Table 2. Selection of ongoing trials related to CTCs of solid tumors. (According:https://clinicaltrials.gov/; assessment date:08/11/2016).
| ClinicalTrials.gov Identifier | Title/study | No of patients | Time period | Primary endpoints | Cancer type |
|---|---|---|---|---|---|
| CTCs as biomarkers or therapeutic targets | |||||
| NCT01548677 | Trastuzumab in HER2-negative Early Breast Cancer as Adjuvant Treatment for Circulating Tumor Cells (CTC) (“TREAT CTC” Trial) | 2175 | Apr 2013- Dec 2018 | CTCs detection | Breast cancer |
| NCT01619111 | DETECT III - A Multicenter, Randomized, Phase III Study to Compare Standard Therapy Alone Versus Standard Therapy Plus Lapatinib in Patients With Initially HER2-negative Metastatic Breast Cancer and HER2-positive Circulating Tumor Cells | 120 | Feb 2012-Mar 2018 | CTC clearance rate | Breast cancer |
| NCT01975142 | Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment. | 480 | Oct 2013-Nov 2016 | Tumor response rate to T-DM1 in patients with HER2 amplified CTCs | Breast cancer |
| NCT01349842 | CirCe01 Study: Evaluation of the Use of Circulating Tumour Cells to Guide Chemotherapy From the 3rd Line of Chemotherapy for Metastatic Breast Cancer | 568 | Jan 2010-Jan 2018 | OS | Breast cancer |
| NCT00382018 | S0500 Treatment Decision Making Based on Blood Levels of Tumor Cells in Women With Metastatic Breast Cancer Receiving Chemotherapy | 651 | Oct 2006-May 2017 | OS, PFS | Breast cancer |
| Predictive, diagnostic and prognostic value of CTCs | |||||
| NCT02610764 | Pilot Study: Resectable Esophageal Adenocarcinoma and the Relevance of CTC (ESO-CTC) | 20 | Nov 2015-Dec.2017 | Changes of CTC numbers | Esophageal cancer |
| NCT02035813 | DETECT IV - A Prospective, Multicenter, Open-label, Phase II Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs). | 520 | Jan 2014-Dec 2019 | PFS | Breast cancer |
| NCT01322893 | Enumeration and Molecular Characterization of Circulating Tumor Cells in Women With Metastatic Breast Cancer | 150 | Mar 2011-Dec 2016 | CTC numbers | Breast cancer |
| NCT02626039 | Characterization & Comparison of Drugable Mutations in Primary and Metastatic Tumors, CTCs and cfDNA in MBC patients (MIRROR) | 40 | Nov 2013-Dec 2016 | Mutations and genomic alterations in primary tumor tissue and metastases | Breast cancer |
| NCT02119559 | Assessment of Circulating Tumor Cells as an Early Predictive Marker of Response to a First Line Treatment Based on an Anti-Human Epidermal Growth Factor Receptor (HER), Cetuximab, in Patients With Inoperable Recurrent and/or Metastatic HNSCC. | 115 | Sep 2012-Mar 2018 | Predictive value of CTCs on PFS | Head and neck squamous cell carcinoma |
| NCT02554448 | Detection of CTCs in Stage III Rectal Cancer Patients Undergoing Neoadjuvant Therapy | 80 | Jan 2016-Dec 2016 | CTC numbers | Rectal cancer |
| NCT01596790 | Assessment by EPISPOT of Circulating Tumor Cells as an Early Predictive Marker of Response to Chemotherapy and Targeted Therapy in Patients With Metastatic Colorectal Cancer in First Line of Treatment | 168 | Apr 2012-Apr 2016 | Predictive value of CTCs on PFS | Colorectal Cancer |
| NCT01848015 | Prediction of Recurrence in Advanced Gastric Cancer After Radical Resection by Circulating Tumor Cells (CTCs) | 200 | Jun 2013-Jul 2016 | CTC as predictive marker for recurrence | Gastric cancer |
| NCT01625702 | Clinical Significance of Circulating Tumor Cells (CTCs) in Blood of Patients With Advanced/Metastatic Gastric Cancer | 100 | Jun 2012-Dec 2015 | CTC as prognostic marker | Gastric cancer |
| NCT02072616 | Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma | 142 | Sep 2014-Sep 2021 | Sensitivity of CTCs as diagnostic marker | Pancreatic cancer |
| NCT02451384 | Comparison of the Influences of Different Methods to Remove the Pancreatic Ductal Adenocarcinoma on the Detection of Circulating Tumor Cells | 45 | Jul 2015-Dec 2016 | CTCs between the pre and post-operation in each study arm | Pancreatic ductal adenocarcinoma |
| NCT02155426 | A Multicenter, Prospective, Observational Trial on the Prognostic and Dynamic Change of CTC Enumeration in Advanced NSCLC With 1st or 2nd Line Chemotherapy and Targeted Therapy | 1200 | Apr 2014-Dec 2016 | Baseline CTC count | Non-small cell lung cancer |
| NCT02407327 | Individualized Treatment of Patients With Advanced NSCLC: Potential Application for Circulating Tumor Cells (CTC) Molecular and Phenotypical Profiling (2012/52) | 150 | Dec 2013-Dec 2017 | Percentage of CTC-positive patients and total CTC numbers | Non-small cell lung cancer |
| NCT02500693 | Circulating Tumor Cells and Early Diagnosis of Lung Cancer in Patients With Chronic Obstructive Pulmonary Disease | 600 | Nov 2015-Dec 2019 | CTC detection rate | Lung cancer |
| NCT02372448 | Multicenter Validation of the Sensitivity of Theranostic ALK Rearrangement Detection by FISH Analysis and Prevalence of Escaping Mutations in Circulating Tumor Cells for the Non-invasive Management of Lung Cancer Patients | 224 | Jul 2014-Jul 2016 | Sensitivity and specificity of the FISH technique in CTC assessment | Lung cancer |
| NCT02666612 | Measurement and Characterization of Circulating Endothelial Cells or Circulating Tumor Cells in Adult Patients With Metastatic Cancer | 1000 | Aug 2008-Aug 2020 | Metastatic cancer | |
| NCT01961713 | Circulating Tumor Cell Analysis in Patients With Localized Prostate Cancer Undergoing Prostatectomy | 200 | Apr 2010-Apr 2019 | Prostate cancer | |
PFS: Progression Free Survival; OS: Overall Survival CEC: circulating endothelial cells; EPC: endothelial progenitors cells