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New Onset Diabetes Management for Earlier Detection of Pancreatic Cancer (NODMED) (NODMED)

Primary Purpose

Pancreatic Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MRI/Imaging

About this trial

This is an interventional screening trial for Pancreatic Cancer focused on measuring Early Detection, New Onset Diabetes

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

≥ 50 years of age or older at the time of enrollment

Willing to sign the informed consent form

Must have 2 occurrences from among the below parameters of diabetes mellitus (PDMs) in past 90 days measured in outpatient setting (not in urgent care, emergency room or while inpatient):

FBG ≥126mg/dl HbA1c ≥6.5% RBG ≥ 200mg/dl 2-hour post-glucose ≥200mg/dl (OGTT)

Must have had glycemic parameter measured in 3-18 months prior to screening that did NOT meet DM criteria

Must be willing to provide several tubes of blood without endangering health

No history of pancreatic cancer or other known pancreatic neoplasia

No active cancers within the past 5 years (with the exception of non-melanoma skin cancers resolved/treated > 1 year prior to enrollment and in situ cancers)

Exclusion Criteria:

Prior DM diagnosis

Met criteria for DM ≥91 days prior to enrollment (patients with prior gestational diabetes that has resolved are NOT acceptable to enroll)

Carried a DM diagnosis or used anti-DM medications at a time greater than or equal to 91 days prior to enrollment

Any known pancreatic lesions (aside from diabetes)

Received cancer treatment within the past 5 years (with the exception of treatment of non-melanoma skin cancer), carrying a current cancer diagnosis, and/or being investigated for suspicion of past cancer recurrence.

Current chronic or acute oral steroid use

History of intra-articular steroid injections (<1 week) of the qualifying DM blood test (allowed exception: nasal, topical, oral budesonide)

Any surgery requiring general anesthesia within 2 months of collection

Local anesthetic (including dental novocaine) within 1 week of collection

History or presence of HIV/AIDs, Hepatitis A or E within the past five years, TB, any kind of prion disorder (e.g., CJD)

Blood transfusion within 1 month

Organ transplant recipient

Currently pregnant, or pregnancy within last 12 months

Receipt of systemic immunomodulation therapy within past 12 months

Significant medical condition that in the site investigator's opinion would compromise the subject's ability to tolerate study interventions

Sites / Locations

Headlands Research - Scottsdale - PPDSRecruiting
JEM Research Institute - Headlands - PPDSRecruiting
Prisma Health/Endocrinology specialist and ThyroidRecruiting
Consano Clinical Research, LLCRecruiting
Manassas Clinical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Pancreatic Cancer Signal Detection = Detected

Pancreatic Cancer Signal Detection = Not Detected

Arm Description

Subjects with test results "detected" will undergo MRI/Imaging

Outcomes

Primary Outcome Measures

Positive Predictive Value (PPV)

defined as the proportion of participants with pancreatic neoplasia diagnosis out of all subjects with pancreatic signal "detected" test result.

Negative Predictive Value (NPV)

defined as the proportion of participants with no pancreatic neoplasia diagnosis out of all the subjects with pancreatic signal "not detected" test results.

Specificity

defined as the proportion of participants with pancreatic signal "not detected" results out of all subjects with no pancreatic neoplasia diagnosis.

Secondary Outcome Measures

Time to pancreatic cancer diagnosis

Median time to pancreatic cancer diagnosis (using Pancreatic Cancer Signal Detection testing) relative to new onset diabetes (NOD) diagnosis compared to Median time to pancreatic cancer diagnosis relative to NOD diagnosis in the absence of Pancreatic Cancer Signal Detection testing, based on published data

Stage Shift

Stage Shift in NODs with Pancreatic Cancer in subjects that have undergone Pancreatic Cancer Signal Detection testing vs subjects without Pancreatic Cancer Signal Detection testing

Full Information

NCT ID

NCT05188586

First Posted

December 27, 2021

Last Updated

December 6, 2022

Sponsor

ClearNote Health

1. Study Identification

Unique Protocol Identification Number

NCT05188586

Brief Title

New Onset Diabetes Management for Earlier Detection of Pancreatic Cancer (NODMED)

Acronym

NODMED

Official Title

New Onset Diabetes Management for Earlier Detection of Pancreatic Cancer (NODMED)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 6, 2022 (Anticipated)

Primary Completion Date

November 1, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ClearNote Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Bluestar Genomics has developed a non-invasive test that aids in detection of occult pancreatic cancer in patients with new onset type II diabetes (NOD) who are 50 years old or older. The purpose of this study is to evaluate the performance of Bluestar Genomics early-detection pancreatic cancer test in a clinical setting. The study is prospective, longitudinal and interventional; tests will be ordered and results returned to site-investigators. If the test returns a pancreatic cancer signal "detected" result the study participant will undergo MRI imaging to evaluate for the presence of pancreatic cancer. The study is planned to enroll 6,550 newly diagnosed type 2 diabetic subjects according to inclusion and exclusion criteria.

