Clinical trial NCT03731637: A Study to Establish a New Onset Hyperglycemia and Diabetes Cohort
Official title: A Prospective Study to Establish a New Onset Hyperglycemia and Diabetes (NOD) Cohort
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes
Type2 Diabetes
Diabetes Mellitus
Keywords: New Onset Diabetes
Diabetes
Type 2 Diabetes
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
name: National Cancer Institute (NCI)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Alliance for Clinical Trials in Oncology
First posted: 2018-11-06
Enrollment: 2269
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who newly meet criteria for diabetes

Brief summary: Create a large biobank of blood samples and data from subjects with new onset hyperglycemia and diabetes (NOD).

Detailed description: A prospective NOD Cohort of 10,000 eligible, enrolled subjects will be assembled over the next 5 years, with each patient participating for up to 3 years from the date they meet biochemical (glycemic) criteria for diabetes. Sites electronic medical record databases or other avenues for recruitment, such as physician and self referral, will be utilized to identify subjects meeting criteria for NOD.

Eligibility criteria: Inclusion Criteria:

* Subject is able and willing to provide informed consent and sign an informed consent form.
* Subject must sign an authorization for the release of their protected health information.
* Subject must be ≥50 and ≤85 years of age at the time of enrollment.
* Subject must have hyperglycemia and/or diabetes as one of the following within 90 days prior to enrollment:

  * All glycemic parameters must be measured in an outpatient setting

A. (1) Hemoglobin A1c (HbA1c) ≥ 6.5% present, OR

B. Any (2) PDMs present on consecutive or simultaneous testing:

* Fasting Blood Glucose (FBG) ≥126 mg/dl
* Hemoglobin A1c (HbA1c) ≥ 6.5%
* Random Blood Glucose (RBG) ≥200 mg/dl
* 2h Post Glucose (PG) ≥200mg (11.1 mmol/L) during OGTT (oral glucose tolerance test), OR

C. Any (1) PDM present followed by an anti-diabetes medication

* Subject must have \>1 glycemic parameter measured in the 18 months prior to the elevated index lab without meeting inclusion criteria A, B, or C.
* Subject must be willing to provide blood samples (fasting) at baseline, 6, 12, and 24 months post-enrollment.
* Subject or authorized representative must be willing to complete a detailed questionnaire.

Exclusion Criteria:

* Subject must not have any past history of hyperglycemia and/or diabetes as defined by inclusion criteria A, B, or C

  * Transient diabetes (e.g. gestational and steroid-induced) is not an exclusion.
* Subject must not be on active treatment for cancer, carry a current diagnosis of any cancer, and/or investigated for suspicion of recurrence of past cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).

  * Ongoing work up for suspicion of pancreatic cancer is not an exclusion.
* Subject must not have any past history of pancreatic cancer.
* Subject must not be on anti-diabetes medications prior to the elevated index lab.
* Subject must not be on chronic or acute use of steroid medications within 90 days of the elevated index lab.

  * Allowed: Nasal, topical steroids, oral budesonide, ophthalmic
* Subject must not have had a recent (within 1 week of the elevated index lab) intra-articular steroid injection.
* In the physician's and/or investigator's judgement, subject does not have any co-morbidities that limit the subject's participation in the study.

Primary outcomes:
measure: Incidence of pancreatic ductal adenocarcinoma in new-onset hyperglycemia and diabetes
timeFrame: 3 years
measure: Determine sensitivity and specificity of serum CA 19-9 in pre-symptomatic pancreatic ductal adenocarcinoma in subjects with new-onset hyperglycemia and diabetes
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Greater Los Angeles Veterans Affairs Medical Center
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Orlando
country: United States
facility: Advent Health Translational Research Institute
state: Florida
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Univeristy Hospital, Indiana University Health
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Ypsilanti
country: United States
facility: Trinity Health Ann Arbor Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Spartanburg
country: United States
facility: Gibbs Cancer Center & Research Institute
state: South Carolina
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Marshfield
country: United States
facility: Marshfield Clinic Health System
state: Wisconsin
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Suresh Chari, MD
role: STUDY_CHAIR
affiliation: M.D. Anderson Cancer Center
name: Anirban Maitra, MBBS
role: STUDY_CHAIR
affiliation: Kaiser Permanente Southern Califorina
name: Bechien Wu, MD
role: STUDY_CHAIR
References:
citation: Chari ST, Leibson CL, Rabe KG, Ransom J, de Andrade M, Petersen GM. Probability of pancreatic cancer following diabetes: a population-based study. Gastroenterology. 2005 Aug;129(2):504-11. doi: 10.1016/j.gastro.2005.05.007.
citation: Sharma A, Smyrk TC, Levy MJ, Topazian MA, Chari ST. Fasting Blood Glucose Levels Provide Estimate of Duration and Progression of Pancreatic Cancer Before Diagnosis. Gastroenterology. 2018 Aug;155(2):490-500.e2. doi: 10.1053/j.gastro.2018.04.025. Epub 2018 Apr 30.
citation: Setiawan VW, Stram DO, Porcel J, Chari ST, Maskarinec G, Le Marchand L, Wilkens LR, Haiman CA, Pandol SJ, Monroe KR. Pancreatic Cancer Following Incident Diabetes in African Americans and Latinos: The Multiethnic Cohort. J Natl Cancer Inst. 2019 Jan 1;111(1):27-33. doi: 10.1093/jnci/djy090.
citation: Chari ST, Maitra A, Matrisian LM, Shrader EE, Wu BU, Kambadakone A, Zhao YQ, Kenner B, Rinaudo JAS, Srivastava S, Huang Y, Feng Z; Early Detection Initiative Consortium. Early Detection Initiative: A randomized controlled trial of algorithm-based screening in patients with new onset hyperglycemia and diabetes for early detection of pancreatic ductal adenocarcinoma. Contemp Clin Trials. 2022 Feb;113:106659. doi: 10.1016/j.cct.2021.106659. Epub 2021 Dec 23.