Cultured Circulating Tumor Cells in Prostate and Other Cancers

January 15, 2015 updated by: Oscar Goodman, Jr.

Cultured Circulating Tumor Cells - Development of a Novel Platform for Drug Discovery and in Vitro Chemosensitivity Testing in Prostate and Other Cancers

The purpose of this study is to evaluate the number of circulating tumor cells (CTC) before and after treatment using an experimental method for detecting CTC, compared to commercial CTC assay results, in patients with prostate, breast or colorectal cancers.

Experiments will be done to develop a new assay technique and also test how CTC react to commonly used drugs. This information will be analyzed to determine if the experimental assays can be helpful in the future to predict how a patient's cancer may react to certain treatments.

The research experiments will also attempt to grow CTC for long-term or "immortal" cell lines that can be further studied for proteins and gene mutations related to the specific tumor (not familial), and testing for sensitivity to drugs.

Blood samples will be collected at specific time points during routine medical care from patients with prostate, breast, colorectal or other solid tumor cancer. Samples will also be collected from patients with no cancer for comparison purposes. Samples for the experimental tests will be identified only by codes and results will not be shared with participants. Patients with prostate, breast or colorectal cancer will also have blood samples drawn for commercial CTC assays as part of their standard care.

Study Overview

Status

Unknown

Conditions

Detailed Description

Prostate cancer is the most common cancer in men, with the exception of non-melanomatous skin cancer, and the second leading cause of cancer death among men. According to the Center for Disease Control and United States Cancer Statistics (USCS), in the year 2007 there were 29,093 deaths caused by prostate cancer, and 223,307 men were newly diagnosed with the disease in the United States Given the clinical heterogeneity of this disease as well as the toxicities of current therapies, new prognostic and predictive biomarkers are much needed to facilitate informed therapeutic decision making.

A strong correlation between the CTC and the progression of breast, colon and prostate cancers has been demonstrated, being both prognostic and predictive of response to therapy and overall survival. The use of the Veridex CellSearch™ CTC assay has been approved by the FDA to monitor breast and colon cancer therapy. CTCs are a standard of care for monitoring response to prostate cancer treatment, as well. It is likely that changes in the number of CTCs may also be a predictive indicator of treatment response.

Techniques utilized in the Veridex Cellsearch™ severely damage CTC in the process, removing the possibility for further study and characterization of the CTC. This study will attempt to improve upon the technology by developing and testing a novel strategy for isolation of intact and viable CTCs, and compare the results to the CellSearch™ benchmark. CTC Development of short or long-term cell lines from these samples would greatly facilitate further characterization of metastasis-producing cells from individual patients. For example, this may allow identification of somatic gene mutations (e.g. in AR) that predict drug therapy responses, global gene and protein expression patterns, drug sensitivity and resistance testing.

Following informed consent, all patients will have two 7.5 cc samples of blood drawn at a time when routine blood work related to disease monitoring or treatment is drawn. In addition, those patients with a diagnosis of breast cancer, prostate cancer, or colorectal cancer will have an additional 10cc drawn into a CellSave tube for standard of care CellSearch™ CTC enumeration if their insurance covers the cost. Additional samples will be obtained from selected patients during or following treatment to monitor disease progression or treatment response.

Samples will be de-identified and sent to Dr. Goodman's laboratory at Roseman University of Health Sciences. Samples will be processed and results entered into a password-protected database. Results of experiments on the research samples will not be shared with the patient. Results from the CellSearch™ CTC assay will be de-identified by an honest broker and entered into the database. Patient information will also be collected, de-identified and entered into the database. Information will include age, gender, tumor status (TNM), serum LDH, other pertinent standard of care tumor markers (PSA, CEA, or CA 27-29, if available), date of tumor diagnosis, treatment history, date of regional and metastatic progression and date of death (if applicable).

Study Type

Observational

Enrollment (Anticipated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be having blood drawn at Comprehensive Cancer Centers of Nevada as part of their routine care.

Description

Inclusion Criteria:

  • Diagnosis of prostate cancer, breast cancer, or other cancer, OR have no cancer. All participants will be having blood drawn at Comprehensive Cancer Centers of Nevada as part of their routine care.
  • 18 years of age or older.
  • All participants must be informed of the investigational nature of this study, and must sign and give written informed consent in accordance with institutional and FDA guidelines.

Exclusion Criteria:

-

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
Breast Cancer
Colorectal Cancer
Prostate Cancer
Solid Tumor
Benign Condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate novel CTC assay method as a predictive tool for prostate, breast and colorectal cancers.
Time Frame: Completed within 12 months after last sample collected.
Colony counts will be assessed using a novel 3-D assay and a commercial CTC count method (CellSearch™). Samples will be collected prior to and post initiation of treatment. Results will be evaluated for changes in CTC counts.
Completed within 12 months after last sample collected.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity comparison
Time Frame: Baseline, post treatment (up to 12 months)
Results of the novel 3-D assay technique will be compared with results of the commercial CellSearch™ assay for patients with breast, prostate or colon cancer. Results will be evaluated for sensitivity and specificity for the particular cancer.
Baseline, post treatment (up to 12 months)
Develop in vitro assay for chemotherapy sensitivity testing
Time Frame: Baseline, post treatment (up to 12 months)
CTC will be tested for sensitivity to select drug and biologic agents with the aim to develop a useful sensitivity assay.
Baseline, post treatment (up to 12 months)
IC50 correlation with CTC response and clinical outcome
Time Frame: Baseline, post treatment (up to 12 months)
IC50 will be determined for each patient. Exploratory analyses will be performed to determine if in vitro efficacy correlates with observed CTC counts and clinical outcome.
Baseline, post treatment (up to 12 months)
Attempt growth of long-term tumor cell lines for evaluation
Time Frame: Baseline, post treatment (up to 12 months)
In samples that experience extensive CTC growth, attempts will be made to culture cell lines over the long term in flasks using culture medium and standard tissue culture approaches.
Baseline, post treatment (up to 12 months)

Collaborators and Investigators

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

Sponsor

Oscar Goodman, Jr.

Collaborators

Roseman University of Health Sciences
Comprehensive Cancer Centers of Nevada

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

April 1, 2014

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

February 3, 2014

First Submitted That Met QC Criteria

April 24, 2014

First Posted (Estimate)

April 28, 2014

Study Record Updates

Last Update Posted (Estimate)

January 19, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11.08.002

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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