High Definition Single Cell Analysis in Colorectal Cancer
NCT ID: NCT02809716
Last Updated: 2023-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
24 participants
OBSERVATIONAL
2016-08-01
2020-05-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
Biomarker Analysis
Correlative studies
Cytology Specimen Collection Procedure
Undergo collection of blood and tissue samples
Interventions
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Biomarker Analysis
Correlative studies
Cytology Specimen Collection Procedure
Undergo collection of blood and tissue samples
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Peter Kuhn
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Scripps Cancer Center
La Jolla, California, United States
Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Countries
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Other Identifiers
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NCI-2016-00736
Identifier Type: REGISTRY
Identifier Source: secondary_id
3C-15-4
Identifier Type: OTHER
Identifier Source: secondary_id
3C-15-4
Identifier Type: -
Identifier Source: org_study_id
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