NCT05692596

Brief Summary

The long-term goal of our PIC is to develop effective strategies that can be applied clinically at the point-of-care to prevent, intercept, or detect PDAC at an early stage, thereby reducing PDAC burden and saving lives.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
317

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Oct 2022Jul 2026

Study Start

First participant enrolled

October 6, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

3.7 years

First QC Date

January 11, 2023

Last Update Submit

March 31, 2026

Conditions

Keywords

pancreasdatabase

Outcome Measures

Primary Outcomes (1)

  • Database creation

    A centralized, real-time, queryable and secure database will be developed that will integrate data on Moffitt patients diagnosed with pancreatic ductal adenocarcinoma (PDAC), pancreatic cystic lesions (benign, pre-cancerous and malignant), or an inherited PDAC susceptibility.

    24 months

Study Arms (1)

All participants

Participants include patients scheduled to see the clinical team in the Pancreas Interception Center (PIC) which will be housed in the Moffitt GI Clinic.

Other: Data collection

Interventions

Investigators will compile data typically collected clinically. This data will include demographics, cancer screening procedures, cancer diagnosis and staging, chemotherapy, immunotherapy, radiation therapy, surgery, comorbidities, medication use, lifestyle and other cancer risk factors, quality of life, vital status, and molecular data generated from specimens collected clinically.

All participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting at the Moffitt GI clinic

You may qualify if:

  • years of age or older
  • Moffitt Cancer Center patients presenting with a pancreatic cyst, and/or inherited syndrome that predisposes them to pancreatic ductal adenocarcinoma (PDAC)
  • Moffitt Cancer Center patients undergoing evaluation for localized/early stage PDAC.
  • Moffitt Cancer Center patients with a combination of PDAC risk factors such as a history of chronic or new-onset diabetes, pancreatitis, obesity, tobacco exposure, toxin exposure and/or heavy alcohol consumption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33617, United States

Location

Related Links

MeSH Terms

Conditions

Pancreatic CystPancreatitis, ChronicColorectal Neoplasms, Hereditary NonpolyposisDysplastic Nevus SyndromePeutz-Jeghers SyndromeAtaxia Telangiectasia

Interventions

Data Collection

Condition Hierarchy (Ancestors)

CystsNeoplasmsPancreatic DiseasesDigestive System DiseasesPancreatitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic DiseasesNevusNevi and MelanomasNeoplasms by Histologic TypeIntestinal PolyposisLentigoMelanosisHyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue DiseasesSpinocerebellar AtaxiasCerebellar AtaxiaCerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocutaneous SyndromesAtaxiaDyskinesiasNeurologic ManifestationsTelangiectasisVascular DiseasesCardiovascular DiseasesPrimary Immunodeficiency DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Shaffer Mok, MD, MBS

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 20, 2023

Study Start

October 6, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations