Circulating Tumor Cells in Operative Blood

February 22, 2016 updated by: University of Florida

Circulating Tumor Cells Shed in Operative Blood During Pancreatectomy for Pancreatic Cancer is Responsible for Peritoneal Recurrence

It is hypothesized that circulating tumor cells (CTCs) from pancreatic adenocarcinoma are released into the peritoneal cavity through blood lost during the surgical resection of these tumors resulting in peritoneal recurrence despite appropriate surgical resection. Targeting the mechanisms responsible for CTC adhesion to the peritoneum may result in inhibition of implantation and growth, thus preventing this mode of pancreatic cancer recurrence postoperatively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Research Plan:

Intraoperative Subjects with Pancreatic Ductal Adenocarcinoma (PDAC) who have been consented and enrolled into the study will be taken to the operating room (OR) for their previously planned pancreatectomy procedure. After general anesthesia is induced, using universal precautions, blood sample (10ml) will be collected into a heparin tube for identification of circulating tumor cells (CTCs) and serve as one of two controls designed to assess background CTC counts. Once the participant has undergone surgical exploration as planned and has been deemed a candidate for resection, normal saline will be used to wash the abdominal cavity and collected in a suction canister by the attending surgeon. Abdominal washings are a normal part of the operative procedure, typically performed at the end of the operation to wash blood out of the abdominal cavity and is performed with variable amounts depending on the surgeon's discretion. For purposes of a control for the study, this wash step will be moved to the beginning of the operation. Additional washes/irrigations may be necessary at the end of the case at the surgeon's discretion. Cells collected in this fluid will be centrifuged and collected in the lab for determination of the presence of malignant cells. This will serve as the second of two controls. As the pancreatectomy procedure proceeds, subject blood will be lost as a normal consequence of the procedure and suctioned from the operative field into a new container containing heparin chilled on ice to preserve cell viability. This blood is normally discarded at the end of the case but a portion of the blood will be collected and utilized for downstream lab experiments to detect CTCs.

Laboratory/Post-Processing Blood collected in the operating room as described above will be immediately brought to the laboratory and centrifuged to separate out the plasma, buffy coat, and erythrocytes. The buffy coat, which contains the CTCs, white blood cells, and platelets, is removed and added to the commercially available cocktail per the kit protocol. Ficoll enrichment and separation of the CTCs will then be performed. The isolated CTCs will then be used for further downstream characterization and experimentation which will include, but not limited to: identification of CTC number, growth of CTCs in vitro and in vivo, and identification/characterization of CTC adhesion molecules which allow binding to human peritoneum. Any unused blood or component of blood not utilized in the experiment will be assigned a unique identifier and de-identified of patient for future cross-reference and stored at -80 degrees Fahrenheit at the University of Florida for potential future experiments or repeat CTC isolation.

Participant Data Collection On all enrolled subjects, the following de-identified information will be collected: participant demographic data, clinical and pathologic data, and data on cancer recurrence and overall survival.

Study Type

Observational

Enrollment (Actual)

3

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

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • Shands Hospital at the University of Florida

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 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients between the ages of 18-85 years with a confirmed tissue diagnosis of pancreatic ductal adenocarcinoma who are scheduled to undergo curative surgery.

Description

Inclusion Criteria:

  • Confirmed tissue diagnosis of pancreatic ductal adenocarcinoma
  • Scheduled to undergo pancreatectomy (open or minimally invasive) with curative intent
  • Aged 18-85 years
  • No race restrictions

Exclusion Criteria:

  • Patients who have undergone preoperative therapy with either chemotherapy, radiation therapy, or both
  • Serum CA19-9 less than 200ng/ml
  • Patients with prior history of gastrointestinal malignancy

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pancreatic Cancer CTC
Peripheral/Central Venous Blood Draw Peritoneal Wash
Procedure: Peripheral/Central Venous Blood Draw
Baseline sample of whole blood to be assessed for circulating tumor cells. Samples will be acquired via venipuncture unless a pre-existing central venous catheter is in place in which case the sample will be drawn from this.
Procedure: Peritoneal Wash
Prior to the start of the surgical resection, irrigation of the abdominal cavity will be performed and collected to determine baseline pancreatic cancer cells that may be present in the abdominal cavity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with isolated circulating tumor cells
Time Frame: 2 days
2 days
Percentage of patients with successful in vivo animal engraftment of isolated circulating tumor cells
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Ryan M Thomas, MD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2015

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (ESTIMATE)

May 30, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-00271

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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