Pancreatic Ductal AdenocarcinomaNCT04605237
Pancreatic Cancer Recurrence in the Netherlands
An observational study of Pancreatic Ductal Adenocarcinoma and Pancreatic Cancer, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The aim of this nationwide, observational cohort study is to evaluate current surveillance strategies after primary resection of pancreatic ductal adenocarcinoma (PDAC) in the Netherlands, with regard to the detection, treatment and survival of PDAC recurrence. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer, Pancreas Cancer
- How many people
- 1,750 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2014to 1 Jul 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients registered within the prospective, mandatory Dutch Pancreatic Cancer Audit who underwent resection of histologically proven PDAC.
Who may be able to join
- Patients undergoing a pancreatic resection (PPPD, Whipple, distal pancreatectomy or total pancreatectomy) for histologically proven PDAC in one of the 16 Dutch centers for pancreatic surgery
Who cannot join
- Patients with 30-day postoperative mortality
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht, 3584 CX
Iris van Goor, MD, +31631917882, I.W.J.vanGoor-5@umcutrecht.nl
Lois Daamen, MD, +31651223276, L.A.Daamen-3@umcutrecht.nl
About this study
Official title: Detection, Treatment and Survival of Pancreatic Cancer Recurrence in the Netherlands
The aim of this nationwide, observational cohort study is to evaluate current surveillance strategies after primary resection of pancreatic ductal adenocarcinoma (PDAC) in the Netherlands, with regard to the detection, treatment and survival of PDAC recurrence.
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PDAC recurrence
Incidence of PDAC recurrence within the Netherlands; PDAC recurrence is either pathologically proven, or suspected through cross-sectional imaging, preferably confirmed by consensus during a multidisciplinary meeting.
Measured: Within a follow-up period up to 5 years
Patterns of PDAC recurrence
- Asymptomatic vs. symptomatic: Symptomatic recurrence is defined as the presence of symptoms suggestive for PDAC recurrence at recurrence diagnosis. If PDAC recurrence is detected in absence of suspected symptoms, disease recurrence was defined as asymptomatic.
- First site of recurrence: isolated local recurrence, liver-only, lung-only, multiple-site, other isolated distant
- Early vs. late recurrence: disease-free survival ≥12 months vs. <12 months
Measured: Within a follow-up period up to 5 years
Treatment of PDAC recurrence
Either systemic and/or local treatment or best-supportive-care
Measured: Within a follow-up period up to 5 years
Survival
Overall survival (from the time of resection), disease-free survival (from the time of resection), post-recurrence survival (from the time of recurrence diagnosis)
Measured: Within a follow-up period up to 5 years
Secondary outcomes (4)
Presence of symptoms at time of (suspected) recurrence
Which symptoms are associated with PDAC recurrence?
Measured: Within a follow-up period up to 5 years
Performance score at time of recurrence detection
What is the ECOG performance score of patients at time of recurrence diagnosis?
Measured: Within a follow-up period up to 5 years
Use of imaging procedures during follow-up
How much imaging procedures are performed during postoperative follow-up for the detection of PDAC recurrence? Are these procedures routinely performed?
Measured: Within a follow-up period up to 5 years
Number of histologically confirmed recurrences
How often is PDAC recurrence histologically confirmed?
Measured: Within a follow-up period up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Jan 2014
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
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.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Erasmus Medical Center, Catharina Ziekenhuis Eindhoven, Radboud University Medical Center, University Medical Center Groningen, Jeroen Bosch Ziekenhuis, Leiden University Medical Center, Maastricht University Medical Center, Maasstad Hospital, Amphia Hospital, Onze Lieve Vrouwe Gasthuis, Reinier de Graaf Groep, Isala, St. Antonius Hospital
- Responsible party
- Principal investigator, Prof. dr. I.Q. Molenaar, MD, PhD, UMC Utrecht
- Investigators
- I. Quintus Molenaar, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605237
- Sponsor's protocol ID
- 18-036/C
- Status last verified
- Feb 2023
- First submitted
- 15 Oct 2020
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection, Treatment and Survival of Pancreatic Cancer Recurrence in the Netherlands
- ClinicalTrials.gov ID
- NCT04605237
- Acronym / sponsor ID
- 18-036/C
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,750 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Erasmus Medical Center, Catharina Ziekenhuis Eindhoven, Radboud University Medical Center, University Medical Center Groningen, Jeroen Bosch Ziekenhuis, Leiden University Medical Center, Maastricht University Medical Center, Maasstad Hospital, Amphia Hospital, Onze Lieve Vrouwe Gasthuis, Reinier de Graaf Groep, Isala, St. Antonius Hospital
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 27 Oct 2020 (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 aim of this nationwide, observational cohort study is to evaluate current surveillance strategies after primary resection of pancreatic ductal adenocarcinoma (PDAC) in the Netherlands, with regard to the detection, treatment and survival of PDAC recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients registered within the prospective, mandatory Dutch Pancreatic Cancer Audit who underwent resection of histologically proven PDAC.
Key inclusion criteria (1 listed)
- Patients undergoing a pancreatic resection (PPPD, Whipple, distal pancreatectomy or total pancreatectomy) for histologically proven PDAC in one of the 16 Dutch centers for pancreatic surgery
Key exclusion criteria (1 listed)
- Patients with 30-day postoperative mortality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of PDAC recurrence
Time frame: Within a follow-up period up to 5 years
Incidence of PDAC recurrence within the Netherlands; PDAC recurrence is either pathologically proven, or suspected through cross-sectional imaging, preferably confirmed by consensus during a multidisciplinary meeting.
Patterns of PDAC recurrence
Time frame: Within a follow-up period up to 5 years
* Asymptomatic vs. symptomatic: Symptomatic recurrence is defined as the presence of symptoms suggestive for PDAC recurrence at recurrence diagnosis. If PDAC recurrence is detected in absence of suspected symptoms, disease recurrence was defined as asymptomatic. * First site of recurrence: isolated local recurrence, liver-only, lung-only, multiple-site, other isolated distant * Early vs. late recurrence: disease-free survival ≥12 months vs. <12 months
Treatment of PDAC recurrence
Time frame: Within a follow-up period up to 5 years
Either systemic and/or local treatment or best-supportive-care
Survival
Time frame: Within a follow-up period up to 5 years
Overall survival (from the time of resection), disease-free survival (from the time of resection), post-recurrence survival (from the time of recurrence diagnosis)
4 secondary outcomes
Presence of symptoms at time of (suspected) recurrence
Time frame: Within a follow-up period up to 5 years
Performance score at time of recurrence detection
Time frame: Within a follow-up period up to 5 years
Use of imaging procedures during follow-up
Time frame: Within a follow-up period up to 5 years
Number of histologically confirmed recurrences
Time frame: Within a follow-up period up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
Related trials for Pancreatic Ductal Adenocarcinoma
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
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.
I. Quintus Molenaar, MD, PhD principal investigator
UMC Utrecht
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 and Pancreatic Cancer, run by UMC Utrecht at 1 site in Netherlands.
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 1 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: status not confirmed, as of the sponsor's last update on 2 Feb 2023. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iris van Goor, MD (+31631917882, I.W.J.vanGoor-5@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PDAC recurrence (time frame: Within a follow-up period up to 5 years). The study lists 4 primary outcomes in all. 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 2 Feb 2023.