U01-Biomarkers for Noninvasive and Early Detection of Pancreatic Cancer

NCT ID: NCT03886571

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-15

Study Completion Date

2024-09-15

Brief Summary

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This is an observational, biospecimen collection protocol to develop a bank of pancreatic cancer tissue and normal tissue.

Detailed Description

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This is an observational, biospecimen collection protocol to develop a bank of pancreatic cancer tissue, normal tissue. Biospecimens collected through this protocol will be shared with collaborators in the Pancreatic Cancer Detection Consortium to support projects funded through an NIH U01 grant. Participants will be enrolled when they present for clinically indicated surgical procedures for their possible tumor or pancreas resection or cyst resection, or at a clinically indicated follow-up appointment after their procedure.

This protocol supports this effort by providing investigators with access to a wide variety of pancreatic tissues and biospecimens for translational studies in pancreatic cancer. This protocol covers the collection of clinical data and biospecimens (blood; malignant, benign, or precancerous pancreatic tumor; and adjacent normal tissues) from patients with, or suspected to have, pancreatic cancer. Additionally, saliva and cyst fluid, may be collected in the future from patients with pancreatic cysts. These will be shared with the Pancreatic Cancer Detection Consortium for further analysis.

Conditions

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Pancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Males or Females ≥ 18 years of age who have been diagnosed with Pancreatic Cancer (PDAC), Pancreatic Neoplasms (PNs - IPMMs, PanINs and MCNs), pancreatitis and diabetes or no disease/healthy.
* Individuals undergoing or have previously undergone a diagnostic procedure (i.e. EUS or ERCP) evaluation or surgery.
* Willingness and ability to donate biospecimens for the purpose of research.
* Subjects must have had diagnostic procedure or surgery after September 1, 2017.

Exclusion Criteria

* Individuals under 18 years of age.
* Inability to donate biospecimens.
* Females pregnant or lactating.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor Research Institute

OTHER

Sponsor Role collaborator

Hoag Memorial Hospital Presbyterian

OTHER

Sponsor Role lead

Responsible Party

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Michael Demeure, MD

Program Director for Precision Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Leila Andres, MS

Role: CONTACT

949-764-5543

Facility Contacts

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Leila Andres, MS

Role: primary

949-764-5543

Other Identifiers

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119-17-CA

Identifier Type: -

Identifier Source: org_study_id

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