|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
4 March 2024 |
|
Main ID: |
NCT03568630 |
|
Date of registration:
|
13/06/2018 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Blood Markers of Early Pancreas Cancer
|
|
Scientific title:
|
A Longitudinal Cohort Study to Identify Clinical and Blood Markers of Early Pancreas Cancer |
|
Date of first enrolment:
|
July 26, 2018 |
|
Target sample size:
|
1250 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT03568630 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Kelsey A Klute, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Nebraska |
|
|
Name:
|
Suzanne M Wessling, RN, BSN |
|
Address:
|
|
|
Telephone:
|
402-559-1577 |
|
Email:
|
suzanne.wessling@unmc.edu |
|
Affiliation:
|
|
|
|
Name:
|
Suzanne M Wessling, RN, BSN |
|
Address:
|
|
|
Telephone:
|
402-559-1577 |
|
Email:
|
suzanne.wessling@unmc.edu |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
General inclusion criteria:
1. Age =19
2. Able to provide written, informed consent
3. Able to to attend an in-person study visit in Omaha, NE twice a year to collect blood
samples
Exclusion Criteria:
General exclusion criteria:
1. Personal history of PDAC
2. Currently receiving treatment for a cancer diagnosis (excluding long-term hormonal
therapy)
3. Pre-diabetes on metformin for = 3 years
Age minimum:
19 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Diabetes Mellitus, Type 2
|
|
Pancreas Cyst
|
|
Inherited Disease
|
|
PreDiabetes
|
|
Chronic Pancreatitis
|
|
Genetic Predisposition to Disease
|
|
Intervention(s)
|
|
Diagnostic Test: Hemoglobin A1c
|
|
Diagnostic Test: Other exploratory blood biomarkers
|
|
Diagnostic Test: Mixed Meal Tolerance Test
|
|
Primary Outcome(s)
|
|
Number of pancreas cancer cases diagnosed.
[Time Frame: 10 years]
|
|
Result of MMTT which may indicate type 3c diabetes, which may be a risk factor for pancreas cancer.
[Time Frame: 10 years]
|
|
Biomarkers which may predict early pancreas cancer.
[Time Frame: 10 years]
|
|
Secondary ID(s)
|
|
0335-18-FB
|
|
U01CA210240-06
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|