Detailed Description

This is a prospective longitudinal and interventional study of the Bluestar Genomics early detection pancreatic cancer test. The test will be ordered and results returned to site-investigators. The study is planned to enroll 6,550 male and female, ≥ 50 years of age and newly diagnosed with type II diabetes (within 90 days prior to enrollment). NOD subjects will be assessed for eligibility and consented. Each subject can undergo up to 2 blood draws and electronic medical record search at 12 months from diabetes diagnosis. The study population will be targeted to enroll a subjects with a BMI < 32. Subjects ≥ 50 years of age will be divided into two cohorts based on age as described below: Cohort 1 = 65 years old or older Time 0 (T0) = blood draw within 90 days of diabetes diagnosis Time 1 (T1) = blood draw 6 month draw from diabetes diagnosis Time 2 (T2) = 12 months from diabetes diagnosis, no blood draw, only medical record search for all patients for evidence of pancreatic neoplasia developed after T1. Cohort 2 = 50 - 64 years old Time 0 (T0) = blood draw within 90 days of diabetes diagnosis Time 1 (T1) = blood draw 6 month draw from diabetes diagnosis Time 2 (T2) = 12 months from diabetes diagnosis, no blood draw, only medical record search for all patients for evidence of pancreatic neoplasia developed after T1. Imaging Strategy MRI imaging (or alternate imaging if subject is unable to undergo MRI) will be performed on subjects whose test result is "detected". If the imaging study results are abnormal, the subject will be referred back to their enrolling clinician for additional diagnostic work up as part of routine healthcare. If pancreatic cancer or other pancreatic lesion is diagnosed, the diagnostic reports will be collected as part of the study clinical data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

Early Detection, New Onset Diabetes

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

6500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pancreatic Cancer Signal Detection = Detected

Arm Type

Other

Arm Description

Subjects with test results "detected" will undergo MRI/Imaging

Arm Title

Pancreatic Cancer Signal Detection = Not Detected

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

MRI/Imaging

Intervention Description

Blood collection and pancreatic cancer early detection testing with return of results.

Primary Outcome Measure Information:

Title

Positive Predictive Value (PPV)

Description

defined as the proportion of participants with pancreatic neoplasia diagnosis out of all subjects with pancreatic signal "detected" test result.

Time Frame

12 months or until diagnostic resolution

Title

Negative Predictive Value (NPV)

Description

defined as the proportion of participants with no pancreatic neoplasia diagnosis out of all the subjects with pancreatic signal "not detected" test results.

Time Frame

12 months or until diagnostic resolution

Title

Specificity

Description

defined as the proportion of participants with pancreatic signal "not detected" results out of all subjects with no pancreatic neoplasia diagnosis.

Time Frame

12 months or until diagnostic resolution

Secondary Outcome Measure Information:

Title

Time to pancreatic cancer diagnosis

Description

Time Frame

12 months or until diagnostic resolution

Title

Stage Shift

Description

Stage Shift in NODs with Pancreatic Cancer in subjects that have undergone Pancreatic Cancer Signal Detection testing vs subjects without Pancreatic Cancer Signal Detection testing

Time Frame

12 months or until diagnostic resolution

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ≥ 50 years of age or older at the time of enrollment Willing to sign the informed consent form Must have 2 occurrences from among the below parameters of diabetes mellitus (PDMs) in past 90 days measured in outpatient setting (not in urgent care, emergency room or while inpatient): FBG ≥126mg/dl HbA1c ≥6.5% RBG ≥ 200mg/dl 2-hour post-glucose ≥200mg/dl (OGTT) Must have had glycemic parameter measured in 3-18 months prior to screening that did NOT meet DM criteria Must be willing to provide several tubes of blood without endangering health No history of pancreatic cancer or other known pancreatic neoplasia No active cancers within the past 5 years (with the exception of non-melanoma skin cancers resolved/treated > 1 year prior to enrollment and in situ cancers) Exclusion Criteria: Prior DM diagnosis Met criteria for DM ≥91 days prior to enrollment (patients with prior gestational diabetes that has resolved are NOT acceptable to enroll) Carried a DM diagnosis or used anti-DM medications at a time greater than or equal to 91 days prior to enrollment Any known pancreatic lesions (aside from diabetes) Received cancer treatment within the past 5 years (with the exception of treatment of non-melanoma skin cancer), carrying a current cancer diagnosis, and/or being investigated for suspicion of past cancer recurrence. Current chronic or acute oral steroid use History of intra-articular steroid injections (<1 week) of the qualifying DM blood test (allowed exception: nasal, topical, oral budesonide) Any surgery requiring general anesthesia within 2 months of collection Local anesthetic (including dental novocaine) within 1 week of collection History or presence of HIV/AIDs, Hepatitis A or E within the past five years, TB, any kind of prion disorder (e.g., CJD) Blood transfusion within 1 month Organ transplant recipient Currently pregnant, or pregnancy within last 12 months Receipt of systemic immunomodulation therapy within past 12 months Significant medical condition that in the site investigator's opinion would compromise the subject's ability to tolerate study interventions

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Bergamaschi, PhD

Phone

650-714-9212

abergamaschi@bluestargenomics.com

First Name & Middle Initial & Last Name or Official Title & Degree

Melissa Peters, MA

mpeters@bluestargenomics.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kelly Bethel, MD

Organizational Affiliation

Bluestar Genomics

Official's Role

Principal Investigator

Facility Information:

Facility Name

Headlands Research - Scottsdale - PPDS

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85260-6411

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthew Douglas, MD

Facility Name

JEM Research Institute - Headlands - PPDS

City

Atlantis

State/Province

Florida

ZIP/Postal Code

33462-6631

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Halpert, MD

Facility Name

Prisma Health/Endocrinology specialist and Thyroid

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605-4289

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sandra Weber, MD

Facility Name

Consano Clinical Research, LLC

City

Shavano Park

State/Province

Texas

ZIP/Postal Code

78231-1281

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michelle Welch, MD

Facility Name

Manassas Clinical Research Center

City

Manassas

State/Province

Virginia

ZIP/Postal Code

20110-4421

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nabil Andrawis, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

New Onset Diabetes Management for Earlier Detection of Pancreatic Cancer (NODMED)

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