A PAncreatic Cancer Screening Study in Individuals With New-Onset or DeteriOrating Diabetes MEllitus (PANDOME Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Early Stage Pancreatic Cancer or Precursor Lesions
研究概览
简要总结
The main goal of this study is to explore the relationship between new-onset diabetes mellitus/deteriorating diabetes and a subsequent diagnosis of pancreatic cancer. Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for pancreatic cancer.
详细描述
Individuals over 50 years of age who have developed new-onset diabetes mellitus (diagnosed within the past 12 months) or deteriorating diabetes will be recruited through the offices of primary care physicians and endocrinologists. Those meeting initial criteria will meet with a research APRN and will undergo a secondary screen to determine eligibility. Individuals enrolled in the study will undergo a five-minute psychological survey and donation of a blood sample for bio-bank analysis every 6 months for 3 years. MRI will be performed at baseline. Any abnormalities on MRI will be reviewed by a multi-disciplinary tumor board and discussed with the participant. Additional MRI will be performed on case-by-case basis
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of at least 50 years.
- •DM of Confirmed Duration: DM diagnosed within the past 12 months AND documentation of prior normal FPG, OGTT or HbA1c levels within the past 2 years. Requirement for HbA1c ≥ 6.5% OR
- •DM of Unconfirmed Duration: DM diagnosed within the past 12 months BUT no prior record of normal FPG, HbA1c or OGTT within the past 2 years. Requirement for HbA1c ≥ 7.0% OR
- •Transition from pre-Diabetes to Diabetes Mellitus within the past 12 months characterized by a change in the HbA1c of ≥ 0.5% OR
- •DM With Only One FDR: DM diagnosed within the past 12 months that is of Confirmed or Unconfirmed Duration, in an individual with 1 FDR. Requirement for HbA1c ≥ 6.5%. OR
- •Deteriorating Diabetes: DM with >2% spike in HbA1c within past 6 months confirmed with repeat testing and NOT associated with weight gain and diabetes medication non-compliance
- •ECOG Performance Status of 0-
- •No known contraindications to MRI examination or gadolinium contrast.
- •Willing to undergo MRI and screening for metal implants or metal injury.
- •Ability to provide informed consent.
- •Willing to return to study site for all study assessments.
排除标准
- •Prior history of pancreatic cancer.
- •Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years.
- •Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the disease free interval is at least 5 years).
- •Hereditary pancreatitis.
- •Use of high dose glucocorticoid steroids (at least 20 mg daily of prednisone) within 3 months of diabetes diagnosis or elevation of HbA1c. Lower doses of steroid use as a cause of glucocorticoid-induced diabetes will be made on a case-by-case basis.
- •Contraindication to MRI examination or gadolinium contrast.
- •Pregnant or nursing women.
- •Co-morbid illnesses or other concurrent disease which, in the judgment of the clinicians obtaining informed consent, would make the participant inappropriate for entry into this study.
研究组 & 干预措施
New-Onset Diabetes Mellitus
Diabetes Mellitus diagnosed within the past 12 months
干预措施: MRI/MRCP (Diagnostic Test)
Deteriorating Diabetes Mellitus
History of Diabetes Mellitus with recent deteriorating within the past 6 months confirmed with repeat testing and not associated with weight gain or diabetes medication non-compliance
干预措施: MRI/MRCP (Diagnostic Test)
结局指标
主要结局
Early Stage Pancreatic Cancer or Precursor Lesions
时间窗: Through study completion, up to 3 years
Determine incidence of pancreatic cancer or precursor lesions in individuals with new-onset diabetes mellitus or deteriorating diabetes
次要结局
- Relative Risk of Pancreatic Cancer Among Individuals with Detiorating diabetes(Through study completion, up to 3 years)
- Relative Risk of Pancreatic Cancer Among Individuals with New-Onset Diabetes(Through study completion, up to 3 years)
研究者
Richard Frank
Director of Cancer Research
Nuvance Health