Cultured Circulating Tumor Cells in Prostate and Other Cancers
1 other identifier
observational
220
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedFirst Posted
Study publicly available on registry
April 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedJanuary 19, 2015
January 1, 2015
3 years
February 3, 2014
January 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate novel CTC assay method as a predictive tool for prostate, breast and colorectal cancers.
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 Outcomes (4)
Sensitivity and specificity comparison
Baseline, post treatment (up to 12 months)
Develop in vitro assay for chemotherapy sensitivity testing
Baseline, post treatment (up to 12 months)
IC50 correlation with CTC response and clinical outcome
Baseline, post treatment (up to 12 months)
Attempt growth of long-term tumor cell lines for evaluation
Baseline, post treatment (up to 12 months)
Study Arms (5)
Prostate Cancer
Breast Cancer
Colorectal Cancer
Solid Tumor
Benign Condition
Eligibility Criteria
Participants will be having blood drawn at Comprehensive Cancer Centers of Nevada as part of their routine care.
You may qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oscar Goodman, Jr.lead
- Comprehensive Cancer Centers of Nevadacollaborator
- Roseman University of Health Sciencescollaborator
Study Sites (1)
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
Related Publications (9)
Halabi S, Small EJ, Kantoff PW, Kattan MW, Kaplan EB, Dawson NA, Levine EG, Blumenstein BA, Vogelzang NJ. Prognostic model for predicting survival in men with hormone-refractory metastatic prostate cancer. J Clin Oncol. 2003 Apr 1;21(7):1232-7. doi: 10.1200/JCO.2003.06.100.
PMID: 12663709BACKGROUNDTannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.
PMID: 15470213BACKGROUNDCollette L, Burzykowski T, Carroll KJ, Newling D, Morris T, Schroder FH; European Organisation for Research and Treatment of Cancer; Limburgs Universitair Centrum; AstraZeneca Pharmaceuticals. Is prostate-specific antigen a valid surrogate end point for survival in hormonally treated patients with metastatic prostate cancer? Joint research of the European Organisation for Research and Treatment of Cancer, the Limburgs Universitair Centrum, and AstraZeneca Pharmaceuticals. J Clin Oncol. 2005 Sep 1;23(25):6139-48. doi: 10.1200/JCO.2005.08.156.
PMID: 16135480BACKGROUNDBudd GT, Cristofanilli M, Ellis MJ, Stopeck A, Borden E, Miller MC, Matera J, Repollet M, Doyle GV, Terstappen LW, Hayes DF. Circulating tumor cells versus imaging--predicting overall survival in metastatic breast cancer. Clin Cancer Res. 2006 Nov 1;12(21):6403-9. doi: 10.1158/1078-0432.CCR-05-1769.
PMID: 17085652BACKGROUNDSmerage JB, Hayes DF. The measurement and therapeutic implications of circulating tumour cells in breast cancer. Br J Cancer. 2006 Jan 16;94(1):8-12. doi: 10.1038/sj.bjc.6602871.
PMID: 16317435BACKGROUNDAllard WJ, Matera J, Miller MC, Repollet M, Connelly MC, Rao C, Tibbe AG, Uhr JW, Terstappen LW. Tumor cells circulate in the peripheral blood of all major carcinomas but not in healthy subjects or patients with nonmalignant diseases. Clin Cancer Res. 2004 Oct 15;10(20):6897-904. doi: 10.1158/1078-0432.CCR-04-0378.
PMID: 15501967BACKGROUNDCohen SJ, Punt CJ, Iannotti N, Saidman BH, Sabbath KD, Gabrail NY, Picus J, Morse MA, Mitchell E, Miller MC, Doyle GV, Tissing H, Terstappen LW, Meropol NJ. Prognostic significance of circulating tumor cells in patients with metastatic colorectal cancer. Ann Oncol. 2009 Jul;20(7):1223-9. doi: 10.1093/annonc/mdn786. Epub 2009 Mar 12.
PMID: 19282466BACKGROUNDde Bono JS, Scher HI, Montgomery RB, Parker C, Miller MC, Tissing H, Doyle GV, Terstappen LW, Pienta KJ, Raghavan D. Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer. Clin Cancer Res. 2008 Oct 1;14(19):6302-9. doi: 10.1158/1078-0432.CCR-08-0872.
PMID: 18829513BACKGROUNDDanila DC, Heller G, Gignac GA, Gonzalez-Espinoza R, Anand A, Tanaka E, Lilja H, Schwartz L, Larson S, Fleisher M, Scher HI. Circulating tumor cell number and prognosis in progressive castration-resistant prostate cancer. Clin Cancer Res. 2007 Dec 1;13(23):7053-8. doi: 10.1158/1078-0432.CCR-07-1506.
PMID: 18056182BACKGROUND
Biospecimen
* Fifteen (15) cc whole blood (two - 7.5 cc tubes) will be collected and processed for research tests. * Patients with prostate, breast or colorectal cancer will have an additional ten (10) cc whole blood collected for commercial CTC assay as part of standard care.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Physician, Comprehensive Cancer Centers of Nevada; Adjunct Professor of Pharmaceutical Sciences, Roseman University of Health Sciences
Study Record Dates
First Submitted
February 3, 2014
First Posted
April 28, 2014
Study Start
April 1, 2014
Primary Completion
April 1, 2017
Study Completion
April 1, 2018
Last Updated
January 19, 2015
Record last verified: 2015-01