Table V.
Clinical trials focusing on circulating tumor cells and/or circulating free DNA (cfDNA).
| ClinicalTrials.gov identifier/(Refs.) | Start date | Title | Sponsors, collaborators and investigators (location) | Short description | Condition(s) |
|---|---|---|---|---|---|
| NCT02639832 (183) | First received: December 10, 2015; Last updated: August 8, 2016 | A pilot surveillance study to monitor Natural Killer Cells and Circulating Tumor Cells in women with previously treated non-metastatic triple negative breast cancer and women with previously treated non-metastatic breast cancer with a confirmed BRCA miitntinn | Sponsor: Cynvenio Biosystems, Inc. (Westlake Village, CA, USA) | The purpose was to test blood for the presence of tumor derived Triple-negative breast circulating tumor cells (CTCs) or circulating tumor DNA (ctDNA) cancer using an investigational medical device. This LiquidBiopsy® device is able to purify low numbers of tumor cells or low amounts of ctDNA in the blood. Even if a tumor is too small to be found by other means such as an x-ray, it is possible that ctDNA or CTCs may be found in the blood. Genetic information can then be recovered from these cells or DNA to look for genetic changes that are related to the abnormal growth in a tumor. This will potentially allow researchers to study tumor cells or tumor DNA from a blood sample instead of a biopsy sample. This may influence cancer diagnosis, treatment and drug selection in the future | Triple-negative breast cancer |
| NCT02626039 (l84) | First received: October 15, 2015; Last updated: March 9, 2017 | Characterization & comparison of drugable mutations in primary and metastatic tumors, CTCs and cfDNA in MBC patients | Sponsor: Hospital General Universitario Gregorio Marañon; Principal investigator: Martín M (Hospital General Universitario Gregorio Marañon, Madrid, Spain) | In the study, it is hypothesized that breast cancer métastasés and Metastatic breast primary tumors can harbor different genomic profiles related to cancer genomic regions of interest in a clinically relevant proportion of metastatic breast cancer patients. Furthermore, the genomic aberrations found in the metastatic breast cancer tissue can also be detected in circulating tumor cells (CTCs) and cfDNA. The study will evaluate whether CTCs and cfDNA would be convenient, non-invasive, easily accessible sources of genomic material for the analysis of mutations and other genomic aberrations | Metastatic breast cancer |
| NCT02186236 (185) | First received: July 7, 2014; Last updated: September 27, 2016 | Detection of oncogenic tumor mutations in the urine and blood of lung and colorectal cancer patients | Sponsor: Memorial Sloan Kettering Cancer Center; Collaborator: Trovagene, Inc. ; Principal investigator: Yu H (Memorial Sloan Kettering Cancer Center | The purpose of the study is to determine whether gene mutations Lung cancer; can be found in the urine or blood of patients with lung cancer and colorectal cancer the urine of patients with colorectal cancer. The study is based on gene mutations that are only found in lung and colorectal cancer cells, but not in normal cells. In the study, a plasma-based assay is applied to determine the presence of EGFR mutation in CTC and in cfDNA | Lung cancer; colorectal cancer |
| NCT02788084 (186) | First received: May 25, 2016; Last updated: June 27, 2017 | Development of a tissue-based & cell free DNA next-generation sequencing workflow | Sponsor: Alberta Health Services, Calgary; Principal investigator: Mähe E (FRCPC; Calgary Laboratory Services, University of Calgary) | In the study, blood samples will be prospectively collected scheduled follow-up and if the primary objectives of this study are met, the presence of cfDNA and the impact of variation on clinical outcomes will be assessed. A next generation sequencing (NGS) workflow will be developed for the mutation profiling of cfDNA specimens. The major issue is to calculate the proportion of cases in a test series of B-cell non-Hodgkin lymphomas (BNHL) with somatic mutations or immunoglobulin heavy chain (IGH) gene rearrangements. Participant data will be collected, and clinical outcomes will be assessed to determine the effect of mutation profiles on outcomes over a two-year follow-up | Non-Hodgkin lymphoma |
| NCT02883517 (187) | First received: August 25, 2016; Last updated: February 23, 2017 | Cell-free circulating DNA in primary cutaneous lymphomas | ^ Sponsor: University Hospital, Bordeaux; Principal Investigator: Pham-Ledard A (University Hospital, Bordeaux, France) | This study is based on the concept that liquid biopsies allowing the detection of tumor mutation in plasma have been validated in nodal diffuse large B-cell lymphoma. The purpose of the study is to evaluate the possibility to detect cell-free circulating tumor DNA in primary cutaneous lymphomas, using a highly sensitive method (digital PCR), combined with a next generation sequencing panel of the tumor sample | Lymphoma, large B-cell |
| NCT02887612 (188) | First received: May 14, 2016; Last updated: January 17, 2018 | ctDNA for prediction of relapse in gastric cancer | Sponsor: Sun Yat-sen University; Principal Investigator: Xu R (Sun Yat-sen University) | By monitoring the serum ctDNA mutational profile using NGS, the present clinical trial aims to elucidate the association between the serum ctDNA status and the prognosis of patients with early and intermediate-stage gastric cancer upon surgical treatment, and to explore the possibility of clinical utility of serum ctDNA as a clinical index to predict post-operative relapse. Furthermore, by comparing the molecular profiles of patients with different prognosis, it will be possible to identify molecular markers related to the prognosis of gastric cancer | Stomach neoplasms |
| NCT02738593 (189) | First received: April 6, 2016; Last updated: April 14,2016 | Detection Cell Free DNA in lung cancer patients | :Sponsor: Sun Yat-Sun University Cancer Center (Guangzhou, China); Principal investigator: Zhang L (Sun University Cancer Center, Guangzhou, China) | The study is based on next generation sequencing as the most sensitive and specific method to examine gene mutation and diversion. Eligible patients receiving 3rd generation EGFR-TKIs (AZD9291 and AVITINIB) were enrolled in this study. Tumor tissue sample within 6 months, and 10 ml peripheral blood samples were collected at baseline. Following treatment initiation, 10 ml peripheral blood would be collected at every image testing time point until disease progression. Blood samples will be draw using EDTA tube and centrifuged within 2 h and store at −80°C in a refrigerator. NGS testing will cover target genes of non-small cell lung cancer | Non-small cell lung cancer |
| NCT02610218 (190) | First received: November 18, 2015; Last updated: October 31, 2017 | Liquid biopsy in monitoring the therapeutic efficacy of targeted therapy in advanced/meta-static gastric cancer | Sponsor: Peking University (Beijing, China) | The study is undertaken in patients with both histologically HER2-positive and -negative advanced/metastatic gastric cancer. Peripheral blood samples are collected from the patients for cfDNA and CTC analysis (before therapy, at the time that the patients achieve the optimal response and when they suffer progressive disease). The enumeration of CTCs, as well as the detection of HER2 expression will be achieved via the integrated subtraction enrichment (SET) and immunostaining-fluorescence in situ hybridization (iFISH) platform. Furthermore, for the genomic analysis, the enriched single CTC will be isolated for single-cell targeted sequencing. While for cfDNA analysis, extracted DNA from plasma will be directly subjected to targeted sequencing. The association of the HER2 status on CTCs and the HER2 amplification in cfDNA to the therapeutic response will be evaluated. Moreover, genetic variations associated with resistance in HER2-targeted therapy will be also studied based on the genomic data from sequencing of CTC and cfDNA | Gastric cancer |
