Pancreatic Ductal AdenocarcinomaRevRadPACNCT03973736
Impact of Multidisciplinary and Radiologic Review on Outcome of Pancreatic Cancer Patients: an Observational Study
An observational study of Pancreatic Ductal Adenocarcinoma, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- application of a diagnostic and therapeutic protocol (multidisciplinary discussion and radiological CT review)
- How many people
- 316 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2018to 15 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- all consecutive inhabitants of the Reggio Emilia province with incident PDACs in 2008-2011 and 2013-2016 periods
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impatto Della Revisione Radiologica Con Valutazione Multidisciplinare Nella Gestione Terapeutica Dei Pazienti Affetti da Adenocarcinoma Pancreatico (PAC)
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.
Read the detailed description
Since 2012 in Reggio Emilia a new diagnostic and therapeutic protocol has been implemented including multidisciplinary team discussion of non-metastatic PDACs and radiological review of CT scans by an experienced radiologist.
The aim of this study is to measure the impact of this new protocol on the occurrence of surgical failures, including incomplete resection or surgery in which resection resulted impossible at all. The investigators also describe the changes in overall survival and process indicators such as the proportion of patients referred to different therapeutic options (upfront surgery, neoadjuvant chemotherapy and no surgery) and the compliance with referral.
Through a population-based cohort study, the investigators evaluated the impact of the new protocol on therapeutic management and surgical outcome of patients with non-metastatic PDAC by comparing two four-years periods, respectively 2008-2011 and 2013-2016, before and after the introduction of the protocol. Since 2012 was the transitional year when the protocol was introduced, patients diagnosed with PDAC in 2012 were excluded.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- application of a diagnostic and therapeutic protocol (multidisciplinary discussion and radiological CT review)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of a diagnostic and therapeutic protocol (multidisciplinary discussion and radiological CT review)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| PDAC patients diagnosed in 2008-2011 | Not described | |
| PDAC patients diagnosed in 2013-2016 | Not described Receives: Other: application of a diagnostic and therapeutic protocol (multidisciplinary discussion and radiological CT review) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediately after surgery
Secondary outcomes (2)
Overall survival
overall survival (restricted to patients with at least 24 months follow-up)
Measured: 24 months
proportion of patients referred to different therapeutic options
proportion of patients referred to different therapeutic options (upfront surgery, neoadjuvant chemotherapy and no surgery)
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start15 Jun 2018
- Primary completion15 Jul 2018
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973736
- Sponsor's protocol ID
- 286/2018/OSS/AUSLRE
- Acronym
- RevRadPAC
- Status last verified
- Jun 2019
- First submitted
- 27 May 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impatto Della Revisione Radiologica Con Valutazione Multidisciplinare Nella Gestione Terapeutica Dei Pazienti Affetti da Adenocarcinoma Pancreatico (PAC)
- ClinicalTrials.gov ID
- NCT03973736
- Acronym / sponsor ID
- RevRadPAC / 286/2018/OSS/AUSLRE
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Since 2012 in Reggio Emilia a new diagnostic and therapeutic protocol has been implemented including multidisciplinary team discussion of non-metastatic PDACs and radiological review of CT scans by an experienced radiologist.
The aim of this study is to measure the impact of this new protocol on the occurrence of surgical failures, including incomplete resection or surgery in which resection resulted impossible at all. The investigators also describe the changes in overall survival and process indicators such as the proportion of patients referred to different therapeutic options (upfront surgery, neoadjuvant chemotherapy and no surgery) and the compliance with referral.
Through a population-based cohort study, the investigators evaluated the impact of the new protocol on therapeutic management and surgical outcome of patients with non-metastatic PDAC by comparing two four-years periods, respectively 2008-2011 and 2013-2016, before and after the introduction of the protocol. Since 2012 was the transitional year when the protocol was introduced, patients diagnosed with PDAC in 2012 were excluded.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDAC patients diagnosed in 2008-2011 | – | – |
| PDAC patients diagnosed in 2013-2016 | – | Other: application of a diagnostic and therapeutic protocol (multidisciplinary discussion and radiological CT review) |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- all consecutive inhabitants of the Reggio Emilia province with incident PDACs in 2008-2011 and 2013-2016 periods
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| application of a diagnostic and therapeutic protocol (multidisciplinary discussion and radiological CT review)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. | Other | PDAC patients diagnosed in 2013-2016 |
Primary outcome
Proportion of surgical failures on the total of eligible patients
Time frame: immediately after surgery
proportion of patients with incomplete resection or who received surgery in which resection was not possible
2 secondary outcomes
Overall survival
Time frame: 24 months
proportion of patients referred to different therapeutic options
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of surgical failures on the total of eligible patients (time frame: immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.