic systems
timeFrame: 3 years
measure: Monitoring the progress of drug therapies
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mondragone
country: Italy
facility: Clinica Padre Pio srl
state: CE
city: Castel Volturno
country: Italy
facility: Pineta Grande Hospital
state: Napoli
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori | "Fondazione Pascale"
Study officials:
affiliation: IRCCS I.N.T. "G. Pascale"
name: Nicola Normanno
role: PRINCIPAL_INVESTIGATOR
References: