Table 3 The complete clinical trials of circulating tumor cells (CTCs) 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 |