- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02309632
Pancreatic Cancer Screening of High-Risk Individuals in Arkansas
July 25, 2019 updated by: University of Arkansas
100 subjects who have a family history of pancreatic cancer (PC), or known genetic syndromes associated with increased risk of pancreatic cancer, will be followed for five years.
This data will be used to determine the pancreatic cancer and precancerous lesion detection rate in High Risk Individuals (HRIs).
Subjects may agree to annual imaging and annual biomarkers or to biomarkers only.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a family history of PC as listed below or who have one of the following syndromes: Peutz-Jeghers syndrome - STK11; BRCA 1 and 2; PALB2; ATM; FAMMM / P16; HNPCC (Lynch) / MMR genes; Hereditary pancreatitis - PRSS1
- Individuals with three or more affected blood relatives (1st, 2nd or 3rd degree)
- Individuals with two or more affected blood relatives with PC, with at least one affected FDR, should be considered for screening.
- Patients with a history of Peutz-Jeghers syndrome should be screened, regardless of family history of PC.
- Patients with a known p16 (FAMMM syndrome) with one affected 1st or 2nd degree relative will be considered for screening.
- Patients with a known BRCA1 or BRCA2 mutation with one affected 1st or 2nd degree relative should be considered for screening.
- Patients with a known PALB2 mutation with one affected family member should be considered for screening.
- Patients with a known Mismatch-repair gene-mutation carriers (Lynch syndrome) with one affected family member should be considered for screening.
Exclusion Criteria:
- Not candidates for surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Pathway 1
Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 1
|
Screening with imaging and biomarker testing
|
ACTIVE_COMPARATOR: Pathway2
Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 2
|
Screening with biomarker testing only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Detection rate of PC and precancerous lesion
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
November 1, 2015
Primary Completion (ACTUAL)
July 19, 2019
Study Completion (ACTUAL)
July 19, 2019
Study Registration Dates
First Submitted
December 3, 2014
First Submitted That Met QC Criteria
December 3, 2014
First Posted (ESTIMATE)
December 5, 2014
Study Record Updates
Last Update Posted (ACTUAL)
July 29, 2019
Last Update Submitted That Met QC Criteria
July 25, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Skin Diseases
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neurologic Manifestations
- Endocrine System Diseases
- Disease
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Endocrine Gland Neoplasms
- Genetic Diseases, Inborn
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Dyskinesias
- Neoplastic Syndromes, Hereditary
- DNA Repair-Deficiency Disorders
- Pancreatic Diseases
- Neuroendocrine Tumors
- Nevi and Melanomas
- Intestinal Polyposis
- Hyperpigmentation
- Pigmentation Disorders
- Neurocutaneous Syndromes
- Melanosis
- Cerebellar Diseases
- Primary Immunodeficiency Diseases
- Ataxia
- Spinocerebellar Ataxias
- Lentigo
- Cerebellar Ataxia
- Nevus
- Neoplasms
- Syndrome
- Colorectal Neoplasms
- Colorectal Neoplasms, Hereditary Nonpolyposis
- Pancreatic Neoplasms
- Melanoma
- Pancreatitis
- Telangiectasis
- Pancreatitis, Chronic
- Ataxia Telangiectasia
- Peutz-Jeghers Syndrome
- Dysplastic Nevus Syndrome
Other Study ID Numbers
- 203640
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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