NCT05740111

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
203mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Sep 2022Dec 2042

Study Start

First participant enrolled

September 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
19.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2042

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2042

Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

20.3 years

First QC Date

October 12, 2022

Last Update Submit

February 13, 2023

Conditions

Hereditary Pancreatic Cancer

Keywords

SurveillanceEarly detectionPrevention

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (10)

  • Healthcare utilization

    20 years

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

    10 years

  • Costs

    Up to 20 years

  • Cost-effectiveness analysis

    Up to 20 years

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

    10 years

  • +5 more secondary outcomes

Interventions

Annual surveillanceOTHER

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

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Pancreatic carcinoma, familial

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Section for Hereditary Cancer

Study Record Dates

First Submitted

October 12, 2022

First Posted

February 22, 2023

Study Start

September 1, 2022

Primary Completion (Estimated)

December 31, 2042

Study Completion (Estimated)

December 31, 2042

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations

NO(1)