High Definition Single Cell Analysis in Colorectal Cancer
3 other identifiers
observational
24
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2016
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2016
CompletedFirst Posted
Study publicly available on registry
June 22, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2020
CompletedAugust 14, 2023
August 1, 2023
3.8 years
June 19, 2016
August 9, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
HD-SCA liquid biopsy biosignatures assessed by cell morphology, protein expression, and whole genome CNV profiles
Biosignatures will be compared between cells from tumor tissue within the same patient, cells from blood samples within the same patient, cells from tumor tissue and blood samples within the same patient, cells from tumor tissue and blood samples across different patients. Upon these comparisons, biosignatures will be established which represent liquid and solid biopsy correlations for each patient and for the patient population. Descriptive statistics will be used to determine means, correlations, and variability of biosignatures between different specimens and time points, and within and acr
Up to 2 years
HD-SCA solid tumor biosignatures assessed by cell morphology, protein expression, and whole genome CNV profiles
Biosignatures will be compared between cells from tumor tissue within the same patient, cells from blood samples within the same patient, cells from tumor tissue and blood samples within the same patient, cells from tumor tissue and blood samples across different patients. Upon these comparisons, biosignatures will be established which represent liquid and solid biopsy correlations for each patient and for the patient population. Descriptive statistics will be used to determine means, correlations, and variability of biosignatures between different specimens and time points, and within and acr
Up to 2 years
Secondary Outcomes (1)
HD-SCA biosignatures in pre-resection liquid biopsy samples assessed by cell morphology, protein expression, and whole genome CNV profiles
Up to day 1 of surgery
Study Arms (1)
Ancillary-Correlative (blood and tumor tissue collection)
Patients undergo collection of 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 and 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.
Interventions
Undergo collection of blood and tissue samples
Eligibility Criteria
Patients with metastatic CRC with single- and multi-focal hepatic lesions scheduled for resection (metastatectomy)
You may qualify if:
- Able to provide informed consent
- Metastatic colorectal adenocarcinoma to the liver (hepatic mCRC)
- Synchronous or metachronous
- Solitary or multifocal
- Concurrent abdominal lymph node metastasis is allowable
- Hepatic mCRC deemed surgically resectable by the study team with plans to undergo surgery
- Has not received any systemic chemotherapy for at least 21 days prior to scheduled hepatic resection
You may not qualify if:
- Non-adenocarcinoma metastatic colorectal cancer (e.g. neuroendocrine carcinoma); mucinous component is permitted
- Metastatic CRC that involves organ(s)/tissue(s) other than abdominal lymph nodes and/or liver
- Has received any systemic chemotherapy within 21 days prior to scheduled hepatic resection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- National Cancer Institute (NCI)collaborator
Study Sites (6)
Scripps Cancer Center
La Jolla, California, 92037, United States
Los Angeles County-USC Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, 92663, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030, United States
Biospecimen
Blood, tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Kuhn
University of Southern California
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2016
First Posted
June 22, 2016
Study Start
August 1, 2016
Primary Completion
May 29, 2020
Study Completion
May 29, 2020
Last Updated
August 14, 2023
Record last verified: 2023-08