| NCT02872779 (191) | First received: August 16, 2016; Last updated: August 22, 201 | Correlation between circulating tumour markers early variations and 7 clinical response in first line treatment of metastatic colorectal cancer (COCA-MACS) | Sponsor: University Hospital, Rouen (Rouen, France); Principal investigator: Gangloff A (University Hospital, Rouen, Rouen, France) | The aim of the present study is to evaluate, in a prospective cohort of patients treated with systemic IV chemotherapy (5-fluorouracil +/− oxaliplatin +/− irinotecan) +/− targeted therapy as first line treatment for metastatic colorectal cancer, the correlation between early variations of circulating tumor markers including CEA, circulating tumor DNA and total cell free DNA, and the 3-month objective response as defined in the RECIST 1.1 guideline | Metastatic colorectal cancer |
| NCT02443948 (192) | First received: March 19, 2015; Last updated: February 14, 2017 | Circulating cell-free tumor DNA in the plasma of patients with gastrointestinal stromal tumors (GIST) | Sponsor: Fondazione del Piemonte per l'Oncologia | This study is based on the fact that cf-DNA may become an efficient marker of the mutational GIST status and disease itself. On this basis, this trial aims to evaluate whether tumor DNA carrying mutations (for KIT, PDGFRa, BRAF, RAS and SDH) can be detected and quantified in the plasma of patients with GISTs, either with active disease or during follow-up, and whether detection can be associated with the disease status | Gastrointestinal stromal tumor (GIST) |
| NCT02133222 (193) | First received: April 30, 2014; Last updated: October 21, 2016 | Circulating cell-free DNA in metastatic melanoma patient: Mutational analyses in consecutive measurement before and after chemotherapy ÍAMMAM) | Sponsor: Centre Hospitalier Universitaire de Nice (Nice, France); Principal investigator: Long-Mira E (CHU de Nice, Nice, France) | In recent years, BRAF and KIT have become established therapeutic targets in patients with melanoma showing activating mutations in these oncogenes. However, it is crucial that genetic mutations present in the melanoma lesions are identified if the investigators are to design tailormade therapies for individual patients. The aim of the study is to determine the mutational status in circulating DNA in patients with melanoma metastatic, with the Sequenom Mass Array, a next generation sequencing technology. Results obtained before and after treatment will be comnared with the nrimarv tumor 2enotvne | Metastatic (Stage IV) melanoma |
| NCT02934984 (194) | First received: October 13, 2016; Last updated: October 17, 2016 | Circulating cell-free tumor DNA (ctDNA) in pancreatic cancer | Sponsor: Samsung Medical Center (Seoul, Republic of Korea) | In this study, ctDNA of patients with pancreatic cancer who underwent surgery will be collected, and it will be evaluated whether peripheral ctDNA can aid in the early screening of cancer recurrence. The genomic signature of ctDNA will be determined to evaluate the association between ctDNA and the clinical outcome of cancer patients | Pancreatic cancer |
| NCT02784639 (195) | First received: May 24, 2016; Last updated: August 3, 2016 | Comparison of KRAS/BRAF mutational status with conventional techniques and plasma samples analysis | Sponsor: Y chou M (Institut régional du Cancer de Montpellier, Montpellier, France); Principal investigator: Y chou M (Institut régional du Cancer de Montpellier, Montpellier, France) | In this study, a method is employed which simultaneously allows the determination of three parameters: The specific quantification of tumor-derived ccfDNA, the ccfDNA fragmentation index, and single nucleotide polymorphism (SNP) or point mutation detection. The evaluation and validation of the method will be performed by determining the KRAS/BRAF mutational status before anti-EGFR therapy in patients with colorectal cancer. The protocol will detect the six more frequent KRAS mutations in CRC (G12D, G12V, G13D, G12S, G12C and G12A) and the BRAF V600E. The goal of this multicenter prospective study is to validate, and ultimately translate into routine clinical practice, the use of plasma analysis of cfDNA for the determination of KRAS mutation status in patients with metastatic colorectal cancer | Colorectal cancer |
| NCT02036216 (196) | First received: January 7,2014; Last updated: January 14, 2014 | Circulating cell-free DNA as a predictive biomarker for hepatocelluar carcinoma | Sponsor: Peking Union Medical College Hospital (Beijing, China); Collaborator: Stanford University; Principal investigator: Mao Y (Peking Union Medical College Hospital (Beijing, China) | This study is based on technologies exhibiting high sensitivity and specificity detection developed at the Stanford Genome Technology Center. Some cfDNA characteristic changes, such as pl61NK4A, RTL, RASSF1A, LINE-1 and GSTP1, will be examined in hepatocellular carcinoma, since studies have shown that cfDNA level is associated with 1 intrahepatic and extra-hepatic metastasis in patients with hepatocellular carcinoma. In the study, these characteristic changes in cfDNA and primary tumor lesions will be investigated. The possible applications in early diagnosis, treatment monitoring and prognosis for hepatocellular carcinoma will be evaluated | Hepatocellular carcinoma |
| NCT02791217 (197) | First received: May 30, 2016; Last updated: June 6, 2016 | Identification of hematological malignancies and therapy predication using microRNAs as a diagnostic tool | Sponsor: Assuta Medical Center; Collaborator: Laniado Hospital | The objective of the trial is related to the early diagnosis of very aggressive hematological malignancies as an essential approach for improving prognosis and increasing survival rates. The early diagnosis is based on the analysis of circulating miRNAs, considering that current diagnostic methods have various limitations, such as insufficient sensitivity, specificity, require time-consuming and costly approaches, and a high level of expertise, limiting applications in clinical contexts. Thus, the development of novel biomarkers (miRNAs) for the early detection and relapse of hematological malignancies is desirable. The approach is based on the readily-made detection of miRNAs in small-volume samples using specific and sensitive quantitative PCR | Lymphoma, B-Cell; follicular lymphoma; Hodgkin lymphoma; multiple myeloma |
| NCT02928627 (198) | First received: October 7, 2016; Last updated: October 25, 2017 | Clinical significance of hepatic and circulating microRNAs miR-221 and miR-222 in hepatocellular carcinoma | Sponsor: University of Aberdeen; Collaborator: Robert Gordon University; Principal investigator: Soggiu F (NHS Grampian) | It has been shown that miRNAs play a role in the development of hepatocellular carcinoma, but it is unknown whether these molecules can be used as markers for diagnosis and survival in hepatocellular carcinoma. In particular, the miRNAs miR-221 and miR-222 are dysregulated in tumor tissues in approximately 80% of patients with hepatocellular carcinoma. The aim of this study is to evaluate whether these two miRNAs are expressed not only in tumor tissues, but also in blood from cancer patients, and in different amounts compared to circulating levels in healthy individuals. The possible association between tumor tissue and blood levels will also be evaluated | Hepatocellular carcinoma |
| NCT02964351 (199) | First received: November 8, 2016; Last updated: November 16, 2016 | MicroRNA profiles identification in adenocarcinoma prostate cancer | Sponsor: Assuta Medical Center; Principal investigator: Goldberg N (Assuta Medical Center) | The main objective of the study is to determine whether an association exists between circulating miRNAs associated with prostate cancer métastasés to bones and to lymph nodes, analyzed by positron emission computed (PET) imaging. miRNA profiles will be assessed by using nano-string technology validated by real-time PCR | Prostate carcino-sarcoma |
| NCT01541800 (200) | First received: February 24, 2012; Last updated: February 5, 2016 | Circulating microRNAs as disease markers in pediatric cancers | Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago; Principal investigator: Lulla R (Ann & Robert H Lurie Children's Hospital of Chicago) | This study is aimed to evaluate the presence of miRNAs in the blood f and cerebrospinal fluid of patients with central nervous system tumors, leukemia and lymphoma who are currently being treated with & chemotherapy and are undergoing blood draws, lumbar punctures and/or reservoir taps for routine clinical care | Leukemia; lymphoma; central nervous system |