The ONCOCAMP Study

Официальное название

A Retrospective-prospective, Observational, Multicentric Study to Record Data From the ROC Platform and Monitor the ROC Performance

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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
• Другое 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

Первичные конечные точки

• Incidence for each tumor of the patients included in the ROC platform [Срок оценки: Every year up to 5 years]
• Evaluation of the time interval between GOM activities [Срок оценки: Every 6 months up to 3 years]
• Evaluation of the time interval between GOM activities [Срок оценки: Every 6 months up to 3 years]
• Evaluation of the time interval between GOM activities [Срок оценки: Every 6 months up to 3 years]
• Evaluation of the time interval between GOM activities [Срок оценки: Every 6 months up to 3 years]
• Evaluation of the time interval between GOM activities [Срок оценки: Every 6 months up to 3 years]
• Frequency of use of the services of the ROC platform [Срок оценки: Every 2 months up to 5 years]
• Descriptive analysis of each subgroup of patients (subdivision by tumor type) [Срок оценки: Every 6 months up to 5 years]
• Spatial analysis for each patient [Срок оценки: Every year up to 5 years]
• Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA) [Срок оценки: Every 6 months up to 5 years]

Вторичные конечные точки (12)

• Description of pharmacological strategies [Срок оценки: Every year up to 5 years]
• Description of diagnostic activities [Срок оценки: Every year up to 5 years]
• Description of surgical strategies [Срок оценки: Every year up to 5 years]
• Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA) [Срок оценки: Every 6 months up to 5 years]
• Description of each surgical approach [Срок оценки: Every year up to 5 years]
• Description of the different surgical techniques among the centers [Срок оценки: Every year up to 5 years]
• Patients' quality of life [Срок оценки: Every year up to 5 years]
• Patients' reported outcome [Срок оценки: Every year up to 5 years]
• Patients' satisfaction and evaluation of the diagnostic / therapeutic path [Срок оценки: Every year up to 5 years]
• Correlation analysis among risk factors and diagnostic / therapeutic delay or poor prognosis [Срок оценки: Every year up to 5 years]
• Dependence analysis between the conditions of social deprivation of ROC patients and the time to the first GOM visit [Срок оценки: Every year up to 5 years]
• Dependence analysis among costs, socio-demographic characteristics and some variables related to the diagnostic / therapeutic path [Срок оценки: Every year up to 5 years]

Критерии участия

Критерии включения

• signed informed consent
• registration in the ROC platform

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 17 центров

• A.O. Moscati — Avellino
• Asl Avellino — Avellino
• A.O. Rummo — Benevento
• Asl Benevento — Benevento
• Asl Caserta — Caserta
• A.O. S.Anna S. Sebastiano — Caserta
• Asl Napoli 2 Nord — Casavatore
• Asl Napoli 3 Sud — Ercolano
• … и ещё 9 центров

Публикации

• 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 PMID 41830013
• 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 i PMID 40284239

Идентификаторы

NCT: NCT06270602 · ONCOCAMP · 6/23 oss

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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