RECRUITING

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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Conditions

Pancreatic CancerChronic PancreatitisDiabetes Mellitus Type 3cData management

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2021-04-01
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03460769

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 84 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must be ages ≥30 and \<85.
  2. * Patients must have a diagnosis of one of the following based on study definitions
  3. * New Onset Diabetes (\<3 years) in subjects with Pancreatic Cancer (PDAC);
  4. * New Onset Diabetes (\<3 years) in subjects with Chronic Pancreatitis;
  5. * New Onset Diabetes (\<3 years) in subjects without Pancreatic disease (i.e., T2DM)
  6. * Long standing T2DM (≥3 years) without Pancreatic disease
  7. * Long standing diabetes (≥3 years) in subjects with PDAC
  8. * Long standing diabetes (≥3 years) subjects with chronic pancreatitis
  9. * non-diabetic subjects with PDAC
  10. * non-diabetic subjects with chronic pancreatitis
  11. * non-diabetic controls without Pancreatic disease
  1. * Subjects 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.
  2. * Diabetes not stable enough to permit holding of diabetes medications in subjects undergoing mixed meal tolerance testing.
  3. * Subjects taking higher doses of insulin (≥0.75 unit/kg/day).
  4. * Subjects in the non-pancreatic disease subgroup (i.e., T2DM) on longer acting agents, including thiazolidinediones and once-weekly GLP-1 agonists (Bydureon \[exenatide\], Ozempic \[semaglutide\], Trulicity \[dulaglutide\]). Conversely, the use of these medications is permitted for subjects in the CP and PDAC groups.
  5. * Patients currently receiving oral steroid medications.
  6. * Hospitalization for acute pancreatitis within 2 months before study visit (with the exception of subjects enrolled into the PDAC group, as this may be a symptom of the disease).
  7. * The presence of a symptomatic cyst in subjects with CP. The presence of a cyst in subjects with pancreatic cancer is not an exclusion, including cancer arising from a mucinous cystic lesion.
  8. * Any subject with a known pancreatic cancer histologic subtype other than adenocarcinoma (e.g., subjects with pancreatic neuroendocrine tumors are excluded).
  9. * Previous pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreaticojejunostomy, enucleation, or Frey procedure). An exception to this criterion are subjects with CP who had a history of surgery (including pancreaticoduodenectomy, pancreatic ojejunostomy, distal pancreatectomy, or Frey).
  10. * Previous treatment for pancreatic cancer, including chemotherapy or radiation.
  11. * Previous vagotomy or gastric surgery, including endoscopic gastric reduction procedures.
  12. * Previous diagnosis of gastroparesis.
  13. * Patients on treatment for any cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).
  14. * Allergy or intolerance to ingredients in Boost drink in subjects undergoing mixed meal testing

Contacts and Locations

Study Contact

Ying Yuan, PHD
CONTACT
713-745-9740
yyuan@mdanderson.org
Suresh Chari, MBBS
CONTACT
713-501-3714
stchari@mdanderson.org

Principal Investigator

Suresh Chari, MBBS
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Suresh Chari, MBBS, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-01
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2021-04-01
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • Pancreatic Cancer
  • Chronic Pancreatitis
  • Diabetes Mellitus Type 3c
  • Data management

Additional Relevant MeSH Terms

  • Pancreatic Cancer
  • Chronic Pancreatitis
  • Diabetes Mellitus Type 3c