NCT06270602

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 2023Jul 2026

Study Start

First participant enrolled

July 14, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

December 22, 2025

Status Verified

July 1, 2025

Enrollment Period

2.8 years

First QC Date

January 29, 2024

Last Update Submit

December 16, 2025

Conditions

Oncology

Keywords

Oncological NetworkMultidisciplinary Oncology Groups

Outcome Measures

Primary Outcomes (13)

  • Incidence for each tumor of the patients included in the ROC platform

    Incidence for each tumor of the patients included in the ROC platform

    Every year up to 5 years

  • Evaluation of the time interval between GOM activities

    Time interval between reporting and taking charge by the GOM, the date diagnosis and the GOM meeting date, the first GOM meeting and the final therapeutic decision, the therapy decision and the therapeutic act, and the request for home assistance and the actual taking in charge by the ASL

    Every 6 months up to 3 years

  • Evaluation of the time interval between GOM activities

    Time interval between the request for home assistance and the actual taking in charge by the ASL

    Every 6 months up to 3 years

  • Evaluation of the time interval between GOM activities

    Time interval between the therapy decision and the therapeutic act

    Every 6 months up to 3 years

  • Evaluation of the time interval between GOM activities

    Time interval between the first GOM meeting and the final therapeutic decision

    Every 6 months up to 3 years

  • Evaluation of the time interval between GOM activities

    Time interval betweenthe date diagnosis and the GOM meeting date

    Every 6 months up to 3 years

  • Frequency of use of the services of the ROC platform

    Frequency of use of the services of the ROC platform

    Every 2 months up to 5 years

  • Descriptive analysis of each subgroup of patients (subdivision by tumor type)

    Descriptive analysis of each subgroup of patients (subdivision by tumor type)

    Every 6 months up to 5 years

  • Spatial analysis for each patient

    Spatial analysis for each patient

    Every year up to 5 years

  • Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA)

    Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA)

    Every 6 months up to 5 years

  • Percentage of patient included in clinical trial

    Percentage of patient included in clinical trial

    Every 2 months up to 5 years

  • Assessment of costs arising due to inefficiencies (repetition and inappropriateness of diagnostic tests; passive health mobility rate

    Assessment of costs arising due to inefficiencies (repetition and inappropriateness of diagnostic tests; passive health mobility rate

    Every 6 months up to 5 years

  • Prevalence for each tumor of the patients included in the ROC platform

    Prevalence for each tumor of the patients included in the ROC platform

    Every year up to 5 years

Secondary Outcomes (14)

  • Description of pharmacological strategies

    Every year up to 5 years

  • Description of diagnostic activities

    Every year up to 5 years

  • Description of surgical strategies

    Every year up to 5 years

  • Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA)

    Every 6 months up to 5 years

  • Description of each surgical approach

    Every year up to 5 years

  • +9 more secondary outcomes

Study Arms (2)

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

Other: Data collection (retrospective)

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).

Other: Data collection (prospective)

Interventions

Data collection (retrospective)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 A (Retrospective):
Data collection (prospective)OTHER

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

Cohort B (Prospective):

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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).

You may qualify if:

  • signed informed consent
  • registration in the ROC platform

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

A.O. Moscati

Avellino, Avellino, 83100, Italy

RECRUITING

Asl Avellino

Avellino, Avellino, 83100, Italy

RECRUITING

A.O. Rummo

Benevento, Benevento, 82100, Italy

RECRUITING

Asl Benevento

Benevento, Benevento, 82100, Italy

RECRUITING

Asl Caserta

Caserta, Caserta, 81035, Italy

RECRUITING

A.O. S.Anna S. Sebastiano

Caserta, Caserta, 81100, Italy

RECRUITING

Asl Napoli 2 Nord

Casavatore, Napoli, 80020, Italy

RECRUITING

Asl Napoli 3 Sud

Ercolano, Napoli, 80056, Italy

RECRUITING

A.O. Cardarelli

Naples, Napoli, 80131, Italy

RECRUITING

A.O. Dei Colli

Naples, Napoli, 80131, Italy

RECRUITING

Federico II

Naples, Napoli, 80131, Italy

RECRUITING

I.N.T. Pascale

Naples, Napoli, 80131, Italy

RECRUITING

A.O.U. Luigi Vanvitelli

Naples, Napoli, 80138, Italy

RECRUITING

Asl Napoli 1 Centro

Naples, Napoli, 80145, Italy

RECRUITING

Ospedale del Mare

Naples, Napoli, 80147, Italy

RECRUITING

Asl Salerno

Salerno, Salerno, 84124, Italy

RECRUITING

A.O.U. Ruggi

Salerno, Salerno, 84126, Italy

RECRUITING

Related Publications (2)

  • Porciello G, Crispo A, Di Carlo FPM, Rocco P, Luongo A, Russo N, Palumbo E, Vitale S, Coluccia S, Prete M, Di Lauro T, Abbadessa L, Di Martino A, Mozzillo AL, Racca E, Piccirillo A, Di Giacomo V, D'Amico M, Fontana M, Augustin LSA, D'Errico D, Coppola E, Stallone T, Maiolino P, Parascandolo I, Turra V, Pignata S; NUTRISCREEN Collaborative Research Group. Physical Activity, Nutritional Status, and Health-Related Quality of Life in Newly Diagnosed Cancer Patients: Evidence from the NUTRISCREEN Project. Nutrients. 2026 Mar 5;18(5):844. doi: 10.3390/nu18050844.

    PMID: 41830013DERIVED

  • 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.

    PMID: 40284239DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Data CollectionRetrospective StudiesLongitudinal Studies

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthCase-Control StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsCohort Studies

Study Officials

  • Sandro Pignata, M.D.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandro Pignata, M.D.

CONTACT

08117770755s.pignata@istitutotumori.na.it

Study Design

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

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 21, 2024

Study Start

July 14, 2023

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

December 22, 2025

Record last verified: 2025-07

Locations

IT(17)