Culture and Characterization of Circulating Tumor Cells (CTC) in Melanoma and Other Cancers

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Comprehensive Cancer Centers of Nevada
Sponsor:
Collaborators:
TrueCells, LLC
Comprehensive Cancer Centers of Nevada
University of Pittsburgh
Information provided by (Responsible Party):
Wolfram Samlowski, Comprehensive Cancer Centers of Nevada
ClinicalTrials.gov Identifier:
NCT01528774
First received: February 6, 2012
Last updated: February 5, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to determine if circulating tumor cells (CTC) can be accurately detected and isolated from the blood of participants with melanoma using novel laboratory techniques. Blood samples will be collected from participants with melanoma, and also from participants with other solid tumor cancers and healthy volunteers for purposes of comparison.

Relevant information will be collected from participant's medical record and stored in a coded manner in a password-protected format. This information will be used to look for correlations of research results on blood samples to participant's medical condition. Test results will not be given to participants or their physicians. In some cases, CTC may be grown for long-term cell lines for further research.


Condition Intervention
Melanoma
Other: Blood Draw

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Culture and Characterization of Circulating Tumor Cells (CTC) From Patients With Malignant Melanoma and Other Cancers

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Centers of Nevada:

Primary Outcome Measures:
  • Circulating tumor cell (CTC) isolation and colony counts [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunophenotyping, somatic (tumor-specific) DNA mutation analysis [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood (up to 40 cc) collected in four 7.5 - 10 ml tubes. Serum samples may be stored frozen in a coded, de-identified format until DNA or RNA is extracted for assays to allow for batch processing. Samples will be consumed in the course of the research studies. Viable tumor cells may be grown as long-term cell lines.


Estimated Enrollment: 1000
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Melanoma
Patients with histologically confirmed melanoma
Other: Blood Draw
Approximately 40 cc of blood will be drawn from participants at a time when they are having blood drawn for routine or treatment-related purposes. Sequential samples may be obtained in the same manner from selected patients to allow exploration of potential correlation of CTC with response to treatment, progression-free survival and overall survival.
Prostate
Patients with histologically confirmed prostate cancer
Other: Blood Draw
Approximately 40 cc of blood will be drawn from participants at a time when they are having blood drawn for routine or treatment-related purposes. Sequential samples may be obtained in the same manner from selected patients to allow exploration of potential correlation of CTC with response to treatment, progression-free survival and overall survival.
Solid tumors - other
Patients with histologically confirmed solid tumor cancers other than melanoma and prostate
Other: Blood Draw
Approximately 40 cc of blood will be drawn from participants at a time when they are having blood drawn for routine or treatment-related purposes. Sequential samples may be obtained in the same manner from selected patients to allow exploration of potential correlation of CTC with response to treatment, progression-free survival and overall survival.
Benign Hematologic Conditions
Patients diagnosed with non-cancerous hematologic conditions
Other: Blood Draw
Approximately 40 cc of blood will be drawn from participants at a time when they are having blood drawn for routine or treatment-related purposes. Sequential samples may be obtained in the same manner from selected patients to allow exploration of potential correlation of CTC with response to treatment, progression-free survival and overall survival.
Healthy Volunteers
Family members of patients undergoing treatment at Comprehensive Cancer Centers of Nevada, or other healthy volunteers
Other: Blood Draw
Approximately 40 cc of blood will be drawn from participants at a time when they are having blood drawn for routine or treatment-related purposes. Sequential samples may be obtained in the same manner from selected patients to allow exploration of potential correlation of CTC with response to treatment, progression-free survival and overall survival.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants will be recruited from patients receiving treatment for cancer at Comprehensive Cancer Centers of Nevada. Healthy volunteers (family members of CCCN patients or other volunteers) will also be accepted for study control purposes.

Criteria

Inclusion Criteria:

  • Diagnosis of melanoma, prostate cancer or other solid tumor malignancy; or benign hematologic disorder; or healthy volunteer.
  • 18 years of age or older.
  • Signed written informed consent.

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528774

Contacts
Contact: Wolfram Samlowski, MD 702-952-1251 wolf.samlowski@usoncology.com
Contact: Joyson Pekkattil 702-952-3714 joyson.pekkattil@usoncology.com

Locations
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89148
Contact: Wolfram Samlowski, MD    702-952-1251    wolf.samlowski@usoncology.com   
Contact: Joyson Pekkattil    702-952-3714    joyson.pekkattil@usoncology.com   
Sponsors and Collaborators
Wolfram Samlowski
TrueCells, LLC
Comprehensive Cancer Centers of Nevada
University of Pittsburgh
Investigators
Principal Investigator: Wolfram Samlowski, MD Comprehensive Cancer Centers of Nevada
  More Information

No publications provided

Responsible Party: Wolfram Samlowski, Physician, Comprehensive Cancer Centers of Nevada; Member, Developmental Therapeutics and Genitourinary Committee, US Oncology Research Clinical; Professor, University of Nevada, Reno, Comprehensive Cancer Centers of Nevada
ClinicalTrials.gov Identifier: NCT01528774     History of Changes
Other Study ID Numbers: 12.01.015
Study First Received: February 6, 2012
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Centers of Nevada:
Melanoma
Circulating Tumor Cells
Prostate cancer
Sarcoma
Renal Cancer
Pancreatic neuroendocrine cancer
Other solid tumor

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Melanoma
Neoplastic Cells, Circulating
Neoplastic Processes
Nevi and Melanomas
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014