Trial Title:
The ONCOCAMP Study
NCT ID:
NCT06270602
Condition:
Oncology
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Oncological Network
Multidisciplinary Oncology Groups
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
Data collection (retrospective)
Description:
Collection of patient data entered in the ROC platform from the beginning activation of
the platform (November 2018) until the date on which the study is approved by the local
ethics committee
Arm group label:
Cohort A (Retrospective):
Intervention type:
Other
Intervention name:
Data collection (prospective)
Description:
Collection of patient data entered in the ROC platform from the date in which the study
is approved by the local ethical committee
Arm group label:
Cohort B (Prospective):
Summary:
The present study is a retrospective-prospective observational and multicentric study
aiming to collect data relating to all patients included in the ROC platform. All ROC
centers will be involved in the present study.
Detailed description:
The ROC platform therefore represents a multicenter database and a growing source of data
and information regarding cancer patients in the Campania region. The need for
multicenter databases is supported by the results obtained with both retrospective and
prospective studies. Many retrospective studies have led to changes in some of the
available guidelines. Important advantages of this study include representativeness of
the analyzed cohort to all patients with a specific cancer and a large sample size that
provides sufficient statistical power to detect differences across different patient
groups. The data extracted from the ROC have the potential to produce knowledge, to guide
decision-making, and to manage more effectively the challenges of fighting cancer in our
region. The Campania region counts more than 6 million people, and it is characterized by
a worst oncological outcome compared to the average data of other Italian region: the ROC
platform has the potential to analyze the effect of a public intervention in the field of
oncology care. Therefore, the primary aim of this study is to create a
retrospective-prospective registry of all cancer patients entering the ROC platform and
in a GOM path describing the primary and secondary endpoints.
Criteria for eligibility:
Study pop:
1. All consecutive patients entered in the ROC platform from the start of platform
activation (November 2018) until the date in which the study is approved by the
local ethical committee (The retrospective cohort will be made by more than 40000
patients already included in the platform and entered a GOM path.
2. All consecutive patients who enter in the ROC platform as for clinical practice from
the date in which the study is approved by the local ethical committee (Investigator
is allowed to enroll patients).
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- signed informed consent
- registration in the ROC platform
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Asl Napoli 2 Nord
Address:
City:
Casavatore
Zip:
80020
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Filomena Sibilio, M.D.
Facility:
Name:
Asl Napoli 3 Sud
Address:
City:
Ercolano
Zip:
80056
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Mario Fusco, M.D.
Facility:
Name:
A.O. Moscati
Address:
City:
Avellino
Zip:
83100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Cesare Gridelli, M.D.
Facility:
Name:
Asl Avellino
Address:
City:
Avellino
Zip:
83100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giuseppe Genua, M.D.
Facility:
Name:
A.O. Rummo
Address:
City:
Benevento
Zip:
82100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Antonio Grimaldi, M.D.
Facility:
Name:
Asl Benevento
Address:
City:
Benevento
Zip:
82100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Elena Fossi, M.D.
Facility:
Name:
Asl Caserta
Address:
City:
Caserta
Zip:
81035
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Antonella Guida, M.D.
Facility:
Name:
A.O. S.Anna S. Sebastiano
Address:
City:
Caserta
Zip:
81100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Michele Orditura, M.D.
Facility:
Name:
A.O. Cardarelli
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Ferdinando Riccardi, M.D.
Facility:
Name:
A.O. Dei Colli
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Vincenzo Montesarchio, M.D.
Facility:
Name:
Federico II
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Sabino De Placido, M.D.
Facility:
Name:
I.N.T. Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Sandro Pignata, M.D.
Facility:
Name:
A.O.U. Luigi Vanvitelli
Address:
City:
Napoli
Zip:
80138
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Fortunato Ciardiello, M.D.
Facility:
Name:
Asl Napoli 1 Centro
Address:
City:
Napoli
Zip:
80145
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Tiziana Spinosa, M.D.
Facility:
Name:
Ospedale del Mare
Address:
City:
Napoli
Zip:
80147
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Bruno Daniele, M.D.
Facility:
Name:
Asl Salerno
Address:
City:
Salerno
Zip:
84124
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giuseppe Di Lorenzo, M.D.
Facility:
Name:
A.O.U. Ruggi
Address:
City:
Salerno
Zip:
84126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Stefano Pepe, M.D.
Start date:
July 14, 2023
Completion date:
July 2026
Lead sponsor:
Agency:
National Cancer Institute, Naples
Agency class:
Other
Source:
National Cancer Institute, Naples
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06270602
