Multidisciplinary Integrated Platform for a Technological Innvovative Approach to Oncotherapies

NCT ID: NCT05818020

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 269 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-02
• Study Completion Date: 2022-06-30

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.

Conditions

Biologic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Naples

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicola Normanno

Role: PRINCIPAL_INVESTIGATOR

IRCCS I.N.T. "G. Pascale"

Locations

Clinica Padre Pio srl

Mondragone, CE, Italy

Pineta Grande Hospital

Castel Volturno, Napoli, Italy

Istituto Nazionale Tumori | "Fondazione Pascale"

Napoli, , Italy

Countries

Italy

Other Identifiers

40/19oss

Identifier Type: OTHER

Identifier Source: secondary_id

Campania Oncoterapie

Identifier Type: -

Identifier Source: org_study_id