Multidisciplinary Integrated Platform for a Technological Innvovative Approach to Oncotherapies

NCT05818020 | Completed

• 2 other identifiers: Campania Oncoterapie40/19oss
• Study Type: observational
• Target: 269
• Locations: 1 country
• Sites: 3

Brief Summary

This is multicentric, observational, and retro- prospective study.

Conditions

Biologic

Keywords

Realization of a regional "Technology platform"

Outcome Measures

Primary Outcomes (5)

• 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

  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,

  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).

  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.

  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.

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosis of any of the following diseases:
• breast cancer;
• melanoma;
• hepatocarcinoma;
• gynecological cancer;
• colorectal cancer;
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (3)

Clinica Padre Pio srl

Mondragone, CE, 81034, Italy

Location

Pineta Grande Hospital

Castel Volturno, Napoli, 80130, Italy

Location

Istituto Nazionale Tumori | "Fondazione Pascale"

Napoli, 810131, Italy

Location

Study Officials

• Nicola Normanno

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 18, 2023
• Study Start: March 2, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

IT (3)