High Definition Single Cell Analysis in Colorectal Cancer

Status Completed

Clinical Trial Summary

This research clinical trial studies high definition single cell analysis in blood and tissue samples from patients with colorectal cancer which has spread to the liver. High definition single cell analysis allows doctors to study the properties of cancer cells that are sometimes found in the blood of patients and to determine how the genes and proteins in them may change over time. Studying samples from patients with colorectal cancer in the laboratory may help doctors learn more about how cancer spreads, as well as how to predict the disease outcomes in patients with cancer.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the level of correlation between solid tumor touch preparations and liquid biopsies (circulating tumor cells [CTCs]) from patients with surgically resected colorectal cancer (CRC) metastases to the liver using single-cell high-content analysis, including gene copy number variation (CNV) and to establish one or more bio-signatures that represent the liquid and solid biopsy correlation for each patient and for the patient population. SECONDARY OBJECTIVES: I. To demonstrate the technical validity and reproducibility of the bio-signatures by comparing the two pre-resection liquid biopsy samples drawn one week prior to and on the day of surgery. TERTIARY OBJECTIVES: I. Compare biosignatures between pre-surgical and post-surgical blood samples. II. Compare biosignatures between resected metastatic liver tumor tissue, primary colon tumor tissue (if available), and pre-surgical blood samples. III. Compare biosignatures between blood samples prior to resection with those obtained after resection and at the time of recurrence. OUTLINE: Patients undergo blood collection 1 week prior surgery, before and after surgery on the same day, and 1 week and 3 months after surgery. Patients also undergo tissue collection during the surgery. Blood and tissue samples are processed for high definition single cell analysis including whole-genome CNV profiles, protein expression, and cell morphology. After completion of study, patients are followed up for up to 2 years. ;

Study Design

Related Conditions & MeSH terms

Colorectal Neoplasms
Metastatic Carcinoma in the Liver
Stage IV Colorectal Cancer

Clinical Trial Details

NCT number	NCT02809716
Study type	Observational
Source	University of Southern California
Contact
Status	Completed
Phase
Start date	August 1, 2016
Completion date	May 29, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01704703` - Study of FOLFIRI + Panitumumab Using Ultra-selection Technology of Patients With Stage IV Colorectal Cancer Refractory to Irinotecan Without Any Mutation on KRAS, PIK3Ca, BRAF and NRAS Genes Detected With Highly Sensitive Techniques	Phase 2
Terminated	`NCT02960282` - Gut Microbiome in Fecal Samples From Patients With Metastatic Cancer Undergoing Chemotherapy or Immunotherapy
Completed	`NCT01998152` - Individualized Nutritional Counselling During Chemotherapy for Colorectal Cancer (COLONUT)	N/A
Not yet recruiting	`NCT06287723` - French Assessment of MRD by Liquid Biopsies in Colorectal With Liver Metastasis Patients (FRENCH.MRD.CRLM)
Completed	`NCT03005002` - Durvalumab and Tremelimumab in Treating Patients With Microsatellite Stable Metastatic Colorectal Cancer to the Liver	Phase 1
Completed	`NCT03095781` - Pembrolizumab and XL888 in Patients With Advanced Gastrointestinal Cancer	Phase 1
Terminated	`NCT03111823` - Exercise Program During Chemotherapy in Metastatic Colorectal Cancer	N/A
Active, not recruiting	`NCT04267575` - Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites	N/A
Recruiting	`NCT03368963` - TAS102 in Combination With NAL-IRI in Advanced GI Cancers	Phase 1/Phase 2
Active, not recruiting	`NCT04670445` - Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer	N/A
Active, not recruiting	`NCT01271582` - Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients	Phase 4
Active, not recruiting	`NCT03800602` - Nivolumab and Metformin in Patients With Treatment Refractory MSS Colorectal Cancer	Phase 2
Recruiting	`NCT05631574` - Study of Covalent Menin Inhibitor BMF-219 in Adult Patients With KRAS Driven Non-Small Cell Lung Cancer, Pancreatic Cancer, and Colorectal Cancer	Phase 1
Completed	`NCT03112668` - Acceptance and Commitment Therapy in Improving Well-Being in Patients With Stage III-IV Cancer and Their Partners	N/A
Terminated	`NCT01550510` - Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA	Phase 1/Phase 2
Recruiting	`NCT02919644` - Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer.	Phase 2
Completed	`NCT03373188` - VX15/2503 and Immunotherapy in Resectable Pancreatic and Colorectal Cancer	Phase 1
Terminated	`NCT04044430` - Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer	Phase 1
Completed	`NCT05025748` - Ask Questions (ASQ):Implementation of a Communication Intervention	N/A
Completed	`NCT01722903` - Detection of CTCs in Patients Undergoing Surgery for Stage IV Colorectal Cancer	N/A