The ONCOCAMP Study

NCT ID: NCT06270602

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-14

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oncology

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Oncological Network Multidisciplinary Oncology Groups

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort A (Retrospective):

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 (Investigator is allowed to enroll patients) will be enrolled. The retrospective cohort will be made by more than 40000 patients already included in the platform and entered a GOM path

Data collection (retrospective)

Intervention Type OTHER

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

Cohort B (Prospective):

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).

Data collection (prospective)

Intervention Type OTHER

Collection of patient data entered in the ROC platform from the date in which the study is approved by the local ethical committee

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Data collection (retrospective)

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

Intervention Type OTHER

Data collection (prospective)

Collection of patient data entered in the ROC platform from the date in which the study is approved by the local ethical committee

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* signed informed consent
* registration in the ROC platform
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute, Naples

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sandro Pignata, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

A.O. Moscati

Avellino, Avellino, Italy

Site Status RECRUITING

Asl Avellino

Avellino, Avellino, Italy

Site Status RECRUITING

A.O. Rummo

Benevento, Benevento, Italy

Site Status RECRUITING

Asl Benevento

Benevento, Benevento, Italy

Site Status RECRUITING

Asl Caserta

Caserta, Caserta, Italy

Site Status RECRUITING

A.O. S.Anna S. Sebastiano

Caserta, Caserta, Italy

Site Status RECRUITING

Asl Napoli 2 Nord

Casavatore, Napoli, Italy

Site Status RECRUITING

Asl Napoli 3 Sud

Ercolano, Napoli, Italy

Site Status RECRUITING

A.O. Cardarelli

Napoli, Napoli, Italy

Site Status RECRUITING

A.O. Dei Colli

Napoli, Napoli, Italy

Site Status RECRUITING

Federico II

Napoli, Napoli, Italy

Site Status RECRUITING

I.N.T. Pascale

Napoli, Napoli, Italy

Site Status RECRUITING

A.O.U. Luigi Vanvitelli

Napoli, Napoli, Italy

Site Status RECRUITING

Asl Napoli 1 Centro

Napoli, Napoli, Italy

Site Status RECRUITING

Ospedale del Mare

Napoli, Napoli, Italy

Site Status RECRUITING

Asl Salerno

Salerno, Salerno, Italy

Site Status RECRUITING

A.O.U. Ruggi

Salerno, Salerno, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sandro Pignata, M.D.

Role: CONTACT

Phone: 08117770755

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Cesare Gridelli, M.D.

Role: primary

Giuseppe Genua, M.D.

Role: primary

Antonio Grimaldi, M.D.

Role: primary

Elena Fossi, M.D.

Role: primary

Antonella Guida, M.D.

Role: primary

Michele Orditura, M.D.

Role: primary

Filomena Sibilio, M.D.

Role: primary

Mario Fusco, M.D.

Role: primary

Ferdinando Riccardi, M.D.

Role: primary

Vincenzo Montesarchio, M.D.

Role: primary

Sabino De Placido, M.D.

Role: primary

Sandro Pignata, M.D.

Role: primary

Fortunato Ciardiello, M.D.

Role: primary

Tiziana Spinosa, M.D.

Role: primary

Bruno Daniele, M.D.

Role: primary

Giuseppe Di Lorenzo, M.D.

Role: primary

Stefano Pepe, M.D.

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Porciello G, Di Lauro T, Luongo A, Coluccia S, Prete M, Abbadessa L, Coppola E, Di Martino A, Mozzillo AL, Racca E, Piccirillo A, Di Giacomo V, Fontana M, D'Amico M, Palumbo E, Vitale S, D'Errico D, Turra V, Parascandolo I, Stallone T, Augustin LSA, Crispo A, Celentano E, Pignata S. Optimizing Nutritional Care with Machine Learning: Identifying Sarcopenia Risk Through Body Composition Parameters in Cancer Patients-Insights from the NUTritional and Sarcopenia RIsk SCREENing Project (NUTRISCREEN). Nutrients. 2025 Apr 18;17(8):1376. doi: 10.3390/nu17081376.

Reference Type DERIVED
PMID: 40284239 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

6/23 oss

Identifier Type: OTHER

Identifier Source: secondary_id

ONCOCAMP

Identifier Type: -

Identifier Source: org_study_id