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

Hereditary Pancreatic Cancer Clinical Trial

— PREPAIRD  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05740111
• Other study ID #: 387940
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2042

Study information

• Verified date: February 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)). 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2042
• Est. primary completion date: December 31, 2042
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Men or women with a germline mutation in CDKN2A, TP53, PRSS1 or STK11

2. 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.

Related Conditions & MeSH terms

• Hereditary Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (9)

Lead Sponsor	Collaborator
Oslo University Hospital	Haukeland University Hospital, Helse Sor-Ost, Helse Stavanger HF, Immunovia, Inc., St. Olavs Hospital, University Hospital of North Norway, University of Bergen, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 20 years
Primary	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.	20 years
Secondary	Healthcare utilization	Use of medication and specialist health care services. Data collected from administrative registries.	20 years
Secondary	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.	10 years
Secondary	Costs	Health care utlization will be combined with Norwegian unit costs and summarized up to 20 years.	Up to 20 years
Secondary	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.	Up to 20 years
Secondary	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.	10 years
Secondary	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.	10 years
Secondary	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.	10 years
Secondary	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.	10 years
Secondary	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.	10 years
Secondary	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.	10 years