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EpiDetect Study: Clinical Validation of a Pancreatic Cancer Detection Test in New-Onset Diabetes Patients

Primary Purpose

Pancreatic Cancer

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Early detection pancreatic cancer test

Early detection pancreatic cancer test and MRI Imaging

About this trial

This is an interventional screening trial for Pancreatic Cancer focused on measuring Pancreatic cancer; Early pancreatic cancer detection

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 provide and 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 without meeting DM criteria
Must be willing to provide several tubes of blood without endangering health
No history of pancreatic cancer
No history of IPMNs, other neoplastic cysts and pancreatitis
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 carcinomas)

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
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

Bluestar Genomics, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

EpiDetect Arm

EpiDetect "not detected" MRI Arm

Arm Description

Each subject can undergo to up to 3 blood draws; at the time of enrollment (T0), at 6 months (T1) and 12 months (T2) from diabetes diagnosis. After 24 months from diabetes diagnosis, a review of the electronic medical records (EMR) will be performed for all subjects with a "not detected" test result.

A pre-specified number of cases with test results "not detected" will be randomly selected, gender ratio and age matched to subjects with test results "detected" and will undergo MRI imaging at T0 (n=226), at T1 (n=208 ) at T2 (n=208 ) and 24 months (n=208) from diabetes diagnosis.

Outcomes

Primary Outcome Measures

Clinical performance of test: pancreatic cancer sensitivity

Test sensitivity (Sn) for histopathology confirmed pancreatic cancer (ground truth)

Clinical performance of test: IPMNs sensitivity

Test sensitivity (Sn) for intraductal papillary mucinous neoplasms (IPMNs)

Clinical performance of test: Specificity

Test specificity (Sp) for pancreatic neoplasia.

Secondary Outcome Measures

Positive Predictive Value

PPV for pancreatic neoplasia

Negative Predictive Value

NPV

Stage Shift

Evaluation of stage at diagnosis

Full Information

NCT ID

NCT05188573

First Posted

December 27, 2021

Last Updated

December 27, 2021

Sponsor

ClearNote Health

1. Study Identification

Unique Protocol Identification Number

NCT05188573

Brief Title

EpiDetect Study: Clinical Validation of a Pancreatic Cancer Detection Test in New-Onset Diabetes Patients

Official Title

EpiDetect Study: Clinical Validation of a Pancreatic Cancer Detection Test in New-Onset Diabetes Patients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 1, 2022 (Anticipated)

Primary Completion Date

March 31, 2025 (Anticipated)

Study Completion Date

May 31, 2025 (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

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

Bluestar Genomics has developed a non-invasive test that aids in the qualitative 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 validate the performance of Bluestar Genomics early-detection pancreatic cancer test. The study is prospective, longitudinal and interventional; tests will be ordered and results returned to site-investigators. If the assay 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 10,000 newly diagnosed type II 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 10,000 male and female, ≥ 50 years of age and newly diagnosed with type II diabetes (within 90 days prior to enrollment). The study population will target 70% of subjects over 65 years old, 53% males and will target to enroll at least 50% of subjects with a BMI <32. Each subject can undergo to up to 3 blood draws; at the time of enrollment (T0), at 6 months (T1) and 12 months (T2) from diabetes diagnosis. If test result is "detected", MRI imaging will be performed to further assess the pancreas. If the MRI 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. After 24 months from diabetes diagnosis, a review of the electronic medical records (EMR) will be performed for all subjects with a "not detected" test result. The study will also include an Bluestar Genomics's test "not detected" imaging arm (negative control imaging arm) for each time point. Subjects included in the negative imaging arm will be pre-specified and randomly selected among the Bluestar Genomics "not detected" cases gender ratio and age matched to Bluestar Genomics "detected" and will undergo MRI imaging.

6. Conditions and Keywords

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

Pancreatic Cancer

Keywords

Pancreatic cancer; Early pancreatic cancer detection

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EpiDetect Arm

Arm Type

Experimental

Arm Description

Arm Title

EpiDetect "not detected" MRI Arm

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Early detection pancreatic cancer test

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Early detection pancreatic cancer test and MRI Imaging

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical performance of test: pancreatic cancer sensitivity

Description

Test sensitivity (Sn) for histopathology confirmed pancreatic cancer (ground truth)

Time Frame

24 months or until diagnostic resolution

Title

Clinical performance of test: IPMNs sensitivity

Description

Test sensitivity (Sn) for intraductal papillary mucinous neoplasms (IPMNs)

Time Frame

24 months or until diagnostic resolution

Title

Clinical performance of test: Specificity

Description

Test specificity (Sp) for pancreatic neoplasia.

Time Frame

24 months or until diagnostic resolution

Secondary Outcome Measure Information:

Title

Positive Predictive Value

Description

PPV for pancreatic neoplasia

Time Frame

24 months or until diagnostic resolution

Title

Negative Predictive Value

Description

NPV

Time Frame

24 months or until diagnostic resolution

Title

Stage Shift

Description

Evaluation of stage at diagnosis

Time Frame

24 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 provide and 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 without meeting DM criteria Must be willing to provide several tubes of blood without endangering health No history of pancreatic cancer No history of IPMNs, other neoplastic cysts and pancreatitis 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 carcinomas) 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 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

Judy Sheard, MPH, CCRA

Phone

858-342-4493

jsheard@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

Bluestar Genomics, Inc.

City

San Diego

State/Province

California

ZIP/Postal Code

92121

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

EpiDetect Study: Clinical Validation of a Pancreatic Cancer Detection Test in New-Onset Diabetes Patients

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