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出境医 / 临床实验 / A Pancreatic Cancer Screening Study in Individuals With New-Onset Diabetes Mellitus

A Pancreatic Cancer Screening Study in Individuals With New-Onset Diabetes Mellitus

Study Description
Brief Summary:
The main goal of this study is to explore the relationship between new-onset diabetes mellitus 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.

Condition or disease Intervention/treatment
Pancreatic Cancer Pancreatic Neoplasms Diagnostic Test: MRI/MRCP

Detailed Description:
Individuals between 50-80 years of age who have developed diabetes mellitus within the preceding year will be recruited through the offices of primary care physicians and endocrinologists. Those meeting initial criteria will meet with a research nurse 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 annually for 2 years (3 in total). Any abnormalities on MRI will be reviewed by a multi-disciplinary tumor board and discussed with the participant.
Study Design
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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pancreatic Cancer Screening Study in Individuals With New-Onset Diabetes Mellitus
Actual Study Start Date : January 19, 2018
Estimated Primary Completion Date : January 19, 2028
Estimated Study Completion Date : January 19, 2028
Arms and Interventions
Group/Cohort Intervention/treatment
New-Onset Diabetes Mellitus
Diabetes Mellitus diagnosed within the past 12 months
 Diagnostic Test: MRI/MRCP
An MRI/MRCP with IV gadolinium contrast with high resolution imaging of the pancreas will be performed annually
Outcome Measures
Primary Outcome Measures :
  1. Early Stage Pancreatic Cancer or Precursor Lesions [ Time Frame: Through study completion, up to 3 years ]
    Determine incidence of pancreatic cancer or precursor lesions within a population of new-onset diabetes mellitus individuals


Secondary Outcome Measures :
  1. Relative Risk of Pancreatic Cancer Among Individuals with New-Onset Diabetes [ Time Frame: Through study completion, up to 3 years ]
    Assess utility of MRI as a screening tool for pancreatic cancer and ascertain relative risk of pancreatic cancer in study population of individuals with new-onset diabetes compared to a normal population of the same age


Biospecimen Retention:   Samples With DNA
Serum sample

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
50-80 years of age. New-onset diabetes mellitus (diagnosed with within the preceding 12 months)
Criteria

Inclusion Criteria:

  • Age between 50-80 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%.
  • ECOG Performance Status of 0-1.
  • No known contraindications to MRI examination or gadolinium contrast.
  • Willing to undergo MRI and screening for metal implants or metal injury.
  • Recent BUN and Cr
  • Estimated GFR (eGFR) must be greater than 40 mL/min.
  • Ability to provide informed consent.
  • Willing to return to study site for all study assessments.

Exclusion Criteria:

  • 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.
  • eGFR < 40 mL/min.
  • 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.
Contacts and Locations

Contacts
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Contact: Tammy Lo, APRN 203-822-3551 Tammy.Lo@wchn.org
Contact: Pramila Krumholtz, RN 203-739-7997 Pramila.Krumholtz@wchn.org

Locations
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United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06511
Contact: James Farrell, MD       James.J.Farrell@yale.edu   
Principal Investigator: James Farrell, MD         
Western Connecticut Health Network Recruiting
Norwalk, Connecticut, United States, 06856
Contact: Tammy Lo, APRN    203-822-3551    Tammy.Lo@wchn.org   
Principal Investigator: Richard Frank, MD         
Sponsors and Collaborators
Nuvance Health
Yale University
Investigators
Layout table for investigator information
Principal Investigator: Richard Frank, MD Nuvance Health
Tracking Information
First Submitted Date April 5, 2019
First Posted Date May 3, 2019
Last Update Posted Date October 8, 2020
Actual Study Start Date January 19, 2018
Estimated Primary Completion Date January 19, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 2, 2019) 		Early Stage Pancreatic Cancer or Precursor Lesions [ Time Frame: Through study completion, up to 3 years ]
Determine incidence of pancreatic cancer or precursor lesions within a population of new-onset diabetes mellitus individuals
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 2, 2019) 		Relative Risk of Pancreatic Cancer Among Individuals with New-Onset Diabetes [ Time Frame: Through study completion, up to 3 years ]
Assess utility of MRI as a screening tool for pancreatic cancer and ascertain relative risk of pancreatic cancer in study population of individuals with new-onset diabetes compared to a normal population of the same age
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Pancreatic Cancer Screening Study in Individuals With New-Onset Diabetes Mellitus
Official Title A Pancreatic Cancer Screening Study in Individuals With New-Onset Diabetes Mellitus
Brief Summary The main goal of this study is to explore the relationship between new-onset diabetes mellitus 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.
Detailed Description Individuals between 50-80 years of age who have developed diabetes mellitus within the preceding year will be recruited through the offices of primary care physicians and endocrinologists. Those meeting initial criteria will meet with a research nurse 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 annually for 2 years (3 in total). Any abnormalities on MRI will be reviewed by a multi-disciplinary tumor board and discussed with the participant.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum sample
Sampling Method Probability Sample
Study Population 50-80 years of age. New-onset diabetes mellitus (diagnosed with within the preceding 12 months)
Condition
  • Pancreatic Cancer
  • Pancreatic Neoplasms
Intervention Diagnostic Test: MRI/MRCP
An MRI/MRCP with IV gadolinium contrast with high resolution imaging of the pancreas will be performed annually
Study Groups/Cohorts New-Onset Diabetes Mellitus
Diabetes Mellitus diagnosed within the past 12 months
Intervention: Diagnostic Test: MRI/MRCP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 2, 2019) 		800
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 19, 2028
Estimated Primary Completion Date January 19, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age between 50-80 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%.
  • ECOG Performance Status of 0-1.
  • No known contraindications to MRI examination or gadolinium contrast.
  • Willing to undergo MRI and screening for metal implants or metal injury.
  • Recent BUN and Cr
  • Estimated GFR (eGFR) must be greater than 40 mL/min.
  • Ability to provide informed consent.
  • Willing to return to study site for all study assessments.

Exclusion Criteria:

  • 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.
  • eGFR < 40 mL/min.
  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Tammy Lo, APRN 203-822-3551 Tammy.Lo@wchn.org
Contact: Pramila Krumholtz, RN 203-739-7997 Pramila.Krumholtz@wchn.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03937453
Other Study ID Numbers 18-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: De-identified participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data will be available within 6 months of study completion
Access Criteria: Data access requests will be reviewed on an individual basis post submission. Requestors may be required to sign a data access agreement
Responsible Party Richard Frank, Nuvance Health
Study Sponsor Nuvance Health
Collaborators Yale University
Investigators
Principal Investigator: Richard Frank, MD Nuvance Health
PRS Account Nuvance Health
Verification Date October 2020

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