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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• 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. [Срок оценки: 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. [Срок оценки: 20 years]

Вторичные конечные точки (10)

• Healthcare utilization [Срок оценки: 20 years]
• Quality of life of participants undergoing surveillance as assessed with the Hospital Anxiety and Depression Scale (HADS) [Срок оценки: 10 years]
• Costs [Срок оценки: Up to 20 years]
• Cost-effectiveness analysis [Срок оценки: Up to 20 years]
• Quality of life of participants undergoing surveillance as assessed with the Impact of Event Scale (IES) [Срок оценки: 10 years]
• The cancer worry of participants undergoing surveillance as assessed with the Cancer Worry Scale [Срок оценки: 10 years]
• The general health of participants undergoing surveillance as assessed with the General Health Questionnaire [Срок оценки: 10 years]
• The psychological consequences of undergoing screening for pancreatic cancer as assessed by the Psychological Consequences of Screening questionnaire [Срок оценки: 10 years]
• The general health of participants undergoing surveillance as assessed by the Genereal Health questionnaire [Срок оценки: 10 years]
• The psychological well-being of participants undergoing surveillance as assessed by the Psychological Well-being Questionnaire [Срок оценки: 10 years]

Критерии участия

Критерии включения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Норвегия · 1 центр

• Oslo University Hospital — Oslo

Идентификаторы

NCT: NCT05740111 · 387940

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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