Impact of Multidisciplinary and Radiologic Review on Outcome of Pancreatic Cancer Patients: an Observational Study
RevRadPAC
Impatto Della Revisione Radiologica Con Valutazione Multidisciplinare Nella Gestione Terapeutica Dei Pazienti Affetti da Adenocarcinoma Pancreatico (PAC)
1 other identifier
observational
316
1 country
1
Brief Summary
The investigators compared two different time periods respectively before and after the application of a dedicated diagnostic and therapeutic protocol for pancreatic ductal adenocarcinoma including multidisciplinary discussion and radiological review of cases, in order to evaluate the impact of the new protocol on surgical failures and overall survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2019
CompletedFirst Submitted
Initial submission to the registry
May 27, 2019
CompletedFirst Posted
Study publicly available on registry
June 4, 2019
CompletedJune 4, 2019
June 1, 2019
1 month
May 27, 2019
June 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of surgical failures on the total of eligible patients
proportion of patients with incomplete resection or who received surgery in which resection was not possible
immediately after surgery
Secondary Outcomes (2)
Overall survival
24 months
proportion of patients referred to different therapeutic options
up to 1 year
Study Arms (2)
PDAC patients diagnosed in 2008-2011
PDAC patients diagnosed in 2013-2016
Interventions
Since the introduction of the new protocol in 2012, a single central multidisciplinary team has been formalized, with weekly discussion of cases, including different specialists from all the provincial hospitals. CT scans of discussed cases are reviewed by one of two experienced radiologists based on pre-defined criteria.
Eligibility Criteria
The Reggio Emilia Pancreatic Cancer Register registered 1157 PDAC cases from 2008 to 2016. After exclusion of cases diagnosed in 2012, patients aged \>85 years and cancer staged as IV or with unknown stage, a total of 132 and 184 patients were included in analysis respectively for 2008-2011 and 2013-2016 periods.
You may qualify if:
- all consecutive inhabitants of the Reggio Emilia province with incident PDACs in 2008-2011 and 2013-2016 periods
You may not qualify if:
- pancreatic cancers with cytohistological diagnosis different from PDAC,
- diagnosis in 2012,
- metastatic disease at diagnosis (stage IV) or unknown stage at diagnosis,
- patients aged \>85 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda USL - IRCCS di Reggio Emilia
Reggio Emilia, 42123, Italy
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2019
First Posted
June 4, 2019
Study Start
June 15, 2018
Primary Completion
July 15, 2018
Study Completion
January 15, 2019
Last Updated
June 4, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share