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Trial record 6 of 1598 for:    Pancreatic Cancer | United States

Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT)

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ClinicalTrials.gov Identifier: NCT03460769
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : May 9, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date February 7, 2018
First Posted Date March 9, 2018
Last Update Posted Date May 9, 2019
Actual Study Start Date November 1, 2017
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 2, 2018)
Protocol and Regulatory Compliance Monitoring of Regulatory Documents for Consortium Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) [ Time Frame: 3 years ]
The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer Center will monitor protocol and regulatory compliance at all participating institutions.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03460769 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT)
Official Title Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT)
Brief Summary The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible for the coordination and data management for the Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabetes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT), which is part of the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). Similar to all studies that will be coordinated and managed by the CDMC, no patient enrollment will occur at MDACC. All patient recruitment will occur at external sites that are a part of the CPDPC, which are listed in the appended DETECT protocol. The data management systems, auditing, and monitoring effort are supported by the CDMC.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples collected at a fasting baseline (time -5 min & 0 min), then 15, 30, 45, 60, 90 and 120 minutes following meal stimulation.
Sampling Method Non-Probability Sample
Study Population Participants recruited from external sites.
Condition
  • Pancreatic Cancer
  • Chronic Pancreatitis
  • Diabetes Mellitus Type 3c
Intervention Other: Data Management and Monitoring
The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer responsible for the coordination and data management for the Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabetes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT), which is part of the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC).
Study Groups/Cohorts
  • Pancreatic Cancer
    The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible for the coordination and data management for the Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabetes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT).
    Intervention: Other: Data Management and Monitoring
  • Chronic Pancreatitis
    The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible for the coordination and data management for the Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabetes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT).
    Intervention: Other: Data Management and Monitoring
  • Type 3c Diabetes Mellitus
    The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible for the coordination and data management for the Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabetes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT).
    Intervention: Other: Data Management and Monitoring
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: March 2, 2018)
452
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

1. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must have signed an authorization for the release of their protected health information.

2 Patients must be ages ≥40 and <85.

3 Patients must have a diagnosis of one of the following based on study definitions; New Onset Diabetes in subjects with Pancreatic Cancer (PDAC); New Onset Diabetes in subjects with Chronic Pancreatitis; New Onset Diabetes in subjects without Pancreatic disease (i.e., T2DM) Long standing T2DM without Pancreatic disease Long standing diabetes in subjects with PDAC Long standing diabetes subjects with chronic pancreatitis non-diabetic subjects with PDAC non-diabetic subjects with chronic pancreatitis non-diabetic controls without Pancreatic disease

Exclusion Criteria:

  1. Patients must not have any significant medical illnesses (including diabetes) that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate study interventions. Specifically, diabetes must be stable enough to permit holding diabetes medications following the criteria below:

    The following oral anti-diabetic agents will be held on the day of the meal tolerance test but may resume once test is completed: metformin, sulfonylureas, repaglinide or nateglinide, alpha-glucosidase inhibitors (acarbose, miglitol), pramlintide, colesevelam, bromocriptine Those on low doses of insulin (< 0.5 U/kg/day) will not take insulin on the day of study procedures.

    Subjects taking higher doses of insulin (≥0.5 unit/kg/day) will be excluded from this study.

    Subjects taking, DPP-4 inhibitors, SGLT2 inhibitors, or short acting GLP-1 analogs (Byetta [exenatide], Victoza [liraglutide], Adlyxin [lixisenatide]) will be asked not to take these medications on the day of the meal tolerance test (they can be taken the day before if taken in the morning; for those taking these medications in the afternoon or evening, they will be asked to withhold such dosing on the day prior to testing).

    Subjects on longer acting agents, including thiazolidinediones and once-weekly GLP-1 agonists (Bydureon [exenatide], Tanzeum [albiglutide], Trulicity [dulaglutide]) will be excluded from the study.

  2. Patients currently receiving oral steroid medications.
  3. Hospitalization for acute pancreatitis within 2 months before study visit
  4. Presence of one or more pancreatic cysts ≥2 cm in size
  5. Any subject with a pancreatic cancer histologic subtype other than adenocarcinoma (e.g., subjects with pancreatic neuroendocrine tumors are excluded).
  6. Previous pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreaticojejunostomy, enucleation, or Frey procedure).
  7. Previous treatment for pancreatic cancer, including chemotherapy or radiation.
  8. Previous vagotomy or gastric surgery, including endoscopic gastric reduction procedures.
  9. Previous diagnosis of gastroparesis.
  10. Patients on treatment for any cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).
  11. Allergy or intolerance to ingredients in Boost drink.
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ying Yuan, PHD 713-745-9740 yyuan@mdanderson.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03460769
Other Study ID Numbers PA17-0674
1U01DK108328-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
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 Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor M.D. Anderson Cancer Center
Collaborators National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Ying Yuan, PHD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date May 2019