Skip to main content
OpenTrials
Completed

NCT Number: NCT05818020

Multidisciplinary Integrated Platform for a Technological Innvovative Approach to Oncotherapies

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Biologic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Padre Pio srl, Mondragone, CE, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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).

Treatment and study plan

Primary outcomes

  1. 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

  2. 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,

  3. 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).

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Official study title

Fighting Cancer Resistance: Multidisciplinary Integrated Platform for a Technological Innvovative Approach to Oncotherapies

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2023
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.