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Hereditary Pancreatic CancerPREPAIRDNCT05740111

The PREPAIRD Study: Personalized Surveillance for Early Detection of Pancreatic Cancer in High Risk Individuals

A study testing Annual surveillance in people with Hereditary Pancreatic Cancer, run by Oslo University Hospital at 1 site in Norway.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The objective of this national and multidisciplinary project is to establish and evaluate a personalized surveillance program (SP) for early diagnosis of pancreatic cancer (PC) and its precursors in individuals with a hereditary predisposition to the disease (High RIsk Individuals (HRI)). Read more about this study

Who is it for?
Ages 30 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Hereditary Pancreatic Cancer
What is being tested?
Annual surveillance
How many people
200 participants
Where
1 siteNorway
Study dates
1 Sep 2022to 31 Dec 2042
Phase
Interventional
Are there results?
Not yet: the study is under way

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 30 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men or women with a germline mutation in CDKN2A, TP53, PRSS1 or STK11
  • Men or women who are first degree relatives to a patient with pancreatic cancer (PC) in a family with Familial Pancreatic Cancer (FPC).
  • Exclusion Criteria: Patients undergoing active cancer treatment.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Norway1 site

  • Oslo University Hospital

    Oslo

Other trials in Norway

About this study

Official title: The PREPAIRD Study: Personalized suRveillance for Early Detection and Prevention of Pancreatic cAncer in High Risk inDividuals

The objective of this national and multidisciplinary project is to establish and evaluate a personalized surveillance program (SP) for early diagnosis of pancreatic cancer (PC) and its precursors in individuals with a hereditary predisposition to the disease (High RIsk Individuals (HRI)). Patients who either carry a germline mutation in a PC susceptibility gene (CDKN2A, STK11, TP53, PRSS1), or have a strong family history of PC, will be enrolled through their genetics clinic at the university hospitals in Oslo, Bergen, Trondheim and Tromsø. Surveillance consists of annual MRI, assessment of blood glucose and lipid levels, new onset diabetes (NOD) and unintentional weight loss. Blood samples will be drawn for ctDNA-analysis (circulating tumor DNA) and the IMMrayTM PanCan-d test (a novel microarray-based diagnostic test for PC) at baseline and in those who develop lesions. The psychological burden and cost-benefit of the SP will be analyzed. The study addresses an unmet need for the care of HRI in Norway, and is expected to improve PC prognosis. It will be the first to provide evidence on the combined value of a panel of blood-borne biomarkers in surveillance, and provide morphological and molecular data on PC and (non)-neoplastic pancreatic changes in HRI.

Being tested
Annual surveillance
Keywords
Surveillance, Early detection, Prevention
Medical subject headings
Pancreatic carcinoma, familial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Annual surveillanceOther

    Annual surveillance includes annual MRI and/or an assessment new onset diabetes and unintended weight loss.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prognosis of pancreatic cancer in patients diagnosed through the surveillance programme compared to prognosis in unscreened individuals as reported to the Cancer Registry of Norway.

    We will investigate whether 3 year, 5 year and long term survival in HRIs undergoing surveillance is improved compared to rates of survival of pancreatic cancer in the general unscreened population. Survival data for the general population will be collected from the Cancer Registry of Norway. Data on prognosis of pancreatic cancer in patients undergoing surveillance will be collected from electronic patient records, The Cancer Registry of Norway and the National Population Register.

    Measured: Up to 20 years

  2. Number of resectable cancers detected in patients diagnosed through the surveillance programme compared to the unscreened individuals as reported to the Cancer Registry of Norway.

    We will investigate whether the number of surgically resectable cancers is higher in HRIs undergoing screening through the surveillance programme compared to pancreatic cancer diagnosed in the general population of Norway. Data on number of resectable cancers in the general Norwegian population will be collected from the Cancer Registry of Norway. Data on cancers diagnosed in the HRI will be collected from electronic patient records and The Cancer Registry of Norway.

    Measured: 20 years

Secondary outcomes (10)

  1. Healthcare utilization

    Use of medication and specialist health care services. Data collected from administrative registries.

    Measured: 20 years

  2. Quality of life of participants undergoing surveillance as assessed with the Hospital Anxiety and Depression Scale (HADS)

    The quality of life of participants undergoing surveillance will be assessed with the Hospital Anxiety and Depression Scale (HADS) at baseline, after first, second and third MRI and then every three years.

    Measured: 10 years

  3. Costs

    Health care utlization will be combined with Norwegian unit costs and summarized up to 20 years.

    Measured: Up to 20 years

  4. Cost-effectiveness analysis

    Differences in costs between study population and unscreened pancreatic cancer patients in the general population. Differences in survival in the PREPAIRD-study population and pancreatic cancer patients in the general population, identified from the Cancer Registry of Norway. The health outcome is identified in primary objective one. Based on difference in costs and life years, the incremental cost-effectiveness ratio will be estimated.

    Measured: Up to 20 years

  5. Quality of life of participants undergoing surveillance as assessed with the Impact of Event Scale (IES)

    he quality of life of participants undergoing surveillance will be assessed with the Hospital Anxiety and Depression Scale (HADS) at baseline, after first, second and third MRI and then every three years.

    Measured: 10 years

  6. The cancer worry of participants undergoing surveillance as assessed with the Cancer Worry Scale

    The cancer worry of undergoing surveillance will be assessed with the Cancer Worry Scale at baseline, after first, second and third MRI and then every three years.

    Measured: 10 years

  7. The general health of participants undergoing surveillance as assessed with the General Health Questionnaire

    The cancer worry of undergoing surveillance will be assessed with the General Health Questionnaire at baseline, after first, second and third MRI and then every three years.

    Measured: 10 years

  8. The psychological consequences of undergoing screening for pancreatic cancer as assessed by the Psychological Consequences of Screening questionnaire

    The psychological consequences of undergoing screening for pancreatic cancer will be assessed with the Psychological Consequences of Screening questionnaire at baseline, after first, second and third MRI and then every three years.

    Measured: 10 years

  9. The general health of participants undergoing surveillance as assessed by the Genereal Health questionnaire

    The general health of individuals undergoing screening for pancreatic cancer will be assessed with the General Health Questionnaire at baseline, after first, second and third MRI and then every three years.

    Measured: 10 years

  10. The psychological well-being of participants undergoing surveillance as assessed by the Psychological Well-being Questionnaire

    The psychological well-being of individuals undergoing screening for pancreatic cancer will be assessed with the Psychological Well-being Questionnaire at baseline, after first, second and third MRI and then every three years.

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2023
  2. Study start1 Sep 2022
  3. Primary completion31 Dec 2042 (estimated)
  4. Study completion31 Dec 2042 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05740111
Sponsor's protocol ID
387940
Acronym
PREPAIRD
Status last verified
Feb 2023
First submitted
12 Oct 2022
Last updated
22 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Annual surveillance in people with Hereditary Pancreatic Cancer, run by Oslo University Hospital at 1 site in Norway.

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 3 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 22 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 Norway. 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?

This study is still under way. Results are not available in the source record yet.

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?

Prognosis of pancreatic cancer in patients diagnosed through the surveillance programme compared to prognosis in unscreened individuals as reported to the Cancer Registry of Norway. (time frame: Up to 20 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05740111.

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 22 Feb 2023.

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