Culture and Characterization of Circulating Tumor Cells (CTC) in Melanoma and Other Cancers
This study is currently recruiting participants.
Verified April 2013 by Comprehensive Cancer Centers of Nevada
Sponsor:
Wolfram Samlowski
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: April 26, 2013
Last verified: April 2013
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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 2014 |
| Estimated Primary Completion Date: | January 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528774
Contacts
| Contact: Wolfram Samlowski, MD | 702-952-1251 | wolf.samlowski@usoncology.com |
| Contact: Linda Cortes | 702-952-3400 ext 5363 | linda.cortes@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: Linda Cortes 702-952-3400 ext 5363 linda.cortes@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: | April 26, 2013 |
| 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:
|
Melanoma Neoplastic Cells, Circulating Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Neoplasm Metastasis Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013