The ONCOCAMP Study
ConditionOncology
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Cancer Institute, Naples
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
signed informed consent
registration in the ROC platform
Disqualifiers
None
Trial 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).
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Data collection (retrospective)
Other interventionCollection 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
Data collection (prospective)
Other interventionCollection of patient data entered in the ROC platform from the date in which the study is approved by the local ethical committee
Treatment groups
15,000 Participants
are divided into 2 treatment groupsGroup A: Cohort A (Retrospective):1 intervention
Group B: Cohort B (Prospective):1 intervention
Trial outcomes
Primary outcomes
1
Incidence for each tumor of the patients included in the ROC platform
Incidence for each tumor of the patients included in the ROC platform
Time frame
Every year up to 5 years2
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
Time frame
Every 6 months up to 3 years3
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
Time frame
Every 6 months up to 3 years4
Evaluation of the time interval between GOM activities
Time interval between the therapy decision and the therapeutic act
Time frame
Every 6 months up to 3 yearsSecondary outcomes
1
Description of pharmacological strategies
Evaluation of pharmacological strategies
Time frame
Every year up to 5 years2
Description of diagnostic activities
Evaluation of diagnostic activities
Time frame
Every year up to 5 years3
Description of surgical strategies
Evaluation of surgical strategies
Time frame
Every year up to 5 years4
Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA)
Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA)
Time frame
Every 6 months up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov