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

NCT01528774 | Completed

• 1 other identifier: 12.01.015
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma

Keywords

Melanoma; Circulating Tumor Cells; Prostate cancer; Sarcoma; Renal Cancer; Pancreatic neuroendocrine cancer; Other solid tumor

Outcome Measures

Primary Outcomes (1)

• Circulating tumor cell (CTC) isolation and colony counts

  2 years

Secondary Outcomes (1)

• Immunophenotyping, somatic (tumor-specific) DNA mutation analysis

  2 years

Study Arms (5)

Melanoma

Patients with histologically confirmed melanoma

Other: Blood Draw

Prostate

Patients with histologically confirmed prostate cancer

Other: Blood Draw

Solid tumors - other

Patients with histologically confirmed solid tumor cancers other than melanoma and prostate

Other: Blood Draw

Benign Hematologic Conditions

Patients diagnosed with non-cancerous hematologic conditions

Other: Blood Draw

Healthy Volunteers

Family members of patients undergoing treatment at Comprehensive Cancer Centers of Nevada, or other healthy volunteers

Other: Blood Draw

Interventions

Blood Draw OTHER

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; Healthy Volunteers; Melanoma; Prostate; Solid tumors - other

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Wolfram Samlowski: lead
• TrueCells, LLC: collaborator
• Comprehensive Cancer Centers of Nevada: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148, United States

Location

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.

MeSH Terms

Conditions

Melanoma; Neoplastic Cells, Circulating; Prostatic Neoplasms; Sarcoma; Kidney Neoplasms; Somatostatinoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasms, Connective and Soft Tissue; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases; Carcinoma, Neuroendocrine; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma, Islet Cell; Pancreatic Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Wolfram Samlowski, MD

  Comprehensive Cancer Centers of Nevada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician, Comprehensive Cancer Centers of Nevada; Member, Developmental Therapeutics and Genitourinary Committee, US Oncology Research Clinical; Professor, University of Nevada, Reno

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 8, 2012
• Study Start: June 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 26, 2017

Record last verified: 2017-07

Locations

US (1)