DiabetesNODNCT03731637
A Study to Establish a New Onset Hyperglycemia and Diabetes Cohort
An observational study of Diabetes and Type2 Diabetes, run by Fred Hutchinson Cancer Center at 18 sites in United States.
Trial summary
Create a large biobank of blood samples and data from subjects with new onset hyperglycemia and diabetes (NOD). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Diabetes, Type2 Diabetes, Diabetes Mellitus
- How many people
- 2,269 participants
- Where
- 18 sitesUnited States
- Study dates
- 15 Oct 2018to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who newly meet criteria for diabetes
Who may be able to join
- 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
- (1) Hemoglobin A1c (HbA1c) ≥ 6.5% present, OR
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- 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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Henry Ford Health System
Detroit, Michigan, 48202
University of Florida
Gainesville, Florida, 32608
Baylor College of Medicine
Houston, Texas, 77030
Univeristy Hospital, Indiana University Health
Indianapolis, Indiana, 46202
Kaiser Permanente Southern California
Los Angeles, California, 90027
Cedars Sinai Medical Center
Los Angeles, California, 90048
Greater Los Angeles Veterans Affairs Medical Center
Los Angeles, California, 90073
Marshfield Clinic Health System
Marshfield, Wisconsin, 54449
Ochsner Medical Center
New Orleans, Louisiana, 70121
Kaiser Permanente Northern California
Oakland, California, 94612
Advent Health Translational Research Institute
Orlando, Florida, 32804
Stanford University Medical Center
Palo Alto, California, 94605
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
Gibbs Cancer Center & Research Institute
Spartanburg, South Carolina, 29303
Carle Foundation Hospital
Urbana, Illinois, 61801
Trinity Health Ann Arbor Hospital
Ypsilanti, Michigan, 48197
About this study
Official title: A Prospective Study to Establish a New Onset Hyperglycemia and Diabetes (NOD) Cohort
Create a large biobank of blood samples and data from subjects with new onset hyperglycemia and diabetes (NOD).
Read the 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.
- Conditions
- Diabetes, Type2 Diabetes, Diabetes Mellitus
- Keywords
- New Onset Diabetes, Diabetes, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| New-onset diabetes | Subjects with biochemically-defined new-onset diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pancreatic ductal adenocarcinoma in new-onset hyperglycemia and diabetes
Enrolled subjects will be followed for three years to determine the 1-year, 2-year, 3-year incidence rates of PDAC in new-onset hyperglycemia and diabetes.
Measured: 3 years
Determine sensitivity and specificity of serum CA 19-9 in pre-symptomatic pancreatic ductal adenocarcinoma in subjects with new-onset hyperglycemia and diabetes
We will retrospectively measure serum CA 19-9 in blood collected at baseline and at each subsequent blood draw to determine its ability to predict pancreatic cancer in presymptomatic subjects. We will also collect blood for future biomarker testing.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start15 Oct 2018
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Why it stopped: Low recruitment rate and low event rate (pancreatic cancer).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, National Cancer Institute (NCI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Alliance for Clinical Trials in Oncology
- Responsible party
- Principal investigator, Ziding Feng, Fred Hutchinson Cancer Center
- Investigators
- Suresh Chari, MD, Study chair, M.D. Anderson Cancer CenterAnirban Maitra, MBBS, Study chair, M.D. Anderson Cancer CenterBechien Wu, MD, Study chair, Kaiser Permanente Southern Califorina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731637
- Sponsor's protocol ID
- 17-011305
- Other IDs
- U01DK108328, A211701, NCI-2018-01307, RG1001811
- Acronym
- NOD
- Status last verified
- Apr 2025
- First submitted
- 1 Nov 2018
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16083707Sharma 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.
PubMed 29723506Setiawan 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.
PubMed 29917105Chari 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.
PubMed 34954100
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Establish a New Onset Hyperglycemia and Diabetes (NOD) Cohort
- ClinicalTrials.gov ID
- NCT03731637
- Acronym / sponsor ID
- NOD / 17-011305
- Conditions
- Diabetes, Type2 Diabetes, Diabetes Mellitus
- Keywords
- New Onset Diabetes, Diabetes, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low recruitment rate and low event rate (pancreatic cancer).
- Enrolment
- 2,269 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, National Cancer Institute (NCI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Alliance for Clinical Trials in Oncology
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New-onset diabetes | – | –Subjects with biochemically-defined new-onset diabetes |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who newly meet criteria for diabetes
Key inclusion criteria (15 listed)
- 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:
- (1) Hemoglobin A1c (HbA1c) ≥ 6.5% present, OR
Key exclusion criteria (10 listed)
- Subject must not have any past history of hyperglycemia and/or diabetes as defined by inclusion criteria A, B, or C
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of pancreatic ductal adenocarcinoma in new-onset hyperglycemia and diabetes
Time frame: 3 years
Enrolled subjects will be followed for three years to determine the 1-year, 2-year, 3-year incidence rates of PDAC in new-onset hyperglycemia and diabetes.
Determine sensitivity and specificity of serum CA 19-9 in pre-symptomatic pancreatic ductal adenocarcinoma in subjects with new-onset hyperglycemia and diabetes
Time frame: 3 years
We will retrospectively measure serum CA 19-9 in blood collected at baseline and at each subsequent blood draw to determine its ability to predict pancreatic cancer in presymptomatic subjects. We will also collect blood for future biomarker testing.
Results and safety
The study was stopped early (reason given: Low recruitment rate and low event rate (pancreatic cancer).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Results publication: PubMed 16083707Chari 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.
- Results publication: PubMed 29723506Sharma 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.
- Results publication: PubMed 29917105Setiawan 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.
- Derived from this study: PubMed 34954100Chari 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suresh Chari, MD study chair
M.D. Anderson Cancer Center
Anirban Maitra, MBBS study chair
M.D. Anderson Cancer Center
Bechien Wu, MD study chair
Kaiser Permanente Southern Califorina
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Type2 Diabetes, run by Fred Hutchinson Cancer Center at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruitment rate and low event rate (pancreatic cancer).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pancreatic ductal adenocarcinoma in new-onset hyperglycemia and diabetes (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03731637, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.