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Table 3 The complete clinical trials of circulating tumor cells (CTCs) in colorectal cancer

From: Potential theranostics of circulating tumor cells and tumor-derived exosomes application in colorectal cancer

Clinical trials.gov identifier/(refs.) Investigator, country/year Condition/patient no. Methods Short description
NCT02450422/The detection of circulating tumor cells (CTCs) in patients with CRC undergoing cryosurgery combined with DC-CIK treatment Wang, China/2013–2015 II–IV/60 Flow cytometry
RT-PCR
Test CTCs from patients received cryosurgery and/or DC-CIK treatment, 1 day before and 2 days after
NCT01640444/Influence of BRAF and PIK3K status in patients with RAS wild-type metastatic colorectal carcinoma and < 3 CTC (VISNU-2) Díaz-Rubio, Aranda, Sastre, Spain/2012–2018 Metastatic/240 CTC count Influence of BRAF and PIK3K status on the efficacy of FOLFIRI + Bevacizumab or Cetuximab
NCT01163305/PET-CT and CTCs in CRC Brigette, Hong Kong/2010–2017 Metastatic/84 PETScan, RECIST Criteria Assessing Chemotherapy (oxaliplatin or irinotecan) response (measuring tumor metabolic)
 NCT01943500/Collection of blood specimens for CTC analysis Sanz-Altamira, USA/2012–2017 II–IV/14 CTC count Test the sensitivity of a proprietary filtration device designed to capture and concentrate CTCs
NCT03337347/Clinical significance of detecting CEA and CK20 mRNA-positive cells in CRC patients Duda, Czech Republic/2004–2017 I–IV/256 CTC count
RT-PCR
Determine the correlations of CTC in the blood and bone marrow of CRC patients with CEA and CK20 mRNA-positive cells as a negative prognostic factor
NCT01628328/Colonic stent and tumor cell dissemination Poon, Hong kong/2010–2012 II–IV/40 FACS Assess impact of metallic stent insertion for obstructing measuring the level of CTCs before and after colonoscopic stenting vs colonoscopy 
NCT01722903/Detection of CTCs in patients undergoing surgery for stage IV CRC Kaifi, USA/2012–2015 Metastatic/26 FMSA device
Cell search
Detection of CTCs during CRC syn- and metachronous liver and lung metastases
NCT01212510/Study of circulating markers in serum of patients treated for metastatic CRC (Coca-Colon) Michel and Rouen, France/2010–2016 Metastasis/200 CTC count
Real-time RT-PCR
Measure of tumor markers (blood rate of ACE, CA19-9, CTC, ctDNA)
NCT00351572/Frequency of CTCs in stage II and stage III colon cancer patients Sawyer, Canada/2006–2006 II–III/30 Cell search Detect of CTC in patients who have had surgery for CRC presence and recurrence
NCT01640405/Study of first line treatment of patients with metastatic CRC not previously treated and with three or more CTC (VISNU-1) Díaz-Rubi and Aranda and Sastre, Spain/2012–2018 Metastasis/350 CTC count To evaluate FOLFOX + bevacizumab versus FOLFOXIRI + bevacizumab as first line treatment of patients with metastatic CRC not previously treated and with three or more CTCs
Determine the Correlation of RAS, BRAF and PI3K mutations and clinical anti-tumor activity outcome (PFS, OS, RR)
NCT02029326/Biomarker analysis in metastatic colorectal cancer treated with cetuximab Samsung Medical Center, Korea/2013–2017 Metastasis/30 Onco dX assay To analyze expression and activation status of receptor tyrosine kinases in signal transduction pathways in FNA samples and CTCs and identify negative predictive markers to cetuximab and analyze correlation between the quantity of CTCs and treatment response to cetuximab
 NCT03640572/Disseminated tumor cells (DTC) in left sided colorectal cancer (LSCC) Antoni Szczapanik, Assoc, Poland/2018–2019 Metastasis/91 Bone marrow analysis The incidence of DTC was not related to the depth of infiltration (T feature) being similar in T1–2 and T4 patients
There was no statistically significant difference between the incidence of DTC in N− and N+ patients. The 5 years survival rate for the DTC patients was 59, 5% while for the DTC negative patients was 53%
NCT02186236/Detection of oncogenic tumor mutations in the urine and blood of lung and colorectal cancer patients Memorial Sloan Kettering Cancer Center, USA/2014–2019 IV/84 Molecular analyses Determine the presence of EGFR mutation in CTC and in cfDNA or RAS/RAF mutation by urine or plasma-based assay as compared to the gold standard of tumor tissue
NCT03008499/High-activity natural killer immunotherapy for small metastases of colorectal cancer Fuda Cancer Hospital, Guangzhou, China/2016–2019 Patient refuses standard therapies after cancer recurrence/20 Determine the safety and the short and long term efficacy of high-activity natural killer cells that evaluated according to local relief degree, PFS and OS
 NCT03357276/Mix vaccine for metastatic colorectal cancer Fuda Cancer Hospital, Guangzhou, China/2016–2019 Patient refuses standard therapies after cancer recurrence/30 Determine the safety and the short and long term efficacy of mix vaccine that evaluated according to local relief degree, PFS and OS
NCT03031691/A study of brontictuzumab with chemotherapy for subjects with previously treated metastatic colorectal cancer OncoMed Pharmaceuticals, Inc, USA/2017–2019 Metastasis/7 Determine the safety and pharmacodynamics of brontictuzumab in combination with chemotherapy for subjects with previously treated metastatic CRC
Meanwhile, patients went under screening period during treatment period and a post-treatment follow up period in which patients will be followed for survival
 NCT02080650/Characterization of circulating tumor cells captured by c-MET (CTC-MET) Andrew J Armstrong, USA/2014–2017 Metastasis/62 Mesenchymal-marker based ferrofluid (c-MET) and Epithelial cell adhesion molecule (EpCAM) ferrofluid Determine whether CTCs can be captured using the cMET based ferrofluid
Describe the detection rates of both the c-MET CTC capture and the EpCAM CTC capture techniques in each patient
NCT00924092/An open label phase I Study to eval the safety and tolerability of a vaccine (GI-6207) consisting of whole, heat-killed recombinant saccharomyces cerevisiae (yeast) genetically modified to express cea protein in adults with metastatic CEA-expressing Ravi A Madan, M.D. USA/2009–2019 Metastasis/25 Molecular analyses Determine the safety and tolerability of escalating doses of a heated-killed yeast-based vaccine that targets tumors that express CEA
Evaluate CD4 and CD8 immunologic response to yeast antigen. To evaluate evidence of clinical benefit such as PFS, OR and CTCs decreasing via assessment of tumor markers
NCT00560560/Study using CP-751,871 in patients with stage iv colorectal cancer that has not responded to previous anti-cancer treatments Pfizer CT.gov Call Center Pfizer, USA, Spain and United Kingdom/2007–2013 IV/168 CTC count This study will test if there is any survival benefit in patients with refractory metastatic colorectal cancer that receive CP-751,871
NCT00483080/Study of NGR-hTNF as single agent in patients affected by colorectal cancer (CRC) MolMed S.p.A. Italy/2006–2013 Metastasis/46 Evaluation of the safetly of NGR-hTNF on patients who previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens and correlation with survival
NCT00335595/Study of bevacizumab alone or combined with capecitabine and oxaliplatin as support therapy in metastatic colorectal cancer patients Enrique Aranda, M.D.; ph.D., Eduardo Díaz-Rubio, M.D.; ph.D. and Spanish Cooperative Group for Gastrointestinal Tumor Therapy (TTD), Spain/2006–2013 Metastasis/480 CTC count Compare the free time to disease progression of combination therapy with capecitabine, oxaliplatin and bevacizumab until disease progression versus capecitabine, oxaliplatin and bevacizumab for 6 cycles followed by bevacizumab until disease progression or a premature drop out of the study
NCT02020291/Phase I study to evaluate safety, tolerability, anti-tumour activity and pk profiles of foxy-5 in metastatic breast, colon or prostate cancer WntResearch AB, Denmark/2013–2016 Metastasis/31 CTC count Develop Foxy-5 as a first in class anti-metastatic cancer drug via inhibition the development of metastasis by reducing the motility of cancer cells and increasing the survival rates of patients
  1. RR response rate, PFS progress free survival, OS overall